October « 2007 « Drugs Log

Archive for October, 2007

Axitinib: great results for the new cancer drug

Tuesday, October 30th, 2007

New cancer drug A phase II trial on axitinib, a new experimental drug for treating patients with cytokine-refractory, metastatic kidney cancer who have a poor response to more traditional drugs has shown promising results according to a new study published in the The Lancet Oncology.

Professor Olivier Rixe of the University of Paris, France, and colleagues assessed the activity and safety of axitinib in a group of patients with metastatic renal-cell cancer who had failed to respond to cytokine-based treatments.

The researchers enrolled 52 patients between October 2003 and April 2004. Each patient had at least one measurable lesion that could be targeted and was given an oral dose of axitinib starting at 5 mg twice a day.

Rixe and colleagues assessed the percentage of patients who responded either completely or partially using the Response Evaluation Criteria In Solid Tumors (RECIST) method, as well as how long they took to respond, the time to progression, overall survival, safety and other measures.

In an intention to treat analysis, the study produced the following results:

Of the 52 patients, 2 responded completely and 21 partially.
This equated to an objective response rate of 44.2 per cent.
The median response rate was 23.0 months (range 4.2 to 29.8 months).
But 12 of 23 initial responders progressed with response durations of 4.2 to 26.5 months.
Also, 22 patients showed stable disease for more than 8 weeks, with 13 of them for 24 weeks or more.
4 patients had early disease progression, 3 had missing response data.
Median time to progression was 15.7 months (range 0.03 to 31.5 months).
Median overall survival was 29·9 months (range 2·4 to 35·8 months).
Adverse events linked to treatment included diarrhoea, hypertension, fatigue, nausea, and hoarseness.
High blood pressure was found in 30 patients.
Of these, all but 8 responded to blood pressure treatment. 7 of the 8 had a history of high blood pressure at enrollment.

The researchers concluded that:

“Axitinib shows clinical activity in patients with cytokine-refractory metastatic renal-cell cancer. Although 28 patients had grade 3 or grade 4 treatment-related adverse events, these adverse events were generally manageable and controlled by dose modification or supportive care, or both. Further studies are needed to confirm these findings.”

Kidney cancer is the sixth leading cause of cancer deaths in the US, and thought to be responsible for nearly 13,000 deaths a year. Kidney cancer is actually a range of cancers, each with a different histology or tissue characteristics. Each type of kidney cancer also develops differently and needs different kinds of treatment.

The most common type of kidney cancer is clear-cell renal cancer, found in 75 per cent of kidney cancer patients.

There are few treatment options for kidney cancer and most patients die. Even with chemotherapy, hormone or biological therapy with the latest targeted drugs, the survival rate is rarely more than 10 per cent.

Axitinib is a selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3. By selectively targeting a single growth factor receptor pathway, treatments with this drug could provide a way to adjust dosage and combine with other drugs aimed at specific parts of the pathway. This would potentially minimise toxicity as well as optimise therapeutic outcomes suggested the researchers.

Rixie said that although a randomized controlled trial was now needed:

“The objective response and time to progression in our study suggest that axitinib might be a promising drug in the treatment of patients with metastatic renal-cell cancer.”

In an accompanying article in the same issue of the journal, Dr W Marston Linehan of the US National Cancer Institute, said that these findings “suggest that a drug such as axitinib has promise as a second-line treatment in cytokine-refractory metastatic renal-cell carcinoma, and might have potential as first-line treatment or in combination with other agents targeting the Von Hippel-Lindau pathway (or both).”

(more…)

Posted in Cancer drugs, Drugs and Medications, New drugs, Research | No Comments »

Rates of high cholesterol problems among young people increase

Tuesday, October 30th, 2007

Cholesterol drugs Use of cholesterol and blood pressure medicines by young adults appears to be rising rapidly — at a faster pace than among senior citizens, according to an industry report being released Tuesday.

Experts point to higher rates of obesity, high blood pressure and high cholesterol problems among young people. Also, doctors are getting more aggressive with preventive treatments.

“This is good news, that more people in this age range are taking these medicines,” said Dr. Daniel W. Jones, president of the American Heart Association.

Still, he said many more people should be on the drugs that lower cholesterol or blood pressure and which have been shown to reduce risks for heart attack and stroke.

The new data, from prescription benefit manager Medco Health Solutions Inc., indicate use of cholesterol-lowering drugs among people aged 20 to 44, while still low, jumped 68 percent over a six-year period.

The rate rose from 2.5 percent in 2001 to just over 4 percent in 2006 among Medco customers. That means roughly 4.2 million Americans in that age group are now taking cholesterol medicines.

Meanwhile, use of blood pressure medicines increased 21 percent, from about 7 percent of 20- to 44-year-olds in 2001 to over 8 percent in 2006. That translates into about 8.5 million Americans in that age group taking drugs to lower their blood pressure.

“It was a surprise to us,” said Dr. Robert Epstein, chief medical officer at Franklin Lakes, N.J.-based Medco. “Maybe the fact that we’re seeing more young people with high cholesterol and blood pressure is indicative of the epidemic of obesity and overweight that we’re seeing in this country.”

Among people 65 and older, use of blood pressure drugs increased only 9.5 percent and use of cholesterol drugs by 52 percent. That’s because half the seniors were already taking blood pressure drugs and more than one in four were taking cholesterol drugs in 2001.

Jones, dean of the University of Mississippi School of Medicine, said he has seen some increase in young adults with blood pressure or cholesterol problems, but not of the magnitude suggested by Medco’s data.

Dr. Howard Weintraub, the heart disease prevention expert at the American College of Cardiology, said he’s “thrilled” by the dramatic increase, which he says is tied to requests from patients with “a brand new sense of urgency” and referrals from other doctors to his private practice.

“If you wait until a heart attack or stroke, it’s a little bit late,” Weintraub said.

He and Epstein both said patients with problems should first work with their doctors on lifestyle changes — more exercise, a better diet and weight loss. But Weintraub said many people need medication to achieve and maintain the ever-lower levels of blood pressure and cholesterol that experts now recommend.

However, Dr. John LaRosa, president of SUNY Downstate Medical Center, said, “particularly for young people, lifestyle change is worth a try.”

Once patients start taking these medicines, they usually stay with them and there are some side effects, LaRosa said.

“It’s amazing what (losing) five or 10 pounds will do” to reduce blood pressure and cholesterol levels, he said.

Federal health statistics show that while the percentage of people with high cholesterol has dropped overall in recent years, it has risen among younger people, especially those 20 to 34 years old.

Meanwhile, the prevalence of high blood pressure was flat or up slightly among those age groups; among women in the 35 to 44 age group, the rate of high blood pressure rose significantly.

Medco processes prescription claims for about 60 million insured Americans. The report’s findings are based on a representative sample of data from 2.5 million members.

Increase in use of cholesterol and hypertension medications largest among people ages 20 to 44Drop in the age of women using heart disease medications greater than men

Heart disease, high blood pressure and hardening of the arteries - conditions that are usually associated with the senior population - are creeping into young adulthood. According to new research conducted by Medco Health Solutions, Inc. , prescription drug use by younger adults for heart disease- related conditions is increasing at a rapid rate, far outpacing older adults and offering a glimpse into the forthcoming clinical and financial challenges facing the nation’s health care system.

The analysis shows that between 2001 and 2006, the number of 20-44 year olds taking prescription medications to treat high cholesterol increased 68 percent, and use of antihypertensives jumped 21 percent.

Based on this new analysis, the estimated number of 20-44 year olds nationwide on lipid-lowering drugs surged from 2.5 million in 2001 to 4.2 million in 2006, while the number of people of that age taking antihypertensives spiked from 7 million to 8.5 million in the six-year period.

“This may be both a good news, bad news story,” said Dr. Robert Epstein, Medco’s chief medical officer. “The good news is that younger patients are taking medications that control conditions that, if left untreated, could lead to heart attacks and strokes - indicating that physicians are screening patients more regularly and treating these precursors more aggressively than in the past. The bad news is that these conditions are showing up in patients at younger ages, which could be the result of the growing obesity epidemic and various lifestyle factors.”

Not only were the increases among 20-44 year olds significant, but so too were the rates of increase when compared to age groups more traditionally associated with these categories of medications. The increase in the number of 20-44 year-olds on lipid-lowering medications was 37 percent higher than it was for 45 to 64 year olds; the growth in prevalence of those on antihypertensives was 52 percent greater. When compared with patients 65 years or older, the increase in usage of lipid-lowering medications was 31 percent higher in the 20-44 group, and among those on antihypertensives it was more than double.

Decline Seen in Age of Patients on Drug Treatment

The analysis also found a significant shift downward in the age of patients using these drug treatments. In 2006, half of all patients on lipid- lowering drugs were 61 years old or younger; the median age of women fell more sharply than men, dropping from 67 to 62 in the six-year span, as compared to 62 to 59 for men.

The median age of those using antihypertensives declined four years over the six-year period, with half of all patients on these drugs being 60 years or younger in 2006; again women had the greatest decline, dropping from 65 to 60 versus men whose median age fell from 63 to 60.

“There is a history of women being under-diagnosed and under-treated for heart conditions,” said Epstein. “The fact that more women at a younger age are receiving medication treatment for high cholesterol and hypertension is a sign that the medical community is recognizing that heart disease is a serious threat to women as well as men.”

Heart Disease Risks

High cholesterol and high blood pressure are two of the leading risk factors for heart disease, heart attack and stroke. High LDL cholesterol can cause atherosclerosis, a narrowing and hardening of the arteries that feed the heart and brain. High blood pressure, or hypertension, can weaken the arterial walls and make them more prone to atherosclerosis. Both conditions can lead to blood clots that can block blood flow and result in a heart attack or stroke.

For some people with high cholesterol and hypertension, lifestyle changes such as weight loss, dietary changes and exercise can control the conditions. For others, medications may be needed. The most common medications used to treat high cholesterol are statins. To treat hypertension, diuretics, beta- blockers and ACE inhibitors are often prescribed.

Posted in Blood pressure medicines, Cholesterol-modifying medicines, Drugs and Medications | No Comments »

New research on Parkinson’s disease

Saturday, October 27th, 2007

Anti-Parkinson medications Your brain is supposed to fire a “hold your horses” signal when faced with a tough choice. But a brain implant that stops the tremors of Parkinson’s disease may block that signal — a new explanation for why some Parkinson’s patients become hugely impulsive.

Scientists have long known that anti-Parkinson medications occasionally spark compulsions like pathological gambling.

Research published Thursday found another treatment, a pacemaker-like brain implant, can trigger a completely different kind of impulsiveness. How different? The drugs leave a subset of patients unlikely to learn from bad experiences, like a losing poker hand.

The brain implant doesn’t hinder learning. In contrast, those patients can make hasty decisions as the brain loses its automatic tendency to hesitate when faced with conflict, University of Arizona researchers reported online in the journal Science.

In fact, the first patient they studied displayed an alarming example when he saw something across the room he wanted and tried to dash over without his wheelchair. Neuroscientist Michael Frank had to catch the man before he fell.

“Deep brain stimulation,” or DBS, involves placing electrodes into a small region called the subthalamic nucleus, an area important for controlling movement. But it also is where scientists believe the brain yells: “Stop, weigh your options!”

Frank’s theory: When electrodes fire to disrupt excessive movement, they also may block that signal.

“It makes a lot of sense,” said Dr. Valerie Voon, a psychiatrist with the National Institutes of Health’s neurology center, after reviewing the research.

The study doesn’t offer easy solutions. But it could affect how neurologists counsel Parkinson’s patients after DBS surgery.

“Because they don’t have those brakes in place, you need to teach someone to slow down” when faced with certain decisions, Voon said.

At least 1 million Americans have Parkinson’s, suffering increasingly severe tremors and periodically stiff or frozen limbs as brain cells quit producing dopamine, a chemical crucial for movement. There is no cure. Standard treatments include medications to stimulate dopamine and, once those fail, DBS surgery to control tremors.

Doctors have long noticed varying degrees of impulsiveness in Parkinson’s patients, from making uncensored remarks to rare cases of extreme behavior such as compulsive gambling, shopping, eating or sex. Changing medications or doses often solves extreme symptoms — if patients or their families report the worrisome behavior.

Frank wondered what role the brain implant plays.

His team used specialized computer games to probe decision-making in 15 Parkinson’s patients taking dopamine drugs, 17 others who received DBS, and 14 healthy older adults.

First, participants were shown pairs of Japanese characters and told to pick the “correct” one. It was baffling — what makes one symbol better, especially if you don’t know Japanese? But as the computer screen beamed back “Correct!” or “Incorrect!” their brains learned to prefer some characters over others.

Then Frank paired the symbols differently: “Correct” ones together to simulate “win-win” decisions; “incorrect” pairings to model choosing the lesser of two evils; and easy “right-wrong” pairs.

Healthy people and Parkinson’s patients on dopamine drugs hesitated briefly when faced with win-win or lose-lose choices, allowing time to weigh options. But DBS patients didn’t hesitate with lose-lose choices — and actually sped up win-win decisions.

Remarkably, switch off the brain implant and DBS patients quit rushing the close calls.

As in previous research, medicated patients were less likely to learn which “wrong” symbols to avoid, backing the theory that dopamine drugs can hinder learning from negative feedback.

But do the DBS patients’ hasty choices really matter in a win-win situation, where there’s no clearly wrong answer?

In the real world, definitely, said Arizona’s Frank. Say your job offers a range of 401K options. Sure, any one is better than no investment, but just grabbing the first one might not be the most lucrative.

It hasn’t been obvious that different treatments cause different impulsive behaviors, said Dr. Kathleen Shannon of Chicago’s Rush University Hospital.

“They all seem to make bad decisions and have trouble making decisions,” she said. Now, “I’ll start to look at my patients differently.”

What is Parkinson’s Disease?

Parkinson’s disease (PD) belongs to a group of conditions called motor system disorders, which are the result of the loss of dopamine-producing brain cells. The four primary symptoms of PD are tremor, or trembling in hands, arms, legs, jaw, and face; rigidity, or stiffness of the limbs and trunk; bradykinesia, or slowness of movement; and postural instability, or impaired balance and coordination. As these symptoms become more pronounced, patients may have difficulty walking, talking, or completing other simple tasks. PD usually affects people over the age of 50. Early symptoms of PD are subtle and occur gradually. In some people the disease progresses more quickly than in others. As the disease progresses, the shaking, or tremor, which affects the majority of PD patients may begin to interfere with daily activities. Other symptoms may include depression and other emotional changes; difficulty in swallowing, chewing, and speaking; urinary problems or constipation; skin problems; and sleep disruptions. There are currently no blood or laboratory tests that have been proven to help in diagnosing sporadic PD. Therefore the diagnosis is based on medical history and a neurological examination. The disease can be difficult to diagnose accurately. Doctors may sometimes request brain scans or laboratory tests in order to rule out other diseases.

Is there any treatment?

At present, there is no cure for PD, but a variety of medications provide dramatic relief from the symptoms. Usually, patients are given levodopa combined with carbidopa. Carbidopa delays the conversion of levodopa into dopamine until it reaches the brain. Nerve cells can use levodopa to make dopamine and replenish the brain’s dwindling supply. Although levodopa helps at least three-quarters of parkinsonian cases, not all symptoms respond equally to the drug. Bradykinesia and rigidity respond best, while tremor may be only marginally reduced. Problems with balance and other symptoms may not be alleviated at all. Anticholinergics may help control tremor and rigidity. Other drugs, such as bromocriptine, pramipexole, and ropinirole, mimic the role of dopamine in the brain, causing the neurons to react as they would to dopamine. An antiviral drug, amantadine, also appears to reduce symptoms. In May 2006, the FDA approved rasagiline to be used along with levodopa for patients with advanced PD or as a single-drug treatment for early PD.

In some cases, surgery may be appropriate if the disease doesn’t respond to drugs. A therapy called deep brain stimulation (DBS) has now been approved by the U.S. Food and Drug Administration. In DBS, electrodes are implanted into the brain and connected to a small electrical device called a pulse generator that can be externally programmed. DBS can reduce the need for levodopa and related drugs, which in turn decreases the involuntary movements called dyskinesias that are a common side effect of levodopa. It also helps to alleviate fluctuations of symptoms and to reduce tremors, slowness of movements, and gait problems. DBS requires careful programming of the stimulator device in order to work correctly.

What is the prognosis?

PD is both chronic, meaning it persists over a long period of time, and progressive, meaning its symptoms grow worse over time. Although some people become severely disabled, others experience only minor motor disruptions. Tremor is the major symptom for some patients, while for others tremor is only a minor complaint and other symptoms are more troublesome. No one can predict which symptoms will affect an individual patient, and the intensity of the symptoms also varies from person to person.

What research is being done?

The National Institute of Neurological Disorders and Stroke (NINDS) conducts PD research in laboratories at the National Institutes of Health (NIH) and also supports additional research through grants to major medical institutions across the country. Current research programs funded by the NINDS are using animal models to study how the disease progresses and to develop new drug therapies. Scientists looking for the cause of PD continue to search for possible environmental factors, such as toxins, that may trigger the disorder, and study genetic factors to determine how defective genes play a role. Other scientists are working to develop new protective drugs that can delay, prevent, or reverse the disease.

Posted in Anti-Parkinson medications, Drugs and Medications, Research | No Comments »

Viagra, Levitra, Cialis linked to hearing loss

Tuesday, October 23rd, 2007

Viagra The US Food and Drug Administration has decided to put more prominent warnings of potential hearing loss on impotence drugs Viagra, Cialis and Levitra.

An FDA statement said the goal was “to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.”

Revatio, used to treat pulmonary hypertension, also will get the same labelling changes, the FDA said.

The warnings followed what the administration called “a very small number” of patients reporting hearing loss and at times ringing in the ears and dizziness.

“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, MD, FDA deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

Anti-impotence drugs linked to hearing loss

The U.S. Food and Drug Administration has approved labelling changes for three kinds of erectile dysfunction drugs to display more prominently the potential risk of sudden hearing loss.

The FDA on Thursday asked manufacturers of Viagra, Cialis and Levitra to revise product labelling after a very small number of patients taking the drugs reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

It’s not clear if the drugs actually trigger hearing loss, but the agency decided to act after counting 29 reports of hearing problems since 1996 among users.

Dr. Robert Boucher, an agency ear, nose and throat specialist, said in reviewing the reports he noticed that the hearing loss occurred within hours to two days of taking one of the drugs.

“We don’t know enough to say that it’s ironclad caused by the drugs, but we see enough to say we can’t ignore it either,” he said.

The reports involved hearing loss in one ear, which in a third of cases was temporary.

The FDA has urged patients who experience any hearing problems, loss or ringing in the ears to promptly call their doctors and stop taking the impotence drugs.

Because some level of hearing loss is usually associated with the aging process, patients taking these drugs (phosphodiesterase type 5 inhibitors) may not think to talk to their doctor about it, said Dr. Janet Woodcock, the FDA’s chief medical officer.

Posted in Anti-impotence drugs, Drugs and Medications, Erectile dysfunction | No Comments »

Superbug causing ear infections

Sunday, October 21st, 2007

An emerging “superbug” that causes ear infections in children and is resistant to multiple antibiotics can only be treated with an adult medication, researchers report.

Two Rochester, N.Y., pediatricians report finding a multiple antibiotic-resistant strain of Streptococcus pneumoniae that caused ear infections in nine children in their practice over three years. The only antibiotic that was effective in treating these infections was levofloxacin, which isn’t approved by the U.S. Food and Drug Administration for use in children.

“We found a superbug causing ear infections in Rochester — the Legacy strain — that’s resistant to all antibiotics approved by the FDA for use in children,” said the study’s lead author, Dr. Michael Pichichero, a professor of microbiology, immunology and pediatrics at the University of Rochester Medical Center, and a private practice pediatrician with the Legacy Pediatric Group.

The resistant infections accounted for only 1.5 percent of the ear infections in their practice, Pichichero noted.

The findings are published in the Oct. 17 issue of the Journal of the American Medical Association.

Pneumococcal infections are caused by S. pneumoniae, and can include ear infections, sinus infections, pneumonia, meningitis and bloodstream infections. Some of these infections can be life-threatening. Young children are most susceptible to pneumococcal infections, according to the U.S. Centers for Disease Control and Prevention. Fortunately, the serious forms of the disease are rare, causing about 4,500 illnesses each year. However, pneumococcal infections cause more than 3 million ear infections each year, according to the CDC.

While a vaccine (brand name Prevnar) is available that covers seven strains of pneumococcal disease, a strain dubbed serotype 19A isn’t currently one of them. However, the vaccine’s manufacturer, Wyeth Pharmaceuticals, reports that it’s currently in phase III trials of the next generation vaccine, which does include serotype 19A.

“Prevnar is a fantastic vaccine that is taking care of the top seven strains of pneumococcal disease, but after you’ve knocked down the other strains, of course others will become more prominent,” Pichichero explained.

Dr. Peter Paradiso is vice president of scientific affairs for Wyeth Pharmaceuticals. He said, “When we developed Prevnar, we had hoped that the response to serotype 19F would provide some cross-protection against 19A.” When it became clear that there was no cross-protection, and other strains needed to be addressed, Wyeth added six more strains to the next generation vaccine. The company plans to begin the regulatory filings needed for FDA approval sometime in 2009, after the phase III trials are completed, he said.

In the meantime, Pichichero said physicians need to do more ear tap procedures to identify which bacteria are causing antibiotic-resistant ear infections. Doing so, he said, would help avoid the unnecessary use of antibiotics and allow for a more targeted approach to treating ear infections.

From 2003 until 2006, Pichichero and his colleagues saw just over 1,800 youngsters with ear infections, according to the study. Of those children, 212 had ear taps, known as tympanocentesis, a procedure that draws fluid out from behind the ear drum. Much like when a tooth cavity is filled, children are given local anesthetic to make the procedure pain-free.

Using this procedure, the doctors found that 59 of the ear infections were caused by S. pneumoniae. One particular strain of the bacterium — serotype 19A — had developed a new genotype that was resistant to all of the antibiotics approved for use in children. Pichichero and his colleague, Dr. Janet Casey, dubbed this the Legacy strain. Nine children were found to be infected with this strain.

The only antibiotic effective against this superbug is levofloxacin (brand name, Levaquin). But, levofloxacin has never been approved for use in children. Pichichero said that because previous studies on young animals have suggested that the drug might cause irreversible damage to growing cartilage, the “FDA has put significant barriers for the use of the antibiotics in children.” No such effects have been found in adults, and it’s a commonly used antibiotic in adults.

However, in these nine pediatric cases, no other treatments were effective, and the children were at risk of losing their hearing. Since Pichichero had been involved in previous research on levofloxacin’s use in children, he knew the correct dose to administer, and it was effective.

But, he cautioned, because the drug hasn’t been well studied in children, “I would not allow a child to receive levofloxacin unless I knew for sure [that it was the Legacy strain].”

Dr. Katherine Poehling, a pediatrician at Brenner Children’s Hospital at Wake Forest University Baptist Medical Center, said the new findings are worrisome, but “nine cases out of 1,800 doesn’t make me panic. We’ve always had some ear infections that are very hard to treat, but they usually aren’t serotyped to figure out what they are.”

Poehling, who’s been involved in research on the current pneumococcal vaccine, added that the “pneumococcal conjugate vaccine has been extraordinarily successful, and children continue to benefit from this vaccine.”

Paradiso agreed, adding that the current vaccine has caused a dramatic — 99 percent — reduction in infections in the serotypes that are covered by the vaccine.

The CDC recommends that the current vaccine be given to all infants younger than 24 months of age at 2, 4, and 6 months of age, followed by a booster dose at 12-15 months of age.

What is pneumococcal disease?

Pneumococcal disease is defined as infections that are caused by the bacteria Streptococcus pneumoniae, also known as pneumococcus. The most common types of infections caused by this bacteria include middle ear infections, pneumonia, blood stream infections (bacteremia), sinus infections, and meningitis.

Which children are most likely to get pneumococcal disease?

Young children are much more likely than older children and adults to get pneumococcal disease. Children under 2, children in group child care, and children who have certain illnesses (for example sickle cell disease, HIV infection, chronic heart or lung conditions) are at higher risk than other children to get pneumococcal disease. In addition, pneumococcal disease is more common among children of certain racial or ethnic groups, such as Alaska Natives, Native Americans, and African-Americans, than among other groups.

How prevalent is pneumococcal disease?

Each year in the U.S. Streptococcus pneumoniae causes approximately 480 cases of meningitis, 4,000 cases of bacteremia or other invasive disease in children under the age of 5. Children under 2 average more than 1 middle ear infection each year, many of which are caused by pneumococcal infections. Streptococcus pneumoniae is the most common cause of bacteremia, pneumonia, meningitis and otitis media in young children.

Who is at most serious risk?

Children at increased risk of pneumococcal infections include those with anatomic or functional asplenia (including sickle cell disease), patients taking immunosuppressive chemotherapy, those with congenital and acquired immune deficiency (including HIV infections), those with chronic renal disease and healthy Native American, Alaskan Native, and African American children. Children less than 60 months of age in out-of-home day care are at 2-3 fold higher risk of experiencing invasive pneumococcal infections than children in home care.

What are the symptoms of pneumococcal disease?

Meningitis:
High fever, headache, and stiff neck are common symptoms of meningitis in anyone over the age of 2 years. These symptoms can develop over several hours, or they may take 1 to 2 days. Other symptoms may include nausea, vomiting, discomfort looking into bright lights, confusion, and sleepiness. In newborns and small infants, the classic symptoms of fever, headache, and neck stiffness may be absent or difficult to detect, and the infant may only appear slow or inactive, or be irritable, have vomiting, or be feeding poorly.

Pneumonia:
In adults, pneumococcal pneumonia is often characterized by sudden onset of illness with symptoms including shaking chills, fever, shortness of breath or rapid breathing, pain in the chest that is worsened by breathing deeply, and a productive cough. In infants and young children, signs and symptoms may not be specific, and may include fever, cough, rapid breathing or grunting.

Otitis media:
Children who have otitis media (middle ear infection) typically have a painful ear, and the eardrum is often red and swollen. Other symptoms that may accompany otitis media include sleeplessness, fever and irritability.

Blood stream infections:
Infants and young children with blood stream infections-also known as bacteremia-typically have non-specific symptoms including fevers and irritability.

How serious is pneumococcal disease?

Pneumococcal disease is a very serious illness in young children. Pneumococcal infections are now the most common cause of invasive bacterial infection in U. S. children. In the United States it is estimated that pneumococcal infections cause 100 deaths, 450 cases of meningitis, 4,000 cases of bacteremia or other invasive disease, and 3.1 million cases of otitis media (ear infections) annually in children under 5 years of age.

Meningitis is the most severe type of pneumococcal disease. Of children less than 5 years of age with pneumococcal meningitis, about 5% will die of their infection and others may have long-term problems such as hearing loss. Many children with pneumococcal pneumonia or blood stream infections will be ill enough to be hospitalized; about 1% of children with blood stream infections or pneumonia with a blood stream infection will die of their illness. Nearly all children with ear infections recover, although children with recurrent infections can suffer hearing loss.
How is pneumococcal disease spread?

The bacteria are spread through contact between persons who are ill or who carry the bacteria in their throat. Transmission is mostly through the spread of respiratory droplets from the nose or mouth of a person with a pneumococcal infection. It is common for people, especially children, to carry the bacteria in their throats without being ill from it.

How is pneumococcal disease treated/cured?

Pneumococcal disease is treated with antibiotics. Over the last decade, many pneumococci have become resistant to some of the antibiotics used to treat pneumococcal infections; high levels of resistance to penicillin are common.

Can pneumococcal disease in children be prevented?

In late 2000, the FDA licensed a new vaccine for the prevention of pneumococcal disease in children. The new pneumococcal vaccine, Prevnar® (manufactured by Wyeth-Lederle Vaccines), is a vaccine in which the serotypes are conjugated (or linked) to a protein. This new pneumococcal conjugate vaccine has been shown to be highly effective in preventing invasive pneumococcal disease (such as in young children. In a study of the new vaccine among 37,000 infants in California, the vaccine was over 90% effective in preventing invasive disease among the children studied. The children who received the new vaccine also had 7% fewer episodes of otitis media and a 20% decrease in the number of tympanostomy tubes (ear tubes) placed. The vaccine was also shown to decrease the number of episodes of pneumonia.

CDC conducted a study soon after a vaccine was licensed and found that the vaccine was highly effective in preventing disease in children under 5 years of age. The investigators found that the vaccine was 96% effective against pneumococcal disease in healthy children who received one dose or more and 81% effective in children with medical conditions that put them at risk of pneumococcal disease. The vaccine was also highly effective at preventing pneumococcal disease caused by antibiotic-resistant strains.

Prevnar® is indicated for use in infants and toddlers. The vaccine should be given to all infants younger than 24 months of age at 2, 4, and 6 months of age, followed by a booster dose at 12-15 months of age. Children who are unvaccinated and are 7 to 11 months of age should be given a total of 3 doses (2 months apart) and children age 12 to 23 months should be given a total of 2 doses at least two months apart. Most children who are 24 months of age or older only need one dose of the vaccine.

The Advisory Committee on Immunization Practices (ACIP) also recommends the new pneumococcal childhood vaccine be given to children age 24 to 59 months at highest risk of infection, including those with certain illness (sickle cell anemia, HIV infection, chronic lung or heart disease). Vaccine should be considered for all children aged 24-35 months and other children through 59 months of age with a priority for those at higher risk which includes Alaska Natives, American Indians, or African Americans and those children who attend out-of-home day day care for more than 4 hours per week.

The recently licensed pneumococcal conjugate vaccine, Prevnar®, is the first pneumococcal vaccine that can be used in children under the age of 2 years. However, pneumococcal vaccines for the prevention of disease among children and adults who are 2 years and older have been in use since 1977. Pneumovax® and Pnu-Immune® are 23-valent polysaccharide vaccines that are currently recommended for use in all adults who are older than 65 years of age and for persons who are 2 years and older and at high risk for disease such as persons with sickle cell disease, HIV infection, or other immunocompromising condition.

Campaigns for judicious use of antibiotics may also slow or reverse emerging drug resistance found among pneumococcal infection.

Posted in Drugs and Medications, Ear infections, Infant medicines, Vaccines | No Comments »

Some oral infant medicines are withdrawn from the market

Monday, October 15th, 2007

Infant medicines

Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines

Potential misuse of these infant medicines, not product safety, is driving the voluntary withdrawal
This withdrawal does not affect cough and cold medicines for children age 2 and older
Further evaluation of these oral cough and cold medicines for infants and children will occur at the October 18 and 19 FDA advisory committee meeting

The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines today announced voluntary market withdrawals of oral cough and cold medicines that refer to “infants.” The voluntary withdrawal affects only these “infant” oral medicines, not those intended and labeled for use in children age two and older.

“It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately,” said Linda A. Suydam, D.P.A, president of CHPA. “The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority.”

The branded cough and cold medicines that are being voluntarily withdrawn are:
Dimetapp® Decongestant Plus Cough Infant Drops
Dimetapp® Decongestant Infant Drops
Little Colds® Decongestant Plus Cough
Little Colds® Multi-Symptom Cold Formula
PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)
PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine)
PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
PEDIACARE® Infant Dropper Long-Acting Cough
PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
Robitussin® Infant Cough DM Drops
Triaminic® Infant & Toddler Thin Strips® Decongestant
Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
TYLENOL® Concentrated Infants’ Drops Plus Cold
TYLENOL® Concentrated Infants’ Drops Plus Cold & Cough

This voluntary withdrawal does not affect medicines intended for children age two and older. CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children’s cough and cold medicines from “ask a doctor” before using to “do not use” in children under two years.

CHPA made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19. These recommendations, as well as several additional recommendations, including those proposed by FDA review staff, will be explored further at this meeting.

“These medicines are—and always have been—safe at recommended doses,” Suydam said.

“These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children’s symptoms. But as with all medicines, it’s important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children.”

CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.

What Parents and Caregivers Need to Know: OTC Cough and Cold Medicines and Children

On October 11, the Consumer Healthcare Products Association (CHPA), on behalf of the leading makers of over-the-counter (OTC) cough and cold medicines, announced the voluntary withdrawal of oral infant medications from store shelves. Here are the facts:

The voluntary withdrawal of OTC oral infant cough and cold medicines was initiated by the makers of those medications out of an abundance of caution. This is not a mandatory recall or a safety issue.
Kids’ OTC cough and cold medicines are both safe and effective when used correctly. Rare cases of overdose from misuse, however, have occurred—particularly in infants less than two years of age.
Infants under the age of two are the most vulnerable to the consequences of this misuse.
The voluntary withdrawal only affects oral infant cough and cold medications. It does not affect any other children’s medicines.
OTC pediatric cough and cold medicines affected by this voluntary withdrawal are listed above.

Parents can continue to trust and rely on over-the-counter cough and cold medicines for their children, as they have for generations, because these medicines are safe at recommended doses.

As with any medicine, it is important for parents to read the labels carefully, use these medicines only as directed, and make sure to safely store them out of the reach of children.
Labels currently direct parents and caregivers to “ask a doctor” before giving these medicines to children under two. In September 2007, the makers of these medicines recommended to the U.S. Food and Drug Administration that medicine labels have stronger language instructing that parents “do not use” for children under two to prevent incidents of misuse.

Harm from OTC cough and cold medicines is rare and, when it does occur, is almost always the result of misuse (significant overdose or accidental swallowing due to medicine not being properly stored and secured).

As with all medicines, dosing instructions for all over-the-counter remedies must be read and followed carefully. It is important to remember that any medicine can cause harm if taken or used improperly.
Safe use and safekeeping are extremely important. Giving medicine according to label directions is part of the solution; storing it out of the sight and reach of children is part of it, as well.

Because children under age two are the most vulnerable to the harm caused by the misuse of oral, over-the-counter cough and cold medicines, the makers of these medicines have recommended strengthening their labels to state “Do Not Use” for children under two.

This recommendation, as well as others, will be discussed before a U.S. Food and Drug Administration advisory committee on October 18 and 19. FDA asked for the meeting of outside experts to bring the best science to bear on this important issue.
FDA requested analyses and recommendations from its staff of reviewers, but the agency has not and will not take an official position until after it has the opportunity to discuss and examine all the information.
FDA has not called for a “ban” on or “recall” of these medicines.

The makers of over-the-counter cough and cold medicines want to ensure that parents and caregivers understand when and how to use these medicines safely.

The safe use of these medicines is our highest priority. We will soon launch a major national educational program to build awareness among parents and other caregivers about how to safely use over-the-counter medicines in children, and, as importantly, when not to use them.

Posted in Cold medicines, Cough medicines, Drugs and Medications, Infant medicines | No Comments »

Herbals for erectile dysfunction - be warned!

Monday, October 15th, 2007

herbal-remedies Researchers have warned about “herbal remedies” for erectile dysfunction sold over-the-counter in Hong Kong after most of them were found to contain untested variants of well-known anti-impotence drugs.

These variants, or “analogues,” are copies of controlled drugs but they are slightly modified in their chemical structure to escape patent and other drug-related laws.

Cranked out illegally, these chemicals are not tested for their efficacy or safety and can have unpredictable, adverse effects. They are added undeclared into “health products,” which do not come under stringent tests in most countries.

Writing in the latest issue of the Hong Kong Medical Journal, the scientists said they studied 26 anti-impotence products sold in convenience stores and pharmacies.

Although their packaging declared that they contained only “herbal ingredients,” variants of sildenafil and vardenafil were found in 14 of them. Sildenafil was found in one product.

Sildenafil and vardenafil are generic names for their better known trade labels Viagra and Levitra, respectively, and they are prescribed drugs in Hong Kong.

“The positive rate of concealed drug analogues in male erectile dysfunction health products is alarmingly high. Such analogues are difficult to detect by ordinary laboratory methods and might be used in an attempt to evade regulatory inspection,” wrote the researchers at the Hospital Authority Toxicology Reference Laboratory in the journal’s October issue.

“Without going through the stringent drug testing process, the adverse effects of these chemicals remain largely unknown and unpredictable,” they warned, as they called for urgent and more effective surveillance and control.

“The medical profession and the public should be alerted to this under-recognized threat.”

This malpractice came to light when a previously healthy 28-year-old man got admitted to hospital for an unsteady gait and frequent falls — signs of ataxia.

Doctors then learnt that he had taken an anti-impotence “health product” for over a week before showing those symptoms.

Classified as phosphodiesterase-5 inhibitors, sildenafil and vardenafil are known to have side-effects like nausea, headache, facial flushing and visual disturbances. Serious cardiovascular effects have also been reported.

But ataxia has never been linked to this class of drugs.

“Unlike the parent pharmaceutical, no formal studies have been performed to assure the safety and efficacy of these analogues,” the researchers wrote.

“Evidently, the adverse effects of drug analogues are highly unpredictable and the consumption of such products is dangerous.”

Analogues have also been found in so called “natural” or “herbal” slimming products in Hong Kong and at least one woman has died of a cardiac arrest after consuming them.

What are herbal remedies in short:

Herbal medicine, sometimes referred to as Herbalism, Botanical medicine or Herbology, is the use of plants, in a wide variety of forms, for their therapeutic value. Herb plants produce and contain a variety of chemical compounds that act upon the body and are used to prevent or treat disease or promote health and well-being.

A brief history of herbal medicine.

Humans, and even Neanderthals, have used plants to treat their ailments for at least tens of thousands of years; most likely even longer than that.

The first written accounts of the use of herbs originate in China, although all other civilisations from the ancient world were using plants as natural remedies for their ailments. Western herbal medicine dates back to ancient Greece and its famous doctors like Hippocrates and Galen.

The 15th to 17th centuries were the most popular time for herbalism in Europe. Herbal remedies are still relatively popular today, mainly due to the fact that they are regarded as harmless because they are natural.

The theory of how they work.

As herbal treatments have been around for so long, and in so many cultures, there are numerous ways that they are believed to work. Many explanations lie in the mystical thinking of ancient cultures. Some believe that the appearance of the plant gives an indication of what it can be used to treat; this physical resemblance between the plant and the body part to be cured is known as the “‘Doctrine of Signatures”; a heart shaped plant would be used to treat heart problems, for example.

From the middle ages on, many practitioners have tried to classify herbal remedies by observation of their effects. This is closer to the modern scientific approach of gathering evidence.

Eastern herbal medicine still adheres to the mystical approach in its theories whilst western herbalists tend to use herbs for the ingredients they contain; mixing and matching them in the way that conventional medicine does with modern drugs.

The three main branches of herbal medicine are:
The Western herbal tradition based on Greek, Roman and medieval sources;
The Ayurvedic tradition of India;
Chinese herbal medicine.

Remedies are produced by either taking the whole plant, or just the part of the plant required, and often mixing it with other plants. They are usually boiled in water or alcohol, and made into: herbal teas; herbal decoctions; herbal syrup; herbal tincture; infused oils; salves & ointment/creams.

Scientific evidence and herbal medicine

There is a lot of mysticism behind it. The approach involves: “balancing” the body’s vital energy; the belief that it can treat anything; it is holistic, which is the reason given why no two practitioners will prescribe the same treatment for exactly the same condition in the same person; and they insist that it is natural and therefore safe.

There is no doubt that herbs contain chemical compounds, often many thousands, many of which have a physiological effect on the body. In fact up to 25% of modern medicines are based on plant origins: Aspirin; Quinine; and Digitalis, for example, are well known.

A substance that has a physiological effect on the body is by definition: a drug. Therefore those herbal remedies that have an effect, do so because of the drugs that they contain; and drugs can be beneficial or harmful. Although some very useful drugs are obtained from plant sources, it should be noted that some of the most deadly poisons are also obtained from plants: the alkaloid poisons for example.

There is some scientific evidence to support some herbal remedies. The evidence is not strongly in favour of the remedies that do show up positive results, although it does show up the need for more quality research.

Posted in Anti-impotence drugs, Drugs and Medications, Erectile dysfunction, Herbal remedies, Sexual health | No Comments »

Pfizer is #1 in research spendings. Johnson & Johnson, Microsoft and Ford are left behind

Wednesday, October 3rd, 2007

Pfizer Inc., the world’s largest drugmaker, is the world’s biggest spender on research, the European Commission said Friday.

That means it outranks rival Johnson & Johnson, software giant Microsoft Corp. and auto companies Ford Motor Co. and DaimlerChrysler AG.

Pfizer spent 5.8 billion euros ($8.18 billion) last year to take the top spot from Ford on the EU’s research and development list, which uses figures from the world’s 50 largest companies to chart how much they invest in researching new products.

The four biggest spenders were all from the United States: Pfizer, Ford, J&J, and Microsoft, as pharmaceutical and biotechnology companies sharply increased research spending to overtake technology hardware and equipment.

Major drugmakers are focusing more on research to develop new products that will help them compensate for losing their exclusive rights to sell many of their best-selling drugs.

U.S.-based Merck & Co. raised investment by 24 percent, AstraZeneca PLC by 15 percent, J&J by 13 percent and GlaxoSmithKline PLC by 10 percent, the EU said.

Germany’s DaimlerChrysler, which is changing its name to Daimler AG after the sale of most of its U.S. unit, was Europe’s highest scorer with 5.2 billion euros ($7.34 billion). Britain’s GlaxoSmithKline ranked No. 7, and German engineering giant Siemens AG was at No. 8.

The European Union’s research commissioner, Janez Potocnik, said more European companies needed to invest more of their own money in research.

Worldwide corporate investment in research grew 10 percent last year, riding the wave of global economic growth. Europe-based companies increased their spending at a slower rate, 7.4 percent.

The European Commission looked at spending by 1,000 companies based in Europe and another 1,000 based outside, saying overall these businesses invested 372 billion euros ($525 billion) in research in the last financial year, more than 85 percent of all research investment worldwide.

A few words about Pfizer

Pfizer Incorporated (NYSE: PFE) is a major research-based pharmaceutical company, which ranks number two in sales. The company is based in New York City. It produces the number-one selling drug Lipitor (atorvastatin, used to lower blood cholesterol); the oral antifungal medication Diflucan (fluconazole), the long-acting antibiotic Zithromax (azithromycin), the well-known erectile dysfunction drug Viagra (sildenafil citrate), and the anti inflammatory Celebrex (celecoxib) (also known as Celebra in some countries outside USA and Canada, mainly in South America).

Pfizer’s shares were made a component of the Dow Jones Industrial Average on April 8, 2004.

Pfizer boasts the industry’s largest pharmaceutical R&D organization.

Pfizer is named after German-American cousins Charles Pfizer and Charles Erhardt who launched their chemicals business Charles Pfizer and Company from a building at the intersection of Harrison Avenue and Barlett Street in Williamsburg, Brooklyn in 1849. There, they produced an antiparasitic called santonin. This was an immediate success, although it was the production of citric acid that really kick-started Pfizer’s growth in the 1880s. Pfizer continued to buy property to expand its lab and factory on the block bounded by Bartlett Street; Harrison Avenue; Gerry Street; and Flushing Avenue. That facility is still utilized for Backshop purposes. Pfizer established its original administrative headquarters at 81 Maiden Lane in Manhattan.

By 1910, sales totaled nearly $3 million, and Pfizer became established as an expert in fermentation technology. These skills were applied to the mass production of penicillin during World War II, in response to an appeal from the US government. The antibiotic was urgently needed to treat injured Allied soldiers, and it soon became known as “the miracle drug”. In fact, most of the penicillin that went ashore with the troops on D-Day was made by Pfizer.

By the 1950s, Pfizer was established in Iran, Belgium, Brazil, Canada, Cuba, Mexico, Panama, Puerto Rico and the United Kingdom.

During the 1980s and 1990s Pfizer underwent a period of growth sustained by the discovery and marketing of multiple successful drugs (Zoloft,Lipitor,Norvasc, Zithromax, Aricept, Diflucan, Viagra).

Posted in Drug makers, Pfizer, Research | No Comments »

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