US agency criticises diabetes drug Avandia

Patients who take Avandia, a popular diabetes drug made by GlaxoSmithKline, are far more likely to suffer and die from heart problems than those who take Actos, a similar pill made by Takeda, the US Food and Drug Administation (FDA) has said.

Patients who take Avandia, a popular diabetes drug made by GlaxoSmithKline, are far more likely to suffer and die from heart problems than those who take Actos, a similar pill made by Takeda, the US Food and Drug Administation (FDA) has said.

Avandia is particularly dangerous to patients who also take insulin. By contrast, Actos can be taken safely with insulin, according to the review.

The findings are likely to end Avandia’s status as one of the most popular drugs in the US for treating diabetics who are not dependent on insulin.

Reports and charges that GlaxoSmithKline sought to intimidate a doctor who gave a public warning about Avandia’s risks in 1999 could lead to a cascade of lawsuits against GlaxoSmithKline. FDA reviewers, who were sharply critical of the quality of studies GlaxoSmithKline has undertaken to test the safety of Avandia, dismissed the present and future results of an ongoing 4,000-patient trial as unreliable and invalid.

The report by medical and safety reviewers within the FDA also suggests that top FDA officials have been far too slow to acknowledge Avandia’s risks. GlaxoSmithKline suggested a year ago that the agency add a note to the drug’s label about Avandia’s growing heart risks, the report states.

FDA safety reviewer David Graham has also concluded that a safety alert released by top FDA officials on May 21 falsely reassured patients that a large Avandia study had shown the drug was safe. That study, Graham says provided no such reassurance.

The conclusions come in a 436-page compilation of reviews released in advance of an advisory panel hearing to be held on Monday to discuss Avandia’s effects on the heart. FDA intends to ask the committee of independent experts whether Avandia should continue to be sold.

Story continues below this ad

In 2000, the FDA had ordered that a drug called Rezulin be removed from the market because the drug caused more liver problems than Actos or Avandia, both of which were approved for sale in 1999. Avandia’s heart risks are likely to injure far more patients than Rezulin’s rare but serious effects on the liver. Most diabetics die of heart disease.