Unsafe Drugs: January 2007 Archives

Antidepressants Linked to Fracture Risk

Those who take antidepressants known as selective serotonin re-uptake inhibitors may be doubling their risk for bone fractures. SSRIs, like Paxil and Prozac, have been linked to an increased risk of fractures from falling. The drugs are commonly used to treat depression and anxiety.

Antidepressants Linked to Fracture Risk

The latest study was led by Dr. David Goltzman from the McGill Center for Bone and Periodontal Research at McGill University in Montreal and supports evidence from earlier studies. "There is good scientific evidence that serotonin is involved in bone physiology, and if you alter the system, you can get low bone density," said Goltzman. "Patients should be monitored to prevent the risk of fractures." Golzman and his team looked at 137 patients who took SSRIs. The bone density of the subjects was looked at for five years and asked whether they had suffered from fractures. Goltzman's team's data showed that patients had twice the risk of fractures.

Posted by Patricia Bowling at 01:47 PM | Permalink

FDA Considers New Standards for Birth Control Drugs

Newer birth control pills appear to be less effective at preventing pregnancy than those approved decades ago. The Food and Drug Administration says that new oral contraceptives can have up to twice the failure rate as those approved years ago, likely because drug makers have begun to use lower doses of hormones. The Food and Drug Administration will ask a panel of experts whether it should require that new contraceptive drugs meet a standard of effectiveness before they are approved.

FDA Considers New Standards For Birth Control Drugs

More than 60% of American women between the ages of 15 and 44 use some kind of contraception. A large number of these women choose birth control pills, and thus might be affected by lower efficiency rates.

Posted by Patricia Bowling at 01:33 PM | Permalink

Beta-Agonists May Cause Thousands of Asthma Deaths Each Year

Long-acting beta-agonists are a kind of medicine called bronchodilators. Bronchodilators work to open constricted airways. Serevent and Foradil are used to control moderate to severe asthma and to prevent nighttime problems. Salmeterol is one of the most commonly prescribed medications in the world. However, in recent years, numerous studies are providing evidence that regular use of beta-agonists are associated with tolerance to the drug's effects and less ability in disease control. Studies also have revealed that the risk of life threatening and fatal asthma attacks increases with use of these medications.

Beta-Agonists may cause thousands of asthma-related deaths each year

Beta-agnoists are widely used to treat Chronic Obstructive Pulmonary Disease. A study looking at patients taking beta-agonists for treatment found that respiratory deaths doubled as opposed to those not taking beta-agonists. The authors of the study estimate that salmeterol may be responsible for between 4,000 and 5,000 asthma-related deaths in the United States each year.

Posted by Patricia Bowling at 01:06 PM | Permalink

No Evidence to Support Off-Label Users of Atypical Antipsychotics

Some antipsychotic medications approved for the treatment of schizophrenia and bipolar disorder are being prescribed to millions of American for depression, dementia, and other psychiatric disorders even though there is no evidence that such off-label treatment is effective. A new study by HHS's Agency for Healthcare Research and Quality compared the effectiveness of atypical antipsychotics with more tradition treatments and found an "urgent need" for more research into new treatments for dementia patients who have severe agitation.

No Evidence To Support Many Off-label Uses Of Atypical Antipsychotics

Atypical antipsychotics are second-generation medicines intended to cause fewer neurological complications than conventional antipsychotics. They include Abilify, Zyprexa, Seroquel, Risperdal, and Geodon. Review authors say that the potential benefits and risks of the medications found strong evidence that atypical antipsychotics can increase chances of adverse effects. Some of the drugs increase risk of strokes, tremors, weight gain, sedation, and gastrointestinal problems. "This report emphasizes the importance of understanding the risks and benefits of different medicines," said AHRQ Director Carolyn M. Clancy, M.D. "Caution is necessary in the off-label use of atypical antipsychotics, especially when used in the elderly and when the evidence for effectiveness is not good.''

Posted by Patricia Bowling at 11:02 AM | Permalink

Court Will Review Vioxx Health-Test Suit

A New Jersey appeals court has echoed the sentiment that Merck may have to pay for an unknown number of Vioxx users to undergo tests for undetected heart attacks. A three-judge panel decided that a state court must reconsider a proposed class-action lawsuit; this could decide whether Merck must pay for medical monitoring for patients who took Vioxx but have not yet been diagnosed with any heart problems.

Court must review Vioxx health-test suit

The decision would apply to anyone in the United States who took Vioxx for at least six consecutive weeks. The ruling overturns a May 2005 dismissal by New Jersey Superior Court Judge Carol Higbee, who is overseeing about 15,000 lawsuits filed by plaintiffs claiming Vioxx caused their heart attacks. It is unclear how many people would qualify for medical monitoring at this point in time, but there are likely hundreds of thousands of people who may qualify to participate if a class-action lawsuit is certified. "It's too early to say how many people may become involved, but it's a very exciting decision," said Esther Berezofsky, who is representing the plaintiffs. "And it's important because the court, essentially, said that you can have medical monitoring in pharmaceutical cases in New Jersey, not just environmental or toxic exposure cases." An attorney for Merck downplayed the importance of the ruling. "The appellate court did not endorse the plaintiffs' position nor did it reject Merck's position on the law," said Ted Mayer of Hughes, Hubbard & Reed, "It simply stated that the lower court order dismissing the complaint was premature. ... The ruling therefore instructs the lower court to reconsider the validity of plaintiffs' claims after more fact gathering is completed."

Posted by Patricia Bowling at 02:06 PM | Permalink

FDA Warns Doctor Over Stem Cell Implants

A Las Vegas doctor has been implanting stem cells harvested from from placentas into patients with multiple sclerosis, muscular dystrophy, and other diseases in violation of federal, according to federal health officials. Dr. Alfred Sapse has not obtained or even sought federal approval to carry out his procedures, which also are done by at least one doctor under Sapse's direction. Oversight of such implants is important to avoid infecting patients with viruses or bacteria.

FDA Warns Doctor Over Stem Cell Implants

Sapse has not properly obtained, stored, tested or processed the placentas or adequately screened the suitability of his donors and patients. At least 16 patients have been implanted with the stem cells. Sapse claims on his website to have carried out 42 stem cell implants on patients with MS, Alzheimer's, muscular dystrophy, cerebral palsy, and other disorders. He is a Romanian-trained ophthalmologist. Since the late 1980s, doctors have been using the blood from the placenta and the umbilical cord as a source of adult stem cells. Theses cells are able to develop into the major components of blood and are useful in fighting disease.

Posted by Patricia Bowling at 01:48 PM | Permalink

FDA Finds Problems in Studies by Pa. Firm

Federal regulators said that they have found problems with a Philadelphia firm's review of new medicines and said that the drug companies who hired it will have to re-evaluate test results. MDS Pharma Services had been working with the Food and Drug Administration to look at concerns about testing at its two Canadian facilities from 2000 to 2004. The FDA approved drugs that were approved based on the MDS Pharma test results now will have to be reviewed, though FDA officials say that there has been no evidence of a safety risk.

FDA faults drug studies by Pa. firm

FDA officials are not yet sure how many drugs are affected. More than 1,100 letters are being sent out to identify the drugs looked at by MDS Pharma. "We expect there not to be major problems, but we are casting nets to cover all bases on this issue," said Joseph Famulare, the deputy director of the FDA's drug compliance office. MDS Pharma has not yet responded to a request for comment. MDS Pharma typically is hired by drug makers in order to determine the level of a drug in a patient's bloodstream.

Posted by Patricia Bowling at 01:38 PM | Permalink

Do Statins Increase Risk of Parkinson's?

Those taking cholesterol-lowering statin drugs may be at a significantly higher risk of developing Parkinson's disease. Statins are intended to reduce levels of low-density lipoproteins (LDLs), which are responsible for carrying cholesterol from the liver to cells in the body. A U.S. study has found that patients with low LDL levels are three times more likely to have Parkinson's disease and researchers plan to begin large scale trials to decide if statins are the cause of the increased risk.

Do Statins Raise the Risk of Parkinson's?

Experts, however, are reassuring patients that statins are safe and very beneficial to the health of those who are taking them. Dr. Xuemei Huang, of the University of North Carolina, compared the occurrence of Parkinson's in 236 patients with different LDL levels. Those with the lowest LDL levels were three and a hald times more likely to have the disease than those with higher levels. Huang said that her results made her "definitely concerned and this is why she's conducting a prospective study of 16,000 people."

Posted by Patricia Bowling at 04:30 PM | Permalink

Warfarin May be Cause of Increased Numbers of Strokes

A recent study leads to the conclusion that the sudden increase in the number of hemorrhagic strokes in the United States during the 1990s may be linked the the increase in use of the anti-clotting drug warfarin. The study says that the rate of strokes increased 500% during the same period of time in which the distribution of warfarin increased dramatically. The researchers say that their findings should make doctors more cautious about prescribing medication to elderly patients at high risk of hemorrhagic stroke.

Anti-clotting drug may have fuelled hemorrhagic stroke boom in the US

"Patients suffering from an irregular heart rhythm, also known as atrial fibrillation, commonly receive warfarin to prevent the formation of blood clots. This is because clots can sometimes form when blood is not pumped normally out of the heart and lingers there too long," said Matthew Flaherty of the University of Cincinnati in Ohio. Flaherty also emphasized the importance of warfarin in saving lives. "Warfarin is good medicine and the message is not that it shouldn't be used."

Posted by Patricia Bowling at 11:33 AM | Permalink

SCAI Issues Clinical Alert on Drug-Eluting Stents

The Society for Cardiovascular Angiography and Interventions (SCAI) has released a clinical alert alerting physicians on steps to reduce the risk of serious complication associated with the use of drug-eluting stents. The panel supports the continued use of drug-eluting stents, but says that more research is needed to determine whether there is an increased likelihood of heart attack and death in heart attack patients who have the stents.

SCAI Issues Clinical Alert on Drug-Eluting Stents and Late Thrombosis

"Practicing physicians and their patients are naturally concerned by the recent finding of a very small, but important risk of very late stent thrombosis. Since SCAI's membership includes the vast majority of practicing interventional cardiologists, we felt it was critical to give some practical advice and guidance in an attempt to ensure optimal outcomes for our patients with coronary artery disease. Coronary artery disease is still the number one cause of death in the Western world, and anything we can do to maximize therapy while minimizing risk is welcome." said John McB. Hodgson, M.D., FSCAI, the lead author of the clinical alert.

Posted by Patricia Bowling at 01:56 PM | Permalink

Study Raises Questions about Weight-Loss Drugs

Canadian researchers say that the long-term risks and benefits of popular weight loss drugs are not known. Dr. Raj Padwal and Dr. Sumit Majumdar, both from the University of Alberta, say that more long-term studies are needed in order to decide whether losing weight with the help of drugs sibutramine (Meridia,) orlistat (Xenical,) and rimonabant (Acomplia) really reduce the risks of heart attack, stroke, and diabetes that comes from being overweight.

Study Raises Questions About Weight-Loss Drugs

Padwal and Majumdar reviewed all the published studies on the weight loss drugs to draw their conclusions. "These three medications will likely lower weight, modestly, but we need better studies," Padwal said. "The studies that are out there don't provide information on cardiovascular disease and cardiovascular deaths. The other problem is that they are not long-term and have high dropout rates. We really need to know what the net benefits of these medications are, and truly know whether we should be using them or not." Padwal also noted that "If you are going to prescribe a weight-loss drug, the ultimate goal is not a cosmetic one. The ultimate goal is to get that person to be healthier and lower their risk of having cardiovascular problems."

Posted by Patricia Bowling at 11:01 AM | Permalink

Cold Medicines Dangerous for Infants

Government research shows that over-the-counter cough and cold medications can be harmful to very young children. Dr. Adam Cohen, study author and officer at the Epidemic Intelligence Service at the U.S. Centers for Disease Control and Prevention, said that :"Cough and cold medicines can be harmful, and even fatal, and should be used with caution in children under 2 years of age. They are drugs, so they have risks as well as benefits."

Cold Medicines Dangerous for Infants

In 2005, three infants under the age of 6 months died as a result of having being given such medications. More than 1,500 children under the age of 2 were treated in emergency rooms for complications from taking such drugs. The U.S. Food and Drug Administration has only approved the use of over-the-counter cold and cough medications in children over the age of 2. In children younger than 2, medications are believed not to have an effect stronger then the placebo effect. "Cold and cough medications, especially medications containing pseudoephedrine [a nasal decongestant], have never been shown to have any beneficial effect on children less than 2 years of age, yet they clearly can have significant harmful effects," said Dr. Michael Marcus, from the Maimonides Infants & Children's Hospital in New York City.

Posted by Patricia Bowling at 01:07 PM | Permalink

FDA to Pull Unapproved Drugs from Market

A U.S. Food and Drug Administration official told representatives from 65 companies who sell unapproved drugs that the FDA plans to increase efforts to remove unapproved drugs from the market. Deborah Autor, the director of the FDA's Office of Compliance, said that the FDA "does intend to accelerate removal of unapproved drugs this year."

FDA to Sweep Unapproved Drugs Off the Market

A recent USA Today cover story revealed that nearly 2% of drugs of prescription drugs have never been studied by the FDA. The article inspired Senator Chuck Grassley, of Iowa, to write to the FDA's Commissioner Andrew von Eschenbach to ask about why unapproved drugs end up on the market. The FDA does not yet plan to ban all unapproved drugs; according to Autor, the FDA is taking a "concerted and concentrated approach" and is "constantly evaluating potential targets."

Posted by Patricia Bowling at 11:35 PM | Permalink

U.S. Approves Dog Weight Loss Drug

The United States Food and Drug Administration has approved the first weight loss drug for obese dogs. Pfizer manufactures the drug, known as Slentrol. Slentrol works by decreasing appetite and fat absorption. Roughly 5% of dogs in the United States are obese and another 20-30% are overweight.

US approves weight-loss drug for obese dogs

"This is a welcome addition to animal therapies because dog obesity appears to be increasing," says Stephen Sundlof, the head of the FDA's Center for Veterinary Medicine. Side effects of Slentrol include vomiting, loose stools, diarrhea, and lethargy. Overweight dogs face increased risk of developing diabetes, heart problems, and joint problems.

Posted by Patricia Bowling at 06:30 PM | Permalink

Parkinson's Drugs May Damage Heart Valves

Two recent studies indicate that two drugs used in the treatment of Parkinson's disease may damage heart valves in a way similar to the banned diet drug fen-phen. About one-fourth of patients taking pergolide or cabergoline, sold under the names Permax and Dostinex, had moderate to severe heart valve problems. Another study found users of the drug to be five to seven times more likely to have leaky heart valves than those taking other Parkinson's treatments.

Heart valve risk with some Parkinson’s drugs may be greater than believed, 2 studies show

Dr. Bryan Roth, a pharmacology professor at the University of North Carolina at Chapel Hill, said the data were alarming. “This is an extraordinarily high risk. It’s a bad side effect. As far as I know, there are no medications that can reverse it,” and valve replacement surgery is the only solution, he said. Permax is used to treat Parkinson's and restless legs syndrome. Cabergoline is sold as Dostinex and Cabaser, primarily in Europe. About half a million people had taken Permax during its first 14 years on the market before Eli Lilly and Co. realized heart valve dangers and added a warning on the package. However, the company said that the risk was much lower than the new data indicate.

Posted by Patricia Bowling at 05:58 PM | Permalink

FDA: Food From Clones is Safe

The U.S. Food and Drug Administration has formally stated that the meat and milk from cloned cattle, pigs, and goats is safe. However, the report did not satisfy critics who say that cloning animals is unethical. 64% of Americans said in a recent poll that they would be somewhat "uncomfortable with animal cloning."

FDA says food from clones is safe

Carol Tucker from the Consumer Federation of America's Food Policy Institute said that "Neither the agency nor animal scientists are qualified to tell us whether and when it is ethically acceptable for humans to alter the essential nature of animals." The FDA based its decision that cloned animals were as safe to eat as uncloned animals in comparing properties of the two kinds of meat. "We looked at essential elements like vitamins, fatty acids — a whole array of different components — to try to determine if there was any distinguishable difference between foods from clones and their offspring compared to foods from conventionally raised animals," said Stephen F. Sundlof, director of the Center for Veterinary Medicine. "There was no difference."

Posted by Patricia Bowling at 08:16 PM | Permalink

FDA Does Not Use Advisory Committees Effectively

According to a recent Public Citizen study, the U.S. Food and Drug Administration is not using its advisory committees effectively when considering the approval of new drugs. The study was published in the current edition of the Lancet medical journal. Public Citizen says that the FDA frequently allows drug companies to make oral presentations about their drugs without an opposing FDA presentation. 18% of the time, the FDA fails to present its own interpretation of drug company data.

FDA Does Not Use Advisory Committees Effectively in Approving New Drugs, Public Citizen Writes in Lancet Medical Journal

The FDA has 18 drug advisory committees who give the FDA independent advice. However, there has been very little study about how the committees actually function. Dr. Peter Lurie, the deputy director of Public Citizen's Health Research Group, said that the study indicated that while “advisory committees are a vital element of the nation’s drug safety net, but by failing to use these committees adequately, this resource is being squandered.”

Posted by Patricia Bowling at 07:57 PM | Permalink

Rituxan Warning Issued

Biogen and Genentech have sent a letter to healthcare providers, warning them that two lupus patients taking the drug Rituxan died of the rare brain disorder PML. PML is usually seen only in people with severely compromised immune systems. Rituxan is an immunomodulator drug that acts by modeling the antibody rituximab. This is the second time that Rituxan has been linked to PML, a condition typically only seen in patients with advanced AIDS. The FDA notes that PML has also been seen in lupus patients taking immunomodulator drugs other than Rituxan.

Biogen, Genentech issue warning for Rituxan

Rituxan is used to treat non-Hodgkin's lymphoma and rheumatoid arthritis, but also is used in off-label treatment of lupus. Off-label prescribing is often done in cases where patients do not respond well to standard therapies. Dr. Steven Galson, the director of the FDA's Center for Drug Evaluation and Research, said that "Rituxan is used in both approved and off-label settings, and therefore it is very important for prescribers as well as patients to be aware of these new reports of the risk of PML."

Posted by Patricia Bowling at 01:54 PM | Permalink

January 31, 2007

Antidepressants Linked to Fracture Risk

January 30, 2007

FDA Considers New Standards for Birth Control Drugs

January 29, 2007

Beta-Agonists May Cause Thousands of Asthma Deaths Each Year

January 26, 2007

No Evidence to Support Off-Label Users of Atypical Antipsychotics

January 25, 2007

Court Will Review Vioxx Health-Test Suit

January 24, 2007

FDA Warns Doctor Over Stem Cell Implants

January 23, 2007

FDA Finds Problems in Studies by Pa. Firm

January 22, 2007

Do Statins Increase Risk of Parkinson's?

January 19, 2007

Warfarin May be Cause of Increased Numbers of Strokes

January 18, 2007

SCAI Issues Clinical Alert on Drug-Eluting Stents

January 17, 2007

Study Raises Questions about Weight-Loss Drugs

January 16, 2007

Cold Medicines Dangerous for Infants

January 15, 2007

FDA to Pull Unapproved Drugs from Market

January 12, 2007

U.S. Approves Dog Weight Loss Drug

January 11, 2007

Parkinson's Drugs May Damage Heart Valves

January 10, 2007

FDA: Food From Clones is Safe

January 09, 2007

FDA Does Not Use Advisory Committees Effectively

January 08, 2007

Rituxan Warning Issued