FDA Announces Drug Withdrawals (Zelnorm and Pergolide)
Posted Oct 28 2008 9:57pm
Yesterday, the FDA announced the voluntary withdrawal of the pergolide products due to “the risk of serious damage to patients’ heart valves.” The products, which are used to treat Parkinson’s Disease, are Permax, marketed by Valeant Pharmaceuticals and two generic versions manufactured by Teva and Par.
Eli Lilly’s Permax (pergolide) was originally approved in 1998. The link to adverse events in patient’s heart valves was first identified in 2002 and subsequent efforts to get physicians to utilize the product appropriately were unsuccessful (including stronger label language, black box warnings and “dear doctor” letters).
Next up for the FDA’s voluntary withdrawal hit list, Novartis’ Zelnorm. This one got yanked because of a minor, and NOT statistically significant, sub-population in an 18,000 person study. 13 people out of 11,614 (or 0.11%) had an increase adverse cardiovascular events. Every one of the patients had pre-existing cardiovascular disease and risk factors (i.e., the doctor never should have put them on the drug in the first place).
Zelnorm is personal for me. I have a very close friend who has lived for years with debilitating IBS. Zelnorm was a miracle drug for her and allowed her to live her life…a normal life. What does she do now?
The FDA needs to find a way to balance adverse events with patient benefits. It is a tragedy when a patient dies or is injured by an adverse event. It is also terribly cruel to deny a patient a medication that has changed her life because 0.11% of people in a study had an adverse event (patients who shouldn’t have been on the drug in the first place if the doctor was doing their job).