FDA actions

FDA actions

The FDA has issued a new warning and is requiring label changes to all statins regarding the risk of elevated blood sugar and reversible cognitive changes. The agency is making these changes after a comprehensive review of multiple studies that show increases in blood sugar associated with the drugs. A separate labeling change warns that cognitive effects have been reported with statin use, including transient memory loss and confusion — symptoms that are reversible with stopping the medication. There is no evidence that statins are associated with long-term cognitive changes or dementia. Statins affected by these warnings include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. In a separate warning, lovastatin is now contraindicated with strong CYP3A4 inhibitors, such as itraconazole and erythromycin. This is a similar warning to that issued for simvastatin in 2011.

In one of the strangest stories of the year, the FDA is warning oncologists that a counterfeit version of bevacizumab (Avastin) may have been purchased and used by some medical practices in the United States. The counterfeit version does not contain any active drug and may have resulted in patients not receiving needed therapy. Counterfeit bevacizumab was purchased from a foreign supplier known as Quality Specialty Products or Montana Health Care Solutions. The FDA is recommending that physicians stop using bevacizumab purchased from the suppliers and call the FDA immediately.