Avandia Recall Should be Issued in U.K. Says British Medical Journal

U.K. drug regulators and a respected medical journal are calling for an Avandia recall to be issued in Great Britain, saying that the drug is unsafe and should have never been approved for sale. 

In August, the United Kingdom’s Committee on Human Medicines advised that nation’s Medicines and Healthcare products Regulatory Agency (MHRA) to pull Avandia from the market because Avandia health risks outweighed any potential benefits. And last week the British Medical Journal (BMJ) published an article saying that its own investigations have led it to conclude that there needs to be an Avandia recall. Another editorial in the same issue said there needs to also be some soul-searching on behalf of the European drug regulatory community as to how Avandia got on the market in the first place.

While the MHRA has yet to issue a recall of Avandia in the U.K., it did send out a letter to doctors suggesting that they seek alternatives to the medication for the treatment of type 2 diabetes. However, MHRA officials say they intend to push for a full recall of the drug before the European Medicines Agency (EMA), which is reviewing whether to keep Avandia on the market for all of Europe.

Similar deliberations are occurring in the United States within the FDA, which is also nearing a final decision on whether to issue an Avandia drug recall.

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 side effects 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.

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 .

“No new patients should be started on rosiglitazone, and patients already taking it should be reviewed and alternative treatments considered,” concluded John Yudkin, emeritus professor of medicine at University College London, in BMJ’s Avandia investigation. “Those at higher risk of heart disease should be advised to stop taking the drug.”

The BMJ article lauded the openness of the U.S. drug review system and the FDA’s handling of hearings on the side effects of Avandia, which were open to the public. But it criticized the EMA for holding its deliberations in private and giving no reason as to why it first rejected Avandia in 1999 and then approved the drug in 2000 with no apparent new evidence. It also pointed out that the public was not notified that the Committee on Human Medicines had actually recommended a recall for Avandia.

The medical journal also criticized GlaxoSmithKline’s studies as being bad science and self-serving, saying that errors in the studies appeared to systematically favor the drug. GlaxoSmithKline refutes the BMJ editorial, saying that its studies were conducted with sound science and that it believes Avandia to be safe and effective.

Many analysts say that Avandia is 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 may still decide to do so despite to protect consumers. In July, FDA also  halted enrollment in new clinical trials that would compare the health risks of Avandia with those of Actos, a competing drug by Takeda Pharmaceuticals. Critics have called the trials unethical because they could be knowingly exposing human test subjects to potentially fatal drug side effects.

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. Ear;ier this summer the company announced it had reached Avandia settlements in about 10,000 of those suits.