Avandia Heart Problems Confirmed By Yet Another Study

New research adds further weight to concerns about potential Avandia heart problems, which have already led to the diabetes drug being heavily restricted in the United States and recalled in many countries around the world. 

A study published on March 17 in the British Medical Journal compared GlaxoSmithKline’s Avandia with Actos, a competing drug by Takeda Pharmaceuticals. Researchers from England found that Avandia users had a higher risk of heart problems and death, supporting the findings of prior studies.

Researchers looked at the results of 16 observational studies that included more than 800,000 Avandia or Actos users. They found that Avandia patients had a 23% higher risk of congestive heart failure, 16% higher risk of heart attack and 14% higher risk of death. The researchers determined that for every 100,000 patients taking Avandia instead of Actos there could be approximately 431 more deaths, 649 more cases of heart failure and 170 more heart attacks.

Avandia (rosiglitazone) was first approved in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics in the U.S., but sales began to plummet in mid-2007, following the concerns about potential Avandia heart risks.

A “black box” warning was added to Avandia in the United States in November 2007, but many critics continued to argue that the warning was not strong enough and called for an Avandia recall to be issued in the United States.

In September 2010, the FDA decided not to recall Avandia, allowing the medication to remain on the market with severe restrictions on who can use the product. The agency determined that only patients who have failed to control their diabetes through every other available medication should be given access to the medication, and ordered the drug’s maker, GlaxoSmithKline, to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted.

GlaxoSmithKline has faced thousands of Avandia lawsuits that were filed by people who allege that the drug maker failued to adequately warn about the risk of heart problems from Avandia. A number of Avandia settlements have reportedly been reached by GlaxoSmithKline in an effort to resolve the litigation.