Archive for February, 2008

FDA approved Nexium for kids

Friday, February 29th, 2008

NexiumAstraZeneca Plc’s Nexium drug has been approved in the United States for treating excess stomach acid in children aged 1 to 11, the Food and Drug Administration (FDA) said on Thursday.

The FDA approved Nexium, Astra’s top seller and the world’s second-biggest prescription medicine, in two forms — a delayed response capsule and a liquid — it said in a statement.

It was approved in a dose of 10 milligrams, or 20mg daily, for children aged between 1 and 11, half the dosage for patients aged 12 to 17.

Nexium approved for kids

The Food and Drug Administration has approved use of the drug Nexium in children aged 1 to 11 who have acid reflux disease.

FDA said Thursday it approved liquid and delayed-release capsules of Nexium in doses of 10 milligrams or 20 milligrams for these youngsters. It is already approved in doses of 20 milligrams or 40 milligrams for those aged 12 to 17.

Nexium, manufactured by AstraZeneca of Wilmington, Del., is a type of drug known as a proton pump inhibitor, which reduces the amount of acid produced in the stomach and helps heal damage to the esophagus caused by excess acid.

The approval was for short-term use in these children, FDA said. The most common side effects in children were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness, the agency said.

Nexium information:

Nexium decreases the amount of acid produced in the stomach.

Nexium is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Nexium is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid),

Nexium may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Nexium may also be used for purposes other than those listed in this medication guide.

Important information about Nexium
Do not use Nexium if you are allergic to esomeprazole or to any other benzimidazole medication such as albendazole (Albenza), or mebendazole (Vermox). Before taking Nexium, tell your doctor if you have ever had liver disease or any type of heart disease. You may need a dose adjustment or special tests during treatment.

Some conditions are treated with a combination of Nexium and antibiotics. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.
Take Nexium for the entire length of time prescribed by your doctor. Your symptoms may get better before your treatment is completed. Do not crush, break, or open a delayed-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Nexium side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Indian generic cancer drugs for poor countires. Will poor have a chance?

Thursday, February 28th, 2008

Indian generic drugsA drugs firm asked Indian officials for permission Thursday to make cheaper generic copies of cancer drugs for export to poor countries in a case watched closely by global pharmaceutical giants.

Indian firm Natco Pharmaceuticals made the plea for the country’s first so-called “compulsory licence” to the patent office as it bids to make generic copies of Pfizer’s Sutent and Roche’s Tarceva cancer drugs.

“This is the first case in India. A compulsory licence will allow companies like ours to manufacture and export drugs to least developing countries,” said M. Adinarayana, the secretary of Natco Pharmaceuticals, as the hearings began.

The global drugs patent system allows countries to make cheaper generic copies of patented drugs in certain situations, such as public health emergencies, under compulsory licences.

Experts said Natco’s request for permission to make and export copies of Sutent and Tarceva to Nepal tested those regulations, amid a wider debate about whether poor countries have enough access to key but often pricey medicines.

Tarceva was granted a patent in India in 2007 following a new patent law passed in 2005, which brought the world’s largest maker of generic drugs in line with World Trade Organisation guidelines on intellectual property.

The laxer rules before 2005 had encouraged generic drugs manufacture in India, which campaigners had welcomed as good for the poor.

Compulsory licences have been granted since 2005, but so far none have been issued in India, making Hyderabad-based Natco’s plea a potentially landmark case.

Canada allowed a generic copy of a patented AIDS drugs to be exported to Rwanda in October. Thailand also issued domestic compulsory licences last year, but was criticised over claims it was not responding to a public health emergency.

An Indian Patent Office official, who declined to be named, said the hearing had started over the Roche case and that the Pfizer case would be held Friday. He expected representatives from Roche and Pfizer to attend.

Roche or Pfizer did not immediately respond to emailed requests for comment.

Many Indian activists have complained that the cost of patented drugs is too high and that provision should be made to allow generic drugs to be supplied to the country’s legion of poor.

“If compulsory licensing is not resorted to, 98 percent of India’s population will not be able to afford any of the patented drugs,” said Y.K. Sapru, the president of the non-profit Cancer Patients Aid Association.

But pharmaceutical giants often argue protecting patents are crucial to stimulating the research and development of new drugs.

Industry groups object that if Natco is granted a compulsory licence for Nepal, then it could lead other Indian firms to push for more sales of generic drugs domestically.

Natco has reportedly offered Roche a five percent royalty on generic versions of Tarceva exported to Nepal, one of the world’s poorest nations. The Indian firm stopped sales of an earlier generic copy of Tarceva after Roche won its 2007 patent.

But Indian firm Cipla, based in the financial capital Mumbai, started making a generic version of Tarceva a few months ago. Roche has filed a court case to halt further domestic sales by the firm.

One tablet of Tarceva, which fights lung cancer, costs about 4,800 rupees (120 dollars) in India, where tens of thousands of people need the medicine. Cipla’s generic copy sells for nearly one-third that price.

The cost difference is crucial for poor people, a Medecins Sans Frontieres official said.

“India is the only source for generic drugs for developing countries. It has the capacity to manufacture and has many generic producers,” said Leena Menghaney, a campaigner for the group in India.

India Restricts Generic Drugs

On spring 2005, India’s parliament voted to restrict production of low-cost generic medicines. Because India is the primary supplier of inexpensive drugs to the developing world, particularly antibiotics, cancer therapy, and AIDS drugs, the bill may choke off a vital supply of medicines to the global poor.

Under India’s 1970 Patent Act, Indian companies have been allowed to produce cheaper versions of a drug as long as they used a different manufacturing process. Competition from Indian generics has slashed the price of some drugs by almost 98 percent. In Africa, Indian generics have reduced the cost of AIDS drugs from $15,000 to $200 per patient per year. Indian companies also combined a cocktail of medicines into one simple pill. Aidsmap, a UK based information resource for AIDS patients and caregivers, estimates that half of all AIDS patients in the Third World rely on Indian generics.

The bill will change Indian patent law to be more like laws in the West. Patents will be granted to products instead of processes, and companies will maintain exclusive rights to any new drug for 20 years. The change has been anticipated since 1995, when India joined the WTO on the condition that it agree to eliminate process patents by January 1, 2005.

The new bill still must be signed by the president to go into effect. The president was the original sponsor of the bill, so Indian and international officials expect the bill to become law soon.

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Galvus (vildagliptin) improves glucose control

Thursday, February 21st, 2008

GalvusFor people with type 2 diabetes and moderately elevated blood glucose levels, the medication vildagliptin, sold under the brand name Galvus, can produce long-term improvements in the functioning of the insulin-secreting beta cells in the pancreas along with better glucose control, researchers report.

“Improvement of glucose control, which was a known fact for vildagliptin, is paralleled, and likely caused, by an improvement of beta-cell function,” Dr. Andrea Mari told Reuters Health.

Mari, from the National Research Council, Padova, Italy, and colleagues put 306 patients with type 2 diabetes on vildagliptin or an inactive placebo for a year. The participants had an A1C in the range of 6.2 percent to 7.5 percent, indicating only mild hyperglycemia.

Vildagliptin significantly increased the secretion rate of insulin by 17 percent compared to placebo, the investigators report in the Journal of Clinical Endocrinology & Metabolism.

The spike in glucose levels after a meal improved for patients on vildagliptin treatment but worsened somewhat for those given placebo, as did A1C levels, the researchers found.

The improvements with vildagliptin were fully apparent within 24 weeks of treatment, the investigators say, but none of the effects on beta-cell function remained after 4 weeks once the medication was stopped.

Because of this, Mari’s team concludes that longer studies are needed to see if vildagliptin modifies the progression of type 2 diabetes.

About Galvus

In clinical studies, Galvus has demonstrated significant reductions in blood sugar for one year. Galvus is suitable for once-daily dosing and has been evaluated both as monotherapy and in combination with other anti-diabetes agents. Galvus was not associated with overall weight gain, a key benefit for people with diabetes who struggle to keep their weight under control. The overall incidence of side effects with Galvus including hypoglycemia (excessively low blood sugar) and edema (fluid retention) was similar to placebo. Galvus lowers blood sugar by targeting islet dysfunction, i.e., it improves the ability of the islet’s alpha- and beta-cells to appropriately sense and respond to sugar in the blood.

New drug can help alcoholics

Saturday, February 16th, 2008

New DrugA new drug can help alcoholics overcome their addiction by reducing stress-induced cravings, a study has found.

There is already a drug on the market, Revia, which treats alcoholism by reducing the body’s ability to enjoy its effects.

This new drug cuts cravings by taking the edge off of stressful situations which might push recovering alcoholics to pick up the bottle again.

Behavioral stress is a major factor in extending the “vicious cycle” of alcoholism, said lead author Markus Heilig, clinical director of the National Institute on Alcohol Abuse and Alcoholism.

That’s because alcohol deprivation causes depression and increased sensitivity to stressful situations such as an argument with a spouse or tension at work.

“Alcohol is a particularly nasty drug because it actually makes you feel better, but it pushes you to feel worse once you’re without alcohol,” he told AFP.

The drug Heilig and his team tested targets an area of the brain, the neurokinin 1 receptor, which mediates responses to behavioral stress. It had previously been shown to reduce social anxiety but did not enter the market because results were inconsistent.

Helig and his team first tested its effectiveness on mice and then on a group of 50 alcoholics with anxiety problems who had been through detox and remained hospitalized for the four weeks of the trial.

Half were given a placebo and the other half were given the drug.

Cravings declined over time for all patients in the protected inpatient environment and were minimal in the majority of patients by the end of the study period.

However, those who had been drug showed a more marked improvement in the severity of their cravings when measured by self-reporting questionnaires, the assessment of their clinicians, and tests where they were exposed to socially stressful situations and then told to touch a bottle and smell their favorite alcohol.

Interestingly, there was no impact on anxious or depressive psychopathology which suggests that “the improvements observed might be specific for brain processes related to alcoholism,” the study published online in Science Express concluded.

The drug also led to increased brain responses to positive imagery and lessened responses to negative imagery, something which a recent study showed predicts less alcohol consumption over the next six months, tests using MRI mapping showed.

The next step is larger clinical trials to see if the drug can be of assistance to alcoholics who do not suffer from anxiety problems.

New Drug Suspected Capable of Treating Alcoholism

A study revealed that an existing pill might in aid in the curbing of a person’s appetite for alcohol, simply by reducing the cravings caused by stress.

The new drug reportedly worked by controlling the results of stress, as behavioral stress was a major contributor to the “vicious cycle” of alcoholism.

Study author Markus Heilig of the National Institute on Alcohol Abuse explained that depriving a person of alcohol would lead to depression and increased chances of succumbing to stress.

“Alcohol is a particularly nasty drug because it actually makes you feel better,” Heilig explained, as quoted by AFP, “but it pushes you to feel worse once you’re without alcohol.”

He continued that the drug would control a person’s responses to these effects of stress by targeting a particular part of the brain responsible for the reactions to stressful situations.

Pooling together a total of 50 recovering alcoholics, scientists gave the drug to 25 of them, and placebo pills to the other half.

Their experiment resulted in a 50 percent cut in the craving for alcohol for those who had been given the drug.

Heilig, a director at the National Institute on Alcohol Abuse and Alcoholism, noted that while other studies regarding alcoholism aimed to reduce the pleasure derived from alcohol, their study attempted to reduce the effects of the actual causes of alcoholism.

“It’s a fairly new approach to treating alcoholism treatment,” Heilig said, as quoted by ABC News. “We’re really trying to open up a new category of treatments that would help most people.”

The study received commendations from other scientists, calling it a significant discovery.

“This is a potentially important finding which indicates a novel mechanism for reducing craving in individuals who drink to reduce high anxiety,” said Boris Tabakoff, a professor and director at the University of Colorado and Denver.

Stress-Related Drug May Cut Alcoholics’ Cravings

New Research May Pave Way for New Alcoholism Treatment Therapies

A drug known to inhibit the stress response in the brain may also be a potential weapon against alcohol addiction.

So suggests a small study on recovering alcoholics published in the journal Science.

Researchers with the National Institutes of Health already knew that the drug in question neutralizes the action of a protein called NK1R (short for neurokinin-1 receptor), which is involved in the stress response in the brain. The first hint that the drug might be useful in cutting alcohol cravings surfaced when the investigators noticed that mice who didn’t have NK1R seemed to have less desire to consume alcohol.

To test their suspicions, the scientists gave the NK1R-blocking drug to 25 recovering alcoholics, while giving 25 others an ineffective placebo treatment. They found that those who received the drug reported about 50 percent fewer alcohol cravings.

Lead study investigator Dr. Markus Heilig, clinical director of the NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA), says standard drug treatments to help curb drinking urges worked by reducing the pleasure that alcoholics get from drinking. This drug takes a different approach — reducing the anxiety that leads many alcoholics to reach for the bottle in the first place.

“It’s a fairly new approach to treating alcoholism treatment,” Heilig says. “We’re really trying to open up a new category of treatments that would help most people.”

Alcoholism experts not directly involved with the study say the finding offers tantalizing clues for new treatment — as well as hints to the connection between anxiety and drinking urges.

“This is a potentially important finding which indicates a novel mechanism for reducing craving in individuals who drink to reduce high anxiety,” says Boris Tabakoff, professor and chairman of pharmacology at the University of Colorado at Denver.

But even if the findings eventually lead to an effective drug treatment option for alcoholism, some experts say, there is no therapy yet that provides a sure-fire, one-size-fits-all solution to alcohol cravings.

“It may be that this medication would help alcoholics who drink when stressed,” says Dr. Charles O’Brien, vice chair of psychiatry and director of the Treatment Research Center for the University of Pennsylvania Health System. “It is wrong to think of all alcoholics as alike.”

A New Hope for Alcoholics?

Current drug treatments for alcoholism include naltrexone and disulfiram. And it has been shown that these medications offer help for some alcoholics. But Tabakoff says more options are needed.

“The current treatments, although producing statistically significant benefit, are still of modest utility,” Tabakoff says. “New approaches need to be introduced and tested. This represents one such novel treatment that seems to be particularly effective in reducing various measurements of craving.”

The need for another option in drug-based alcoholism treatment is underscored by the fact that the drug treatments that currently exist are each most effective for the relatively small subset of alcoholics who seem to be genetically predisposed to get an extra addictive kick from alcohol.

“Generally, these sorts of new drugs may help 20 percent of alcoholics or addicts initially quit drug use, though I am not sure they would work that well on maintaining abstinence,” says Steve Sussman, professor of preventive medicine and psychology at the University of Southern California.

“While this drug may be of assistance to the extreme users, I wonder about how well it would help the majority.”

Further Study Needed

Despite the apparent success in the human part of the trial, more research will be needed before such a treatment can be considered reliable and safe. For example, the possible interaction effects of the drug with alcohol, just in case users fall off the wagon, must be determined.

And since the new study involved only patients who were under hospital care, it remains to be seen how effective the drug could be in a real-world setting, where temptations for alcoholics abound.

Heilig says additional, broader trials are currently in the works. But even at this early stage, alcoholism experts say it’s possible that the most recent findings may be a sign that, at least for some alcoholics, more help could be on the way.

“The more types of treatment modalities available, the more people with addiction problems can be helped,” Sussman says.

Tabakoff agrees. “All of medicine is moving more and more towards personalized treatments that target subgroups of patients, and I believe this report is one example of that trend,” he says. “This may be an excellent option for a sub-group of alcoholics who also suffer symptoms of anxiety. Neither naltrexone nor disulfiram are focused on these subjects.”

Salsalate may be helpful for young obese adults

Friday, February 15th, 2008

SalsalateA drug approved for the treatment of arthritis may have a role in reducing the risk of diabetes and heart trouble developing in young obese individuals, Harvard researchers report.

Compared with an inactive placebo, the anti-inflammatory drug salsalate reduced glucose levels by an average of 13 percent in 20 non-diabetic adults no older than 30 years of age with a body mass index (BMI) of at least 30 (classified as obese).

For the study, Dr. Allison B. Goldfine of the Joslin Diabetes Center in Boston and colleagues randomly assigned the participants to take 4 milligrams of salsalate daily in two divided doses, or placebo, for 4 weeks.

As well as reducing fasting glucose levels, salsalate decreased the glycemic response after an oral glucose tolerance test, improved insulin sensitivity and curbed markers of inflammation, the researchers report in the medical journal Diabetes Care.

“This proof-of-principle study demonstrates that salsalate reduces glycemia and may improve inflammatory cardiovascular risk indexes in overweight individuals,” Goldfine and colleagues conclude. They say the findings support the idea of targeting inflammation to help prevent diabetes.

“Salsalate is marketed in the United States for the treatment of arthritic pain. It is not approved for use in obesity,” Goldfine emphasized in an interview with Reuters Health.

“The drug has a good safety profile in people with arthritis. We are examining the safety profile specifically in people with this different cluster of disease,” she continued.

Several clinical trials with salsalate are ongoing. “If it is efficacious to treat or prevent diabetes, and/or cardiovascular disease, the health economic implications are exciting,” Goldfine noted, “as the product is inexpensive to manufacture and generic, which is important as the number of persons with these health issues is large.”

Salsalate Drug Information

Generic Name: salsalate
Brand Names: Disalcid, Salsitab

What is salsalate?

Salsalate is in a class of drugs called salicylates. It works by reducing substances in the body that cause pain and inflammation.

Salsalate is used to reduce pain and inflammation caused by conditions such as rheumatoid arthritis, osteoarthritis, and related rheumatic conditions.

Salsalate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about salsalate?

Take salsalate with food, milk, or an antacid to lessen stomach upset, unless you are taking any enteric coated tablet. Do not break, chew, or crush the enteric-coated tablets. Swallow them whole.

Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate damage to the stomach.

Avoid alcohol during treatment with salsalate. Together, alcohol and salsalate may increase the risk of bleeding in the stomach.

What should I discuss with my healthcare provider before taking salsalate?

Before taking this medication, tell your doctor if you

  • have an allergy to aspirin or any other NSAIDs,
  • have an ulcer or bleeding in your stomach,
  • drink more than three alcoholic beverages a day,
  • have liver or kidney disease,
  • have a coagulation (bleeding) disorder,
  • have congestive heart failure,
  • have fluid retention,
  • have heart disease, or
  • have high blood pressure.

You may not be able to take salsalate, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Salsalate is in the FDA pregnancy category C. This means that it is not known whether salsalate will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether salsalate passes into breast milk. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby. Do not use salsalate to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 18 years of age, salsalate may increase the risk of Reye’s syndrome, a rare but often fatal condition.

How should I take salsalate?

Take salsalate exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Take salsalate with milk, food, or an antacid to lessen stomach upset.

Do not take salsalate more often than every 4 hours, and do not take more than is recommended. If your condition does not improve within 3 to 4 days, seek medical attention.

Be aware of the salicylate (aspirin) content of other over-the-counter and prescription products. Care should be taken to avoid taking more than the recommended amount of salicylate per dose or per day.
Store salsalate at room temperature away from moisture and heat.

What should I avoid while taking salsalate?

Be aware of the salicylate (aspirin) content of other over-the-counter and prescription products. Care should be taken to avoid taking more than the recommended amount of salicylate per dose or per day.
Avoid prolonged exposure to sunlight. Salsalate may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Avoid alcohol during treatment with salsalate. Together, alcohol and salsalate may increase the risk of bleeding in the stomach.

Salsalate side effects

Stop taking salsalate and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • black, bloody, or tarry stools;
  • nausea, vomiting, or abdominal pain;
  • uncontrolled fever;
  • blood in urine or vomit;
  • decreased hearing or ringing in the ears;
  • seizures; or
  • dizziness, confusion, or hallucinations.

If you experience any of the following less serious side effects, notify your doctor:

  • heartburn or indigestion,
  • faint ringing in the ears,
  • drowsiness, or
  • headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect salsalate?

Do not take salsalate without first talking to your doctor if you are taking any of the following medicines:

  • an anticoagulant such as warfarin (Coumadin), heparin, enoxaparin (Lovenox), dalteparin (Fragmin), danaparoid (Orgaran), ardeparin (Normiflo), or tinzaparin (Innohep);
  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or
  • another salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others) or choline salicylate and/or magnesium salicylate (Magan, Doan’s, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal).

You may not be able to take salsalate, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with salsalate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Anti-wrinkle drugs Botox and Myobloc may be dangerous!

Tuesday, February 12th, 2008

Anti-wrinkleThe popular anti-wrinkle drug Botox and a competitor have been linked to dangerous botulism symptoms in some users, cases so bad that a few children given the drugs for muscle spasms have died, the government warned Friday.

The Food and Drug Administration’s warning includes both Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc, drugs that all use botulinum toxin to block nerve impulses, causing them to relax.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect, the FDA said.

Botox is best known for minimizing wrinkles by paralyzing facial muscles — but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.

The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have.

However, the FDA warned that it also is probing reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.

The FDA wouldn’t say exactly how many reports it is probing.

“We’re not talking hundreds. It’s a relative handful,” said Dr. Russell Katz, FDA’s neurology chief.

But the agency warned that patients receiving a botulinum toxin injection for any reason — cosmetic or medical — should be told to seek immediate care if they suffer symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up their head.

“I think people should be aware there’s a potential for this to happen,” Katz said. “People should be on the lookout for it.”

Friday’s warning came two weeks after the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings to users of Botox and Myobloc — citing 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.

Nor is it the first warning. The drugs’ labels do warn about the potential for botulinum toxin to spread beyond the injection site and occasionally kill, but the warnings link that side effect to patients with certain neuromuscular diseases, such as myasthenia gravis.

That’s what’s different about these latest cases, said FDA’s Katz: The botulism toxin seems to be harming people who don’t have that particular risk factor. (Cerebral palsy involves a brain injury, not a disease.)

Still, the FDA cautioned that its investigation is in the early stages. It has asked Botox maker Allergan Inc. and Myobloc maker Solstice Neurosciences Inc. to provide additional safety records.

Allergan spokeswoman Caroline Van Hove said children with cerebral palsy receive far larger doses injected into their leg muscles than the doses given adults seeking wrinkle care.

In a statement, Solstice said it supports FDA’s probe but stressed that the agency hasn’t concluded the drug poses any new risk.

While the FDA said the problems may be related to overdoses, it also has reports of side effects with a variety of doses.

Public Citizen’s Dr. Sidney Wolfe criticized FDA’s warning as falling short. He asked that the agency order a black-box warning, the FDA’s strongest type, be put on the drugs’ labels and require that every patient receive a pamphlet outlining the risk before each injection.

“Every doctor needs to notified about this, every patient needs to be notified,” Wolfe said. “Children are showing the way, unfortunately some dead children.”

He said drug regulators in Britain and Germany last year required that sterner warnings be sent to every doctor in those countries.

Do anti-wrinkle creams work?

Anti-wrinkle creams could help reduce the appearance of aging. Generally, these creams are not permanent wrinkle removers, but either help remove the dead outer layer of skin or hydrate the skin and plump it up, giving the appearance of removing wrinkles. Some results can be seen after about 30 days. But, once you stop using the product, the wrinkles return, so ongoing product use can become expensive depending on which cream you buy. In addition, the effectiveness of particular brands have not been scientifically studied and published in medical journals.

Given the limitations as to their success, here are some recommended products that have been reviewed:

1. Products with Vitamins C & E: The American Academy of Dermatology, published a paper, “Facing the Age Old Question…How to Turn Back the Hands of Time.” Dermatologist, Arielle N.B. Kauvar, recommended “over-the-counter topical products with ingredients such as the anti-oxidants vitamins C & E.” However, Dr. Kauvar did not specify any particular brand.

2. Products with AHA (alpha hydroxy acid): According to Dr. Kauvar, products with alpha hydroxy acid (AHA) can “help remove the dead outer layers of skin, leaving the face with a fresh, younger appearance. AHAs are particularly beneficial for wrinkles around the mouth and eyes.”

Dr. Kauvar did not recommend any particular brand, and pointed out that the most important way to prevent aging skin is to protect it with sunscreen that blocks both UVA and UVB rays and has an SPF (Sun Protection Factor) of 15 or higher. According to the American Academy of Dermatology, sun exposure is the number 1 cause of aging skin.

3. Avotone and Hydroderm: A website that claims to have examined over 17 different wrinkle treatment products ranked the two most effective. Avotone was ranked #1, and Hydroderm was #2. Avotone uses acetyl hexapeptide in their cream and costs about $90 for 1 oz. Hydroderm’s ingredients include collagen and costs about $80 for 1 oz.

4. Prescriptives Intensive Rebuilding Moisturizer: The Oprah Winfrey Show featured a segment on anti-aging. Guest dermatologist, Dr. Karyn Grossman, recommended Prescriptives Intensive Rebuilding Moisturizer, a product that she helped develop. Dr. Grossman says, “the progressive build and fill technology of the product works within the skin to strengthen, firm and lift while it also works on the outer layer of the skin to decrease the appearance of surface line and wrinkles.”

5. Neutrogena Healthy Skin Anti-Wrinkle Cream with SPF 15: Neutrogena had high ratings from consumers and is also recommended by a website that claims to review the reviews at consumersearch.com. Neutrogena’s product contains Retinol and a Sun Protection Factor, SPF 15. The cost is about $10 for a 1 oz. tube which is considerably less expensive than the other products listed above.

You could try a less expensive anti-wrinkle cream like Neutrogena rather than spend a lot of money on expensive products whose effectiveness has not been substantiated by scientific studies.

It’s best to prevent aging of the skin by having a healthy lifestyle and protect the skin from the sun. Below are 12 ways below to help prevent wrinkles.

Giving pain medications to children

Friday, February 8th, 2008

PainkillersGiving your child medications, even over-the-counter medicines, should always be carefully monitored by your doctor.

The American Academy of Family Physicians offers these suggestions before you give any pain medication to your child:

  • If a person younger than age 18 has the flu or chickenpox, never give the person aspirin, which could lead to a rare but deadly condition called Reye’s Syndrome.
  • Acetaminophen (the active ingredient in Tylenol) is a generally safe painkiller for young children.
  • Be careful about giving ibuprofen to children who are allergic to aspirin, as they may also be allergic to ibuprofen.
  • Pain relievers may be dangerous for children with asthma, so don’t administer them without a doctor’s consent.
  • Be careful not to give your child too much of the same medication. Sometimes the same active ingredient can be found in more than one medication.

Pain Medication in Young Children: How Are We Doing?

Not very well, especially for children younger than 2 years.

Doctors are known to do a poor job of treating pain. How do we do in treating pain in preverbal and very young children? To answer this question, these authors performed a retrospective chart review of patients 6 months to 10 years old who presented to a pediatric emergency department between 1999 and 2000 with isolated long-bone fractures or second- or third-degree burns.

Patients were excluded if they had closed head injury, chest or abdominal trauma, or a history of developmental delay or other neurologic impairment; 180 children were enrolled. The use of analgesics was assessed in 2 age groups: very young (6 to 24 months) and school-aged (6 to 10 years) children. More very young children than school-aged children did not receive analgesic agents (64.6% vs. 47.6%). When analgesics were used, very young patients were less likely to receive opioids (16.7% vs. 44.0%, respectively) and more likely to receive over-the-counter products (18.8% vs. 8.3%, respectively). Injury patterns differed significantly in the 2 age groups: Second-degree burns were more common in the very young group, and displaced fractures were more common in the school-aged group. Among children with nondisplaced fractures and among those with third-degree burns, there was no difference in analgesic treatment between the very young and school-aged groups.

Pain Medications

Over-the-Counter Pain Relievers

Over-the-counter (OTC) pain relievers include:

  • Acetaminophen (Tylenol, Aspirin Free Excedrin)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs; aspirin, Motrin, Aleve and Orudis KT)
  • Topical Corticosteroids (Cortaid and Cortizone)

Both acetaminophen and NSAIDs reduce fever and relieve pain caused by muscle aches and stiffness, but only NSAIDs can also reduce inflammation (swelling and irritation). Acetaminophen and NSAIDs also work differently. NSAIDs relieve pain by reducing the production of prostaglandins, which are hormone-like substances that cause pain. Acetaminophen works on the parts of the brain that receive the “pain messages.” NSAIDs are also available in a prescription strength that can be prescribed by your physician.

Topical pain relievers are also available without a doctor’s prescription. These products include creams, lotions, or sprays that are applied to the skin in order to relieve pain from sore muscles and arthritis. Some examples of topical pain relievers include Aspercreme, Ben-Gay, Icy Hot and Capzasin-P. Corticosteroid creams are also available.

Prescription Pain Relievers

Prescription pain relievers include:

  • Corticosteroids
  • Opioids
  • Antidepressants
  • Anticonvulsants (antiseizure medications)

What Are Corticosteroids?

Prescription corticosteroids provide relief for inflamed areas of the body by easing swelling, redness, itching and allergic reactions. Corticosteroids can be used to treat allergies, asthma and arthritis. When used to control pain they are generally given in the form of pills or injections. Examples include: Deltasone, Hydeltrasol and Solu-Medrol.

Prescription corticosteroids are strong medicines and may have serious side effects, including:

  • Weight gain
  • Upset stomach
  • Headache
  • Mood changes
  • Trouble sleeping
  • Weakened immune system

To minimize these potential side effects, corticosteroids are prescribed in the lowest dose possible for as short of a length of time as needed to relieve the pain. Efforts are underway to develop safer corticosteroids.

What Are Opioids?

Opioids are narcotic pain medications that contain natural, synthetic or semi-synthetic opiates. Opioids are often used for acute pain, such as short-term pain after surgery. Some examples of opioids include:

  • Morphine
  • Fentanyl
  • Oxycodone
  • Codeine

Opioids are effective for severe pain and do not cause bleeding in the stomach or other parts of the body as can other types of pain relievers. It is rare for people to become addicted to opioids if the drugs are used to treat pain for a short period of time.

Side effects of opioids may include:

  • Drowsiness
  • Nausea
  • Constipation
  • Itching
  • Breathing problems
  • Addiction

What Are Antidepressants?

Antidepressants are drugs that can treat pain and/or emotional conditions by adjusting levels of neurotransmitters (natural chemicals) in the brain. These medications can increase the availability of the body’s signals for well-being and relaxation, enabling pain control for people with chronic pain conditions that do not completely respond to usual treatments.

Chronic pain conditions treated by low-dose antidepressants include some types of headaches (like migraines) and menstrual pain. Some antidepressant medications include:

  • Selective Serotonin Reuptake Inhibitors (SSRIs) such as Celexa, Prozac, Paxil, and Zoloft
  • Tricyclic antidepressants such as Elavil, Norpramin Sinequan, Tofranil, and Pamelor
  • Selective Serotonin and Norepinephrine Reuptake Inhibitors (SSNRIs) such as Effexor and Cymbalta

These drugs require a steady dose of the medicine build up in the body over a period of time to work. The doses needed to treat pain are often lower than those needed to treat depression.

In general, antidepressants have fewer long-term side effects than frequent, ongoing use of other pain medicines. Generally, SSRIs and SSNRIs have fewer side effects than tricyclic antidepressants. The most common side effects with antidepressants include:

  • Blurry vision
  • Constipation
  • Difficulty urinating
  • Dry mouth
  • Fatigue
  • Nausea
  • Headache

What Are Anticonvulsants?

Anticonvulsants are drugs typically used to treat seizure disorders. Some of these medications are shown to be effective in treating pain as well. The exact way in which these medicines control pain is unclear but it is thought that they minimize the effects of nerves that cause pain. Some examples include Tegretol, Neurontin and Lyrica.

In general they are well tolerated. The most common side effects include:

  • Drowsiness
  • Dizziness
  • Fatigue
  • Nausea

Other Pain Treatments

Another means of topical pain relief comes in the form of a Lidoderm patch, which is a prescription medication.

If your pain is not relieved by the usual treatments, your doctor may refer you to a pain management specialist. Doctors who specialize in pain management may try other treatments such as certain types of physical therapy or other kinds of medicine. They may also recommend TENS, a procedure that uses patches placed on the skin to send signals that stop pain.

Patient-controlled analgesia (PCA) is a method of pain control that allows the patient to control the amount of pain medication administered. This is often used in the hospital to treat pain. By pushing a button on a computerized pump, the patient receives a pre-measured dose of pain medicine. The pump is connected to a small tube that allows medicine to be injected intravenously (into a vein), subcutaneously (just under the skin), or into the spinal area.

Blood pressure drugs reduce Parkinson’s risk

Thursday, February 7th, 2008

Blood pressure drugsPeople taking a certain type of blood pressure medication called calcium channel blockers may also be lowering their risk of getting Parkinson’s disease, according to a study released Wednesday.

A study by Swiss researchers found that people who had been taking a calcium channel blocker medication for an extended period of time had a 23 percent lower risk of developing the incurable neurological disease than people not on this type of drug.

The researchers also assessed several other classes of blood pressure medications, such as ACE inhibitors, AT II antagonists and beta blockers, but none of those appeared to offer the protective effect of calcium channel blockers.

“Long-term use of calcium channel blockers was associated with a reduced risk of developing Parkinson’s disease, while no such association was seen for other high blood pressure medications,” said Christoph Meier, lead author of the paper and a researcher at University Hospital Basel in Switzerland.

Meier and colleagues studied more than 7,000 men and women from the United Kingdom over the age of 40 for the study, but they did not investigate the mechanism by which the drugs lowered the risk of Parkinson’s.

Calcium channel blockers lower blood pressure by preventing calcium from entering the cells of the heart and blood vessels. The net result is that they cause blood vessels to dilate or expand, and they lead to less contraction of the heart muscle.

The class includes drugs such as Dilacor, Adalat, Cardazem, Procardia and Covera.

Parkinson’s is a chronic and progressive disorder that typically afflicts people over the age of 60. The illness stems from the loss or destruction of brain cells that produce the neurotransmitter dopamine, leading to problems with motor control.

Patients typically suffer from tremors and shakes, impaired balance and coordination and also stiffness or rigidity in the limbs or trunk.

High blood pressure medication offers reduced Parkinson’s risk

Calcium channel blockers that are used to treat high blood pressure may cut the risk of Parkinsons disease as well, say researchers.

The researchers say that their findings are based on a study of 7,374 men and women over age 40.

Christoph R. Meier of the University Hospital Basel in Switzerland has revealed half of the subjects had Parkinsons disease, while half were non-sufferers.

The studys author also revealed that nearly half of the participants in both groups used high blood pressure medications like calcium channel blockers, ACE inhibitors, AT II antagonists, and beta blockers.

It was found that people who were currently long-term users of calcium channel blockers to treat high blood pressure lowered their risk of Parkinsons disease by 23 per cent as compared to those who did not take the drugs.

No such effect was found among people taking ACE inhibitors, AT II antagonists and beta blockers.

Long-term use of calcium channel blockers was associated with a reduced risk of developing Parkinsons disease while no such association was seen for other high blood pressure medicines, said Meier.

Meier says that more research is needed to determine why calcium channel blockers appear to offer a reduced risk of Parkinsons disease, while the other high blood pressure medications do not.