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5 December 2013 11:26 am ,
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An animal rights group known as the Nonhuman Rights Project filed lawsuits in three New York courts this week in an...
Researchers have been hot on the trail of the elusive Denisovans, a type of ancient human known only by their DNA and...
Thousands of scientists in the Russian Academy of Sciences (RAS) are about to lose their jobs as a result of the...
Dyslexia, a learning disability that hinders reading, hasn't been associated with deficits in vision, hearing, or...
Exotic, elusive, and dangerous, snakes have fascinated humankind for millennia. They can be hard to find, yet their...
Researchers have sequenced and analyzed the first two snake genomes, which represent two evolutionary extremes. The...
Snake venoms are remarkably complex mixtures that can stun or kill prey within minutes. But more and more researchers...
At age 30, Dutch biologist Freek Vonk has built up a respectable career as a snake scientist. But in his home country,...
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FDA, Europe Curb Risky Diabetes Drug
23 September 2010 3:22 pm
The United States and Europe are both greatly restricting use of the diabetes drug Avandia, culminating several years of concern that the drug increases the risk of heart problems. The European Medicines Agency (EMA) is taking Avandia off the market, while the U.S. Food and Drug Administration (FDA) is placing the drug in a special high-risk category that is likely to drastically cut its use.
Both agencies had access to the same Avandia data, which was compelling but also incomplete. The conclusion that Avandia causes heart attacks and other cardiac issues came from combining data from many different clinical trials, a method that's less powerful statistically than individual trials designed to answer such questions. "My job would be infinitely easier if we had consensus and scientific clarity on this issue," said Margaret Hamburg, FDA's commissioner, in a press conference this morning. But she concluded the evidence justified significant restrictions.
Most frustrating to regulators, a large clinical trial specifically requested by European regulators to address risks, called RECORD, has come under fire for failing to properly assess cardiac events. FDA officials said today that their next step will be to have the company that makes Avandia, GlaxoSmithKline, set up an independent review panel to reassess all potential cardiac issues that surfaced in RECORD patients.
In the meantime, Avandia will become a lot harder to get. FDA has placed it under a special program it runs called Risk Evaluation and Mitigation Strategies. REMS is designed to ensure that the benefits of potentially risky drugs continue to outweigh the hazards for every patient taking them. The program currently includes drugs such as the acne medication Accutane, which causes birth defects. FDA has also halted a Glaxo trial that aimed to compare Avandia with another drug used by diabetics, Actos, which is considered safer. FDA had suspended the trial in the summer.
In Avandia's case, patients who wish to continue using it will have to sign a document acknowledging that they understand the drug's risks. New patients will be eligible to take it only if doctors certify that other treatments haven't brought the patients' blood sugar under control and that they cannot take Actos for medical reasons. "We believe this action will considerably limit the number of people who are on [Avandia]," said Janet Woodcock, director of the Center for Drug Evaluation and Research in Silver Spring, Maryland.
For European regulators, limiting Avandia's use was deemed insufficient, and within a few months Avandia will no longer be available in most European countries. "The accumulated data support an increased cardiovascular risk of rosiglizatone," the generic name for Avandia, said EMA in a statement. "The benefits of rosiglitazone no longer outweigh its risks." But Woodcock noted there was still "considerable uncertainty about the magnitude and the existence of this cardiovascular risk." She is hopeful that reassessing RECORD will help.