GlaxoSmithKline Plc was warned by government regulators in 2001 not to downplay heart problems associated with its Avandia diabetes drug that a study published this week linked to an increased risk of heart attacks.
The US Food and Drug Administration warned Glaxo in a July 2001 letter that its marketers should stop denying or minimizing that patients taking the drug along with insulin had an increased risk of “heart failure or other cardiovascular adverse events,” according to a copy of the letter on the FDA’s website. A Cleveland Clinic study published 21 May by the New England Journal of Medicine found Avandia users were 43% more likely to have a heart attack than those on other diabetes drugs.
“Any competent plaintiffs lawyer will try to use this to show that Glaxo had a pattern of failing to disclose or downplaying the risks of heart problems tied to Avandia,” Alex MacDonald, a Boston-based lawyer who specializes in suing pharmaceutical companies, said on 24 May in an interview.
Glaxo’s shares have fallen 8% in London since the Avandia study was announced. Glaxo officials said about 7 million people worldwide have taken Avandia and about 1 million US residents are currently using the drug. Doctors and patients said they are weighing whether to continue prescribing or using the medicine, which is the world’s top-selling diabetes treatment. Glaxo’s sales of the drug were $3 billion last year.
Glaxo spokeswoman Mary Anne Rhyne said in an interview that the company responded to the FDA’s letter by warning doctors and by making sure marketers disclosed the risks in future presentations.“We made sure it didn’t happen again,” Rhyne said.
The FDA sent five warning letters to Glaxo in a two-year period starting in 1999 over the company’s advertising and marketing of the diabetes drug. Regulators criticized Glaxo in the July 2001 letter for continuing to “engage in false or misleading promotion of Avandia.”
Earlier, in February 2001, the company had agreed to change Avandia’s warning label to show that studies found an increased risk of heart problems for patients taking the drug in combination with insulin.
FDA officials noted in the July 2001 letter that company officials who knew of the risks “denied their existence” at a meeting of the American Association of Clinical Endocrinologists. The company also “minimized the risks in certain labeling pieces,” regulators said in the letter.
Because of the “seriousness” of the company’s violations, FDA officials required Glaxo to make the risks clear in letters to doctors and other health-care providers, according to the July 2001 letter.