Just after the FDA issued a Safety Communication concerning Statin drugs and drug-to-drug interaction with HIV and Hepatitis C drugs, there is more, as the most recent concern is diabetes and the FDA updated the “warnings and precautions” on this group of popular medications to advise of their concern.
Statins include top selling brand names such as Lipitor, Crestor and Zocor – as well as a dozen or so other branded and generic versions under various names. The drugs are prescribed to more than 20 million Americans a year, at a cost of more than $14 billion in 2011, according to the research firm IMS Health.
The FDA warned that patients taking cholesterol-fighting Statins face a small increase in the risk of higher blood-sugar levels and of being diagnosed with diabetes.
The FDA’s action follows analyses of large numbers of Statin studies in recent years. In one, published in the Lancet in 2010, researchers looked at 13 studies including 91,140 patients. The researchers concluded that Statin therapy “is associated with a slightly increased risk of development of [Type 2] diabetes, but the risk is low both in absolute terms and when compared to the reduction in coronary events.”
“The diabetes issue is a really big deal. We’re overlooking the Statin use,” stated Eric J. Topol, a prominent cardiologist and chief academic officer of Scripps Health in LaJolla, Calif.
In addition, the FDA said labels for Statin drugs now will contain information about patients experiencing memory loss and confusion, though this side effect was classified as an “adverse reaction” rather than one of the warnings and precautions, a more serious category.
Amy Egan, the FDA’s deputy director for safety of metabolic and endocrinological products, stated, “these cognitive changes can be quite dramatic” and “sustained” but that they disappear when Statin therapy is stopped. Egan also said the agency cannot identify a specific drug or age group of people who might be prone to such cases and that patients should notify their doctors if these symptoms occur.
Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, stated, “There is no question that Statins slightly increase the risk of a diabetes diagnosis and of slightly higher blood sugar, but I think this has no impact on the risk-benefit assessment. I know I can lower the [relative] risk of death, stroke and heart attack by about thirty percent in patients at high risk of such cardiovascular events.”
According to Topol research suggests for every 200 people who take a Statin, one will develop diabetes and by comparison, one to two out of 100 patients at risk for a heart attack will avoid one. He stated, “That’s a very narrow margin of benefit.”
Robert Califf, vice chancellor for clinical research and a cardiologist at Duke University Medical Center stated that the diabetes issue is ‘real’ but ‘not a huge effect.’
Continuing, he stated, “Informing people is a good thing, but for the vast majority of people who really need to be on a Statin, this shouldn’t change what they do.”
The warning isn’t expected to prompt doctors to stop prescribing Statins for patients with multiple risk factors for heart attack. Cardiologists stated that for many patients,