Avandia | Type 2 Diabetes Drug
Manufactured by GlaxoSmithKline, Avandia
(generic name rosiglitazone) is a commonly prescribed drug used to treat Type 2 Diabetes. On
May 21, 2007, the Food
and Drug Administration (FDA) issued a safety alert for Avandia. In this alert, the FDA stated that "Recently, the manufacturer of Avandia
provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled
clinical trials in which Avandia was compared to either placebo or other anti-diabetic
therapies in patients with type
2 diabetes. The pooled analysis suggested that
patients receiving short-term (most studies were 6-months duration) treatment
with Avandia may have a 30-40 percent greater risk of heart attack and other
heart-related adverse events than patients treated with placebo or other anti-diabetic
therapy. This data, if confirmed, would be of significant concern since patients
with diabetes are already at an increased risk of heart disease.
"The American Diabetes Association recently revised its guidelines to endorse less expensive, older drugs such as the generic metformin, as first-line treatments. The ADA and the European Association for the Study of Diabetes also said that a joint medical panel "unanimously advised against using" Avandia.
Recently, the consumer advocacy group Public Citizen asked the FDA to ban Avandia. According to Public Citizen, its research has found 14 cases of liver failure in Avandia patients, 12 of which resulted in death.
The FDA told the Wall Street Journal that it will review the petition carefully. The FDA is now holding advisory panel meetings on the dangers of Avandia. This panel's recommendations could result in several possible courses of action, including a black box warning on the Avandia label (the FDA's strongest warning), limitations on who can be prescribed Avandia, a total recall of Avandia or no action whatsoever.
In its June 14th issue, the New
England Journal of Medicine published an article on the effect of Avandia (rosiglitazone)
on the risk of myocardial infarction and death from cardiovascular causes. The article reported problems regarding Avandia's side effects, based on an independent meta-analysis. This study was conducted by Kathy Wolski, M.P.H. and Steven Nissen, M.D, a renowned cardiologist from the Cleveland Clinic. Dr. Nissen had previously published a study on problems with the arthritis
drug Vioxx, which was then recalled in 2004.
The study evaluated 42 trials that compared patients taking Avandia with those who weren't. The total study involved 28,000 patients, of which 15,560 were taking Avandia. Of the patients who took Avandia, 86 suffered heart attacks, as compared to 72 patients not taking the drug. Additionally, another 39 patients died from cardiovascular causes compared to 22 patients not taking Avandia.
The authors of the study indicated that these new findings are "worrisome" because of the high incidence of cardiovascular events in patients with diabetes. According to the authors, "Because
exposure of such patients to rosiglitazone is widespread, the public health impact
of an increase in cardiovascular risk could be substantial if our data are borne
out by further analysis and the results of larger controlled trials."
Worldwide, more than 6 million people have used Avandia to help control blood sugar in people with Type 2 Diabetes. Approximately 1 million Americans are prescribed Avandia. However, since the onslaught of information about Avandia's risks, many doctors have quit prescribing Avandia in favor of alternative drugs considered to be safer. In fact, following the release of the article in the New England Journal of Medicine, the number of new prescriptions for Avandia dropped by 40%.
Based on the significant research available, Avandia has been linked to an increased risk of serious injuries and possible death due to heart attacks, strokes and heart failure. If you or someone you care about has taken Avandia and suffered serious side effects as a result, please fill out our Case Review Contact Form to the right on this page to find out what your case is worth.
GlaxoSmithKline is circling the wagons around Avandia as leading medical groups
began telling doctors not to use the diabetes med. As we reported a couple of
days ago, the American Diabetes Association revised its guidelines to privilege
older, cheaper drugs, such as the generic metformin, as first-line treatments.
But the ADA and the European Association for the Study of Diabetes also said
that a joint medical panel "unanimously advised against using" Avandia.
And now, the consumer
advocacy group Public Citizen is calling on the FDA to ban the drug, which has been linked with a variety of safety problems, including an increase in the risk of heart attack and stroke. Public Citizen said it has also found 14 cases of liver failure in Avandia patients, 12 of which resulted in death.
FDA told the Wall Street Journal that it will review the petition carefully.
As you know, FDA officials have been split over whether to withdraw Avandia or
leave it on the market with stronger warnings on its label. GSK, for its part,
says it hasn't looked at the Public Citizen petition. "We do not believe there is a connection between liver toxicity and this medicine," the
company said, adding that Avandia is safe and effective when used appropriately.
Avandia has lost ground from its once top-selling status since May 2007, when major safety questions first arose. But Public Citizen says that 10,000 scrips are still being filled each day. The drug and a sister combo formula pulled in $313 million in third quarter sales alone.
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