Calcium Supplements Increase Heart Attack Risks

Although millions of people take calcium supplements to boost bone health and ward off osteoporosis, New Zealand researchers say the supplements have little effect on bone strength and contribute to a small increase in the risk for heart attack among older people.

Rather than relying on calcium supplements, the researchers suggest that people get their required calcium, if possible, from foods.

“When you look at major trials where people have been randomly assigned to take calcium or placebo, there is an increase in the risk of heart attack in the people who were randomly assigned to take calcium,” said the study’s lead researcher, Dr. Ian Reid, from the Department of Medicine in the Faculty of Medical and Health Sciences at the University of Auckland.

“The extent of that increased risk is enough to completely counterbalance the small beneficial effect that calcium tablets have on numbers of fractures,” he said.

Calcium from diet best

Reid was careful to note that people need calcium in their diet. “What we are saying is that calcium supplements don’t appear to be a good thing, based on the current evidence,” he explained.

The report is published online in BMJ.

The study

For the study, Reid’s team did a meta-analysis of 11 randomised, controlled trials involving 11 921 people. In other words, the researchers reviewed already published studies and teased out data on any connection between calcium supplements and heart attacks.

Their analysis found nearly a 30% increased likelihood of having a heart attack among people older than 40 who were taking calcium supplements. In addition, there was a small but statistically insignificant increase in the risk for stroke and death among those taking supplements.

The findings remained consistent even after taking into account age, gender and the type of supplement, the researchers said.

The increased risk for a heart attack was a modest one, the researchers noted.

Though a 30% increased risk is, in absolute terms, small, it still could reveal a large problem because so many people take calcium supplements, Reid said.

The findings

Earlier studies did not find a similar risk when people get calcium through eating foods rich in the mineral, which suggests that supplements may be an independent risk factor.

Moreover, noting that calcium supplements appeared to have only a minor effect on bone health and perhaps no effect in preventing fractures, the researchers suggested that their use in preventing or treating osteoporosis (thinning of the bones) should be reconsidered.

Reid speculated that calcium supplements can increase blood levels of calcium above the normal level, causing changes in blood chemistry, which could be dangerous in people at risk for heart attacks.

“We advise our patients to move away from calcium supplements and move toward eating calcium-rich food as part of a normal balanced diet and to remain physically active,” he said.

Medication vs. supplements

In addition, Reid said, people should have a bone density test to assess their risk for osteoporosis. “If their risk is high, they should consider using medications rather than calcium supplements,” he said.

He and other researchers noted that the study had certain limitations, including excluding studies in which participants took both vitamin D and calcium supplements, and added that some of the trials they reviewed did not collect data on heart problems in a standardized manner.

Dr John Cleland, from the Department of Cardiology at Castle Hill Hospital and Hull York Medical School at the University of Hull in Kingston upon Hull in the United Kingdom, who wrote an accompanying journal editorial, said that “calcium supplements probably don’t reduce fractures and certainly don’t reduce mortality and can now be considered ineffective.”

“It is not clear whether they really increase the risk of heart attacks or strokes,” he said. “However, they do appear to be a waste of time and effort, and we should probably stop using them.”

Research is needed to find treatments for osteoporosis with and without calcium and vitamin D supplements, Cleland said.

“Newer treatments and some old neglected ones, like thiazide diuretics, do reduce fractures and reduce mortality,” he said. “We don’t know whether or not you need to take calcium and vitamin D to make them work. We know supplements are a waste of time by themselves, but [whether they] act as adjuvants for effective therapy is not known.”

Break it up over the day

Duffy MacKay, vice president for scientific and regulatory affairs at the Council for Responsible Nutrition, a supplement industry lobbying group, described the conclusion by Reid’s group as weak because none of the studies used in the report were specifically designed to look at the risk for heart attack.

“I see a very strong conclusion, and I think that [it] is very overstated,” he said. “My conclusion to this is [that] here is some preliminary evidence suggesting something we need to look at with additional clinical trials.”

MacKay said he advises people to get 1 000 to 1 500 milligrams of calcium a day from dairy products and leafy green vegetables. If your diet doesn’t contain enough calcium, then the gap can be filled with a calcium supplement, he said.

For people who take calcium supplements, MacKay advises not taking the dose all at once, but breaking it up over the day so that calcium levels in the blood don’t increase beyond normal.

Calcium Supplements May Raise Risk of Heart Attack

Calcium supplements, which many people consume hoping to ward off osteoporosis, may increase the risk of heart attack by as much as 30 percent, researchers reported Friday.

These tiny tablets which carry concentrated doses of calcium were also associated with higher incidences of stroke and death, but they were not statistically significant.

The researchers advised people consuming calcium supplements to seek advice from their doctors, take more calcium-rich foods and try other interventions like exercise, not smoking and keeping a healthy weight to prevent osteoporosis.

“People regard calcium supplements as natural but they are really not natural at all,” Ian Reid, professor of medicine at the University of Auckland in New Zealand, said in a telephone interview.

Reid and colleagues in Britain and the United States conducted a meta-analysis encompassing 11 studies that tracked nearly 12,000 elderly people over four years.

Half of them were given calcium supplements and the other half placebo or dummy pills with no therapeutic content. The results were published in the British Medical Journal.
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They knew Avandia caused an increased risk of heart problems!

The pharmacy company that makes Avandia knew more than a decade ago that the blockbuster diabetes drug caused an increased risk of heart problems but covered up the information, according to a report published Tuesday in The New York Times.

In a 1999 trial pitting Avandia against its competitor, Actos, the drug company, then known as SmithKline Beecham, found that Avandia posed a heart risk, the newspaper reported.

The Times report, based on internal company documents it obtained, said that the company did not post results of its drug trial findings on its Web site or submit them to federal regulators.

According to a March 29, 2001, e-mail message the Times obtained, Dr. Martin I. Freed, a company executive, wrote about the study results: “This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.” GlaxoSmith Kline is the corporate successor to SmithKline.

The safety of Avandia (rosiglitazone) comes under U.S. government scrutiny starting Tuesday, as an advisory panel of experts begins two days of hearings.

The new information released by the Times comes after new doubts surfaced last week on a key trial that helped keep Avandia on the market.

Last Friday, a medical reviewer for the U.S. Food and Drug Administration posted remarks on the agency’s Web site suggesting that GlaxoSmithKline’s “mishandling” of trial results may have masked some cardiovascular effects of Avandia.

The official’s posting was part of a safety reassessment package prepared for the FDA’s advisory panel meeting.

At issue in the review posting were the results of the landmark RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial, which was done by Glaxo at the FDA’s request. The results, announced in June of 2009, found that Avandia raised the risk of heart failure but not to a level of statistical significance. The study also concluded that the drug did not increase the risk of cardiovascular disease or overall death.

In his posting, Thomas A. Marciniak, medical team leader of the division of cardiovascular and renal products at the FDA’s Center for Drug Control and Evaluation, said that “RECORD was inadequately designed and conducted to provide any reassurance about the [cardiovascular] safety of rosiglitazone” and that “RECORD suggests the (sic) rosiglitazone increases the risk for [heart attacks].”

Last June, Glaxo used the trial results to tout the drug’s safety.

“RECORD provides important and reassuring information about Avandia for physicians fighting diabetes,” said Dr. Ellen Strahlman, Glaxo’s chief medical officer, in a statement released at the time. “We believe that the results showed that Avandia is safe.”

On Friday, the company, in a prepared statement, said, “The RECORD study was conducted according to good clinical practices and the data are reliable. . . RECORD demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to metformin and sulfonylureas.”

But Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, said Friday, “If the data from RECORD had truly been mishandled in some way, not only is it going to pretty well be the end of Avandia in the clinical world, but it’s going to put GlaxoSmithKline under the magnifying glass in an important way for clinicians going forward. They’ll lose credibility, and that’s tough to get back.”

“There is an alternative drug out there,” Garratt added. “From the clinical side, it’s a fortunate circumstance that we find ourselves in, since we have an alternative product that seems to have [little] risk associated with it.”

Actos (pioglitazone), made by Takeda, is in the same pharmaceutical class as Avandia. Both are medications known as thiazolidinediones (TZDs), which are blood sugar-lowering drugs. Both are used by type 2 diabetics.

On Tuesday, groups including the American Diabetes Association, the American Association of Clinical Endocrinologists and The Endocrine Society issued a joint statement advising patients who are using Avandia to hold steady for now.

“Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,” the experts said. “Stopping diabetes medications can result in higher levels of blood glucose that may cause serious short-term health problems and could increase the risk of diabetes-related complications in the long term.”

They added that “until further clarification is provided by the FDA, the decision whether or not to use any medication must remain that of the treating provider in direct discussion with the individual patient.”

What is Avandia?

Avandia is an oral diabetes medicine that helps control blood sugar levels by making the cells of the body more sensitive to the action of insulin.

Avandia is for people with type 2 (non-insulin-dependent) diabetes. It is sometimes used in combination other medications, but it is not for treating type 1 diabetes. Taking Avandia with insulin or nitrates is not recommended.

Avandia may also be used for other purposes not listed in this medication guide.
Important information about Avandia
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Cancer drug cyclophosphamide activates a viral infection

The cancer drug cyclophosphamide activates a viral infection that helps anti-viral medications eliminate a virus-linked cancer, says a new study.

The drug is used to treat Burkitt lymphoma, an aggressive, fast-growing type of non-Hodgkin lymphoma that often occurs in children. In Africa, the cancer is caused by the Epstein-Barr virus (EBV), which typically remains dormant inside tumor cells.

This study of 21 patients, ages 5 to 15, who were being treated with cyclophosphamide, found that the drug triggers an active EBV infection. Increased replication of the virus in cancer cells makes the cells more susceptible to antiviral drugs, which kill cells containing the replicating virus.

The study was published in the April issue of the journal Clinical Cancer Research.

“What we have learned from this work is a potential means of capitalizing on presence of viral genomes within tumor cells to alter those tumor cells in a way that makes them more susceptible to treatment. Our findings have implications for other EBV-related malignancies that, overall, are among the most common cancers worldwide,” Dr. Margaret Gulley, a professor of pathology and laboratory medicine at the University of North Carolina at Chapel Hill School of Medicine, said in a news release.

EBV infects more than 90 percent of people worldwide and is associated with a number of diseases including lymphomas, gastric cancer, and nose and throat cancer.

The next step in this research is a clinical trial to test the use of a cancer drug and an antiviral drug simultaneously, Gulley said.

Researchers have reached a deeper understanding of how tumours actively suppress immune responses in their immediate environment, which can dampen responses to cancer vaccines. To overcome this, some therapies currently in development combine the vaccine with chemotherapies that are designed to counteract this immune suppression. For example, a Seattle-based biotechnology company called Oncothyreon has developed a cancer vaccine called Stimuvax that is administered in combination with the drug cyclophosphamide. The compound inhibits immune cells called T-regulatory cells, which block immune responses to the body’s own molecules.

Compounds that modulate the immune response could have unwanted side effects, however. A patient in a clinical trial of Stimuvax involving high doses of cyclophosphamide developed an acute inflammation of the brain, which caused the FDA to put all Stimuvax trials on hold.

A clean safety profile is crucial if cancer-vaccine developers are to improve a vaccine’s performance in clinical trials. To date, most of these trials have enrolled patients who are in the advanced stages of cancer, which may have limited the trials’ effectiveness because such individuals may not be able to mount an effective immune response. Now that such vaccines have been established as safe in phase II trials, clinicians are more willing to test them in healthier patients. An ongoing large trial of a lung cancer vaccine by London-based pharmaceutical firm GlaxoSmithKline, for example, is enrolling patients at an earlier stage of the disease.
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Naproxen, acetaminophen dull migraine pain

Naproxen, acetaminophen dull migraine painMigraine sufferers may be able to get sufficient relief without turning to prescription drugs, according to two new studies.

The studies, published in the latest issue of the journal Headache, conclude that naproxen (marketed as Aleve) and acetaminophen (Tylenol) effectively decreased or eliminated pain and reduced migraine recurrence and migraine-associated symptoms to a degree defined as a “desirable outcome” of migraine therapy by the International Headache Society.

Migraine headache affects as many as 28 million Americans and costs the U.S. economy an estimated $24 billion every year.

About three-quarters of people who suffer from migraines report more than one migraine a month. The symptoms — pain, light and noise sensitivity, nausea — can last from 4 to 72 hours and often lead to missed days from school or work.

Researchers from Thailand analyzed four well-designed previous studies of naproxen at doses of 500 to 825 milligrams for treatment of acute moderate to severe migraines involving 2,168 patients.

Led by Chuthamanee Suthisisand of Mahidol University in Bangkok, the authors concluded that naproxen effectively reduced headache intensity, pain and symptoms within 2 hours of taking it - defined by the International Headache Society as a desirable outcome.

When compared to other drugs known as triptans, naproxen did as well as the prescription drug frovatriptan (marketed as Frova) but did not offer the same clinical benefits as almotriptan (marketed as Axert) and zolmitriptan (marketed as Zomig).

However, because of side effects, not all patients can take triptans, and naproxen offers those patients a non-prescription alternative, Suthisisand told Reuters Health by email.

Still, the authors found that naproxen “appears to be inferior” to aspirin in treating migraines. Suthisisand said the science suggests 1,000 milligrams of aspirin is the best of several treatments that include naproxen and acetaminophen for acute moderate to severe migraine episodes, as long as patients can tolerate potential gastrointestinal side effects.

Although the Thai team acknowledged that the quality of studies such as theirs depends on the quality of the original studies, they said they were confident the studies they reviewed were high-quality.

In the second study, researchers from McNeil Consumer Healthcare, the makers of Tylenol, randomly assigned 378 migraine sufferers to either 1000 milligrams of Tylenol or a dummy pill.

In the 90-day trial, the researchers, led by Mary Jane Prior, found that the Tylenol group began to benefit within an hour of taking the medication. At 2 hours, 52 percent of the acetaminophen group reported that their pain was reduced to mild or no pain, compared to 32 percent of the dummy pill group.

The team also reported a benefit for severe pain sufferers, but they could not determine whether that was due to chance, given the small number of patients in the trial.

The study also found that acetaminophen offered “significantly larger” relief than placebo from nausea and noise sensitivity at 2 hours and nausea, light and noise sensitivity and functional impairment at 6 hours.

The study, the authors concluded, adds to earlier clinical evidence supporting acetaminophen’s use to treat migraine.

“When effective,” the authors wrote, “acetaminophen provides consumers with a non-prescriptive, lower cost alternative to costly prescription migraine drugs.”

Acetaminophen is not currently approved by the FDA as a migraine treatment except as part of an aspirin or aspirin and caffeine compound. McNeil Consumer Healthcare declined to say whether they were applying to the FDA for approval of acetaminophen for use in migraine.

Naproxen
Brand names: Aleve, Anaprox, Comfort Pac with Naproxen, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan, Naprosyn

What is naproxen?
Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.
Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Naproxen may also be used for other purposes not listed in this medication guide.
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Salsalate Treats Type 2 Diabetes

Salsalate Treats Type 2 DiabetesA common pain reliever may help people with type 2 diabetes control their blood sugar levels.

A preliminary study shows salsalate reduced blood sugar levels and helped with glycemic control at a variety of doses in people with type 2 diabetes. However, it also has been shown to increase protein in the urine and its long-term safety will need further investigation.

Like aspirin, salsalate is an anti-inflammatory drug derived from salicylate and is often used to treat arthritis. Researchers say the first reports of salicylate-based drugs aiding in the treatment of diabetes were published more than a century ago.

Study Shows Painkiller Salsalate May Reduce Blood Sugar Levels

More recently, inflammation has been implicated in development of the insulin resistance that leads to elevated blood sugar levels associated with type 2 diabetes. Aspirin has also been shown to lower blood sugar levels, but the high doses required are associated with a risk of bleeding, which limits its utility.

That prompted researchers to take another look at salsalate in reducing blood sugar levels. Salsalate contains the same active ingredient as aspirin but is associated with fewer side effects.

In the study, published in the Annals of Internal Medicine, researchers randomly assigned 108 people with type 2 diabetes to receive 3, 3.5, or 4 grams per day of salsalate or a placebo in addition to their current diabetes therapy for 14 weeks.

The results showed those who took salsalate at each of the dosage levels experienced a beneficial decrease in blood sugar A1c levels of 0.5% or more. Other markers of glycemic control and heart disease risk also improved in the three salsalate groups compared with the placebo group. No single dose of salsalate seemed safer or more effective than another.

Although only minor side effects of salsalate use were reported, researchers say salsalate users tended to develop more protein in their urine. Elevated protein levels in the urine may indicate negative effects on kidney function.

Due to the small size of the study and short follow-up time, researchers say it’s too soon to recommend use of salsalate for the treatment of type 2 diabetes. But the results do merit further research.

“Because of salsalate’s anti-inflammatory effects, our results suggest that inflammation plays a role in the pathogenesis of type 2 diabetes and that anti-inflammatory therapy may be useful for treating diabetes,” write researchers Allison B. Goldfine, MD, of the Joslin Diabetes Center in Boston, and colleagues. “We are conducting a larger trial involving more patients with type 2 diabetes to further establish whether a salsalate dosage of 3.5g/day provides durable and safe control of blood glucose in this population.”

Arthritis Drug May Fight Diabetes

A generic drug widely prescribed for arthritis shows promise in treating type 2 diabetes, according to U.S. researchers.

They found that salsalate — an atypical non-steroidal anti-inflammatory drug, chemically similar to aspirin but easier on the stomach — helps control glucose levels.

The finding came from a three-month clinical trial of 108 people, 18 to 75 years old, who had type 2 diabetes. Those who took salsalate, the study found, had a 0.5 percent drop in levels of hemoglobin A1C, a measure of blood glucose levels. The decrease was in the range of several recently released diabetes treatments, according to the study, led by Joslin Diabetes Center researchers.
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Breast Feeding and Medications

Breast Feeding and MedicationsJust as when they were pregnant, breast-feeding moms need to monitor the drugs they take, which could reach their infants.

The American Academy of Family Physicians offers these medication guidelines for breast-feeding mothers:

  1. If you must take medications orally, take them just after breast-feeding, to give the medications time to travel through your system.
  2. Generally, acetaminophen and NSAIDs are safe pain relievers for nursing women, but always check first with your doctor.
  3. Don’t take aspirin while breast-feeding, as it may lead to bleeding and skin rash in babies.
  4. Don’t take antihistamines long-term while breast-feeding.
  5. Carefully monitor your baby for any side effects from your medications. Be especially aware of symptoms such as trouble breathing or skin rash.

TAKING MEDICATIONS SAFELY WHILE BREASTFEEDING

Most drugs that go into your body will also go into your milk, so before you take any medication, you need to consider how it will affect your baby and whether or not it has any effects on lactation. While most medications are safe to take while breastfeeding, it’s wise to talk to your doctor or your baby’s doctor before taking anything. Here are some general guidelines.

There are three issues to consider when considering taking medication while breastfeeding:

  • Do you need the drug?
  • Will the drug affect baby?
  • Will the drug affect your ability to make milk?
  • Answering these questions should help you weigh the risks and the benefits of taking a particular medication. As you gather information about the medication, you may also want to consider whether timing the dosage can minimize baby’s exposure to the drug. If it’s absolutely necessary to avoid breastfeeding while taking a medication, consider temporary weaning pump and dump as an alternative to stopping breastfeeding entirely.

    Do you need the drug? How sick are you? Be honest. Trying to tough it out for several days may actually decrease your milk supply, and you may not be a very good mother to your baby during this time. Taking medicine may often lessen the severity and duration of your illness, and in some situations, it’s absolutely necessary. If the medication is necessary for your own well-being, usually the benefits to you–and indirectly, to baby–will outweigh the risks of baby being exposed to a small amount of the medication in your milk. (There are exceptions to this. See the drug chart for information on medications that should not be taken by breastfeeding mothers.)
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    On the other hand, if you have a minor ailment, such as a cold, consider alternatives to taking medicine. While nearly all over-the-counter cold remedies are safe to take while breastfeeding, many are only marginally effective. You may get more relief by treating your cold the old- fashioned way: steam, extra fluids, rest, and a tincture of time.

    Another question to ask is do you need this drug? Often, if a particular drug is not safe to take while breastfeeding, or if little information is available about a drug, you and your physician may decide to treat your condition with another medication that is known to be safe. If there are several different drugs that can be used to treat your illness effectively, the doctor should choose the one least likely to affect your baby and your milk production. This may mean using older drugs rather than the latest thing from the pharmaceutical company.
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    Some people don’t metabolize Plavix properly

    Salsalate Treats Type 2 DiabetesThe anti-clotting drug Plavix must now carry a “black box” warning on its label, alerting patients and doctors that some people don’t metabolize the medication properly, U.S. health officials said Friday.

    Patients with a certain genetic variation can’t convert the blood thinner into its active form, which puts them at risk for heart attack and stroke, the U.S. Food and Drug Administration warned.

    “If the patient makes less of the active form, there is less antiplatelet effect in the blood, and the patient may not receive the full benefit of Plavix treatment,” Mary Ross Southworth, FDA’s deputy director for safety in the division of cardiovascular and renal products at the Center for Drug Evaluation and Research, said during an afternoon press conference.

    These patients are called poor metabolizers, she said.

    Clopidogrel (Plavix) is generally prescribed after a heart attack, stroke or a procedure to open blocked coronary arteries. It usually makes platelets less likely to form blood clots, thus reducing the risk of heart attack, unstable angina, stroke and cardiovascular death in patients with cardiovascular disease.

    For the drug to do its work, liver enzymes, especially one called CYP2C19, must convert the drug to its active form. In patients with low levels of the enzyme, the drug may be less effective in preventing heart attack, stroke and cardiovascular death, according to the FDA.

    About 2 percent to 14 percent of people fall into this category, with the percentages varying by race. About 2 percent of whites have the variation, while 4 percent of blacks and 14 percent of Chinese people do, Southworth said.

    But patients should not stop taking Plavix without consulting their doctor, the FDA said, noting a test to assess the CYP2C19 genotype can determine if a patient is a poor metabolizer.

    In May 2009, the FDA required mention of the problem on the bottle label, but additional data from a recent study has caused the agency to call for the “black box” alert, its strongest warning.

    That study, which the FDA asked Plavix’s makers to conduct, found less antiplatelet activity in people who were poor metabolizers than in patients who had no problem converting the drug.

    However, when Plavix was given at higher-than-usual doses, the poor metabolizers showed more active drug in their blood than when they received lower doses, the researchers noted.

    Patients who cannot convert Plavix well should use another anti-clotting drug or try an alternate strategy, such as a dosage increase, the FDA advised. Anti-clotting drugs that might be substituted for Plavix include ticlopidine (Ticlid) and prasugrel (Efient), the FDA said.
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    New Anti-AIDS pill under development

    New anti-aids pillScientists are developing an anti-AIDS pill that can be taken before sex and prevent transmission of the deadly disease.

    The successful development of such a treatment would be controversial because it raises ethical questions about the circumstances in which the pill should be taken.

    Experts in the disease, which claimed two million lives last year, are involved in scientific trials on antiretroviral drugs that already used to prevent transmission of AIDS from infected mothers to their babies during birth.

    Scientists are hopeful that similar protection can be offered during sex.

    Three trials of antiretroviral drugs are underway around the world. A report published in the Lancet claims they are “showing great promise” as experts meet in Mexico City for the International Conference on AIDS.

    More research has to be done on the side-effects of the pill and the development of resistant strains of HIV before it is made available.

    Controversy is bound to arise over who should take the pill and for what reasons. Globally, use would probably have to be restricted to those at greatest risk from AIDS such as sex workers or injecting drug users.

    The pill could also have a major impact on the lifestyles at a time when experts have observed that promiscuity is on the rise.

    “The party scene involving multiple sexual partners is definitely back in London and probably in most European cities,” said Sheena MCormack, a specialist in HIV prevention and reader in clinical epidemiology at Imperial College London, said.

    “There is metrosexual mixing involving gay, bisexual and some heterosexual cases. We estimate new HIV infections in gay men are running at three per cent a year.”

    She added: “People could pop a pill on a Friday night and be covered for a whole weekend.”

    The trials involve 2,400 drug injectors in Thailand, 1,200 heterosexual men and women in Botswana and 3,000 homosexual men in America, Africa and Asia.

    Experiments on primates suggest that the drugs are effective and can prevent the disease being passed. But their success in humans has yet to be proved, the Lancet report by Nancy Padian of Women’s Global Heath Imperative, San Francisco, said.

    The trials use tenofovir, a drug currently used to treat AIDS, with a combination of other drugs.

    Tenofovir (Trade name Viread) is an anti-HIV drug approved by the FDA (In October of 2001) to be used in combination with other HIV fighting medications. Viread belongs to a new class of drugs called Nucleotide Reverse Transcriptase Inhibitors (NtRTI). These are related to Nucleoside Reverse Transcriptase Inhibitors (NRTI) like zidovudine (AZT, Retrovir). The body converts Viread into a chemical that prevent HIV from reproducing in uninfected cells, but it does not help cells that have already been infected with the virus. As people with HIV lose CD4 cells - one of the immune system’s main defenses - they become more likely to get infections and illnesses.

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    Self-Dosing Pain Medications - be careful!

    painkillersAllowing patients to control their own pain medication intravenously is four times more likely to cause the patient harm than other medications, a new study says.

    The report, published in the December issue of The Joint Commission Journal on Quality and Patient Safety, shows that most mistakes involving intravenous patient-controlled analgesia (PCA) resulted from either human error, equipment issues or communication problems that led to the patient receiving the wrong dosage or drug. PCA errors also tended to be more severe — harming patients and requiring clinical interventions — than other types of medication errors.

    “The entire PCA process is highly complex,” lead author Rodney W. Hicks, the UMC Health System Endowed Chair for Patient Safety at Texas Tech University Health Sciences Center in Lubbock, said in a news release issued by the journal’s publisher. “PCA orders must be written, reviewed, and then accurately programmed into sophisticated delivery devices for patients to be pain free. Such complexity makes PCA an error-prone process. Health care organizations should now plan to make the process safer.”

    The five-year study uncovered more than 9,500 PCA errors. Patients were harmed in 6.5 percent of these incidents, compared to 1.5 percent for general medication errors.

    In PCA, a computerized pump with a syringe of prescribed pain medication is hooked straight into a patient’s intravenous (IV) line. The patient can self-dose by pushing a button.

    Hicks and his co-authors make three recommendations to reduce future PCA errors:
    Simplify the equipment. Easier step-by-step setup instructions could cut down on programming errors by caregivers setting up the PCA machine’s dosage levels.
    Use bar codes and keep an electronic medication administration record. Making a standard practice out of independent double-checks of the PCA orders, the product, and the PCA device could help prevent giving patients’ the wrong medication.
    Design and use easy, standardized forms for PCA. Use of universal forms by pharmacists could correct communication issues in the process.

    Painkillers Linked to Increase in Overdose Deaths

    Deaths from overdoses of prescription drugs, primarily pain relievers, appear to be on the rise throughout the United States, new research suggests.

    West Virginia, in particular, has seen a large increase in such unintentional deaths, say government researchers, who have uncovered patterns of “doctor shopping” for drugs and overdosing on medications not used as prescribed.
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    Serevent and Foradil asthma drugs may be risky

    asthma drugsThe risks of two widely used asthma drugs outweigh their benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said Thursday.

    The health panel targeted GlaxoSmithKline’s Serevent and Foradil, made jointly by Novartis AG and Schering-Plough, for restrictions, but it excluded Advair, Glaxo’s biggest-selling drug in the class of medications known as long-acting beta-agonists. It also left alone a fourth such drug, AstraZeneca’s Symbicort.

    The health experts did not say that the use of Serevent and Foradil should be abandoned altogether. Instead, they said the medications’ labeling should be reworded to urge doctors to use the drugs along with an inhaled corticosteroid — as guidelines already recommend.

    That may help explain why Advair and Symbicort were spared. Serevent contains just one active ingredient, salmeterol, while Foradil contains only formoterol. Advair is a combination of both salmeterol and fluticasone (an inhaled cortocosteroid), while Symbicort contains formoterol and another steroid (budesonide). All of these drugs relax airway muscles, letting asthma patients breathe more easily.

    The controversy over these drugs has been going on for several years, with two FDA officials recently calling for banning the use of these drugs for anyone under 17. The results of studies noting a rise in asthma-related deaths by people using the medications have already resulted in a black-box warning that use could “increase the risk of asthma-related death.”

    The advisory panel voted 10 to 17 on whether the benefits of Serevent outweighed its risk as maintenance therapy for adults, and voted 6 to 21 on the same question for adolescents ages 12 to 17, Dow Jones reported. Foradil received similar votes on the same questions: 9 to 18 for adults and 6 to 21 for adults.

    The panelists were unanimous in voting that the benefits of the two drugs did not outweigh risks when used for children ages 11 and younger.

    The announcement followed a two-day meeting on the issue by the expert advisory panel. The FDA is not obligated to follow the advice of its advisory panels but usually does so.

    Speaking before Thursday’s decision, one expert said the problem is not with the drugs, but with their misuse.

    “This is an over-interpretation of the risk without adequate consideration of benefit,” said Dr. Miles Weinberger, a professor of pediatrics at the University of Iowa. “However, there has been irresponsible marketing of the products, salmeterol and formoterol, and irresponsible prescribing by many physicians.”

    “Since most patients with chronic asthma can be controlled with inhaled steroids alone, using these more expensive combination formulations as first line is inappropriate but strongly encouraged by marketing practices” of drug makers, Weinberger said.

    In the panel’s first day of hearings on Wednesday, FDA officials themselves were split over the risks of the drugs.

    One official told the panel members that more than 14,000 people may have died since 1994 after taking the drugs, while another suggested that an even greater number might have died without them, according to The New York Times.

    Last week, two FDA officials, who work in the agency’s safety division, posted an assessment on the agency Web site, saying asthma sufferers of all ages should not take the medicines. But a third FDA official concluded that Advair and Symbicort are safe for adults, but that all four drugs should no longer be used by children 17 and younger, the Times said.

    The panel was reviewing an FDA study of 110 trials that included 60,954 people and found an increase in asthma-related hospitalization, asthma-related intubation, and asthma-related death in asthmatic patients with the use of these drugs. The risk varied, however, depending on the particular drug studied.

    For example, there were 20 asthma-related deaths, 16 among people taking long-acting beta agonists compared with four patients not taking these drugs. All the deaths were in patients taking Serevent, the FDA notes.

    The increased risk wasn’t seen when a long-acting beta agonist was used along with an inhaled corticosteroid, the agency found.

    The greatest risk appears to be among children aged 4 to 11; women also appeared to be at greater risk than men.

    Weinberger thinks that long-acting beta agonists should be used only in combination with inhaled steroids.

    “All trials of the combination of long-acting beta agonists and an inhaled steroid demonstrate substantial additive effect for patients not fully controlled on the inhaled steroid alone,” Weinberger said. “The sensible approach is to use the combination products only after inadequate control is observed with an inhaled steroid alone.”

    For their part, the drugs’ manufacturers said they believe there is adequate evidence that their products are safe and effective when used properly.

    In a joint statement issued after the panel voted, Novartis and Schering-Plough said both companies “remain confident in the safety and efficacy of Foradil.” The statement added, “Novartis and Schering-Plough strongly disagree with the Joint Advisory Committees view that the benefits of Foradil do not outweigh its risks in patients using it according to current product labeling for the maintenance treatment of asthma. We believe this opinion is inconsistent with clinical evidence supporting the benefit/risk profile of Foradil in patients not adequately controlled on other asthma-controller treatments.”

    In its statement before the vote, AstraZeneca said the company “believes that Symbicort exhibits a favorable benefit-risk profile in patients 6 years of age and older. Symbicort offers an important therapeutic option for asthma patients who cannot be adequately controlled on other asthma controller medications [low- to medium-dose inhaled corticosteroids] or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.”
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