U.S. drug regulators have issued a long awaited decision on the diabetes drug Avandia, placing severe restrictions on the drug’s use. The decision comes at the same time that European regulators recommended that an Avandia recall be issued in Europe.
The FDA announced on Thursday that it is significantly restricting the use of Avandia in the United States. From now on, Avandia will only be available to patients with Type 2 diabetes who cannot control the disease with any other medications. As a result, GlaxoSmithKline will have to develop a risk evaluation and mitigation strategy (REMS) that will keep the drug out of the hands of anyone who doesn’t need it.
The FDA also announced that it was halting a clinical trial, known as TIDE, which would have compared the health risks of Avandia to those of a competing drug, Actos, by Takeda Pharmaceuticals. In July, FDA halted enrollment in the clinical trials after critics have called the trials unethical because they could be knowingly exposing human test subjects to potentially fatal drug side effects.
The European Medicines Agency has gone a step further and issued a recall for Avandia, banning it from use throughout the European Union.
The decisions come after three years of debate which pitted FDA staff and independent experts against one another on the issue of whether or not Avandia side effects caused heart attacks. It is likely to disappoint some critics of Avandia, including some FDA drug safety reviewers and consumer watchdog groups, who wanted a U.S. Avandia recall as well.
“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted following the allegations of an increased risk of heart attacks and congestive heart failure .
GlaxoSmithKline’s once-blockbuster diabetes drug has come under harsh criticism in recent years by a number of experts, including some FDA drug safety reviewers, who have estimated that Avandia heart problems may be responsible for more than 100,000 heart attacks and deaths since it was approved. Critics have argued that there is no reason to put patients at risk with the drug when there are alternative treatments that do not appear to carry the same heart attack risk as Avandia.
Many analysts say that Avandia was already effectively a dead product after an FDA advisory committee agreed that it increased the risk of heart attacks and death in July. Although the committee did not call for Avandia to be recalled, the FDA could have still decided to do so to protect consumers.
GlaxoSmithKline faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients that of Avandia heart attack risks. Earlier this summer the company announced it had reached Avandia settlements in about 10,000 of those suits.