It is reported that the pharmaceutical company Pfizer, which manufactures the cholesterol-lowering drug atorvastatin (Lipitor), will attempt to gain FDA approval to sell the drug over the counter. The patent on Lipitor expires in November, which means that generic versions of the drug will drive the cost way down. Selling Lipitor over the counter would help make up for the lost profits for Pfizer. It’s not the first time Big Pharma has tried to gain this status for a statin drug—in 2008 an FDA advisory panel rejected applications from Merck for over-the-counter lovastatin, another statin drug. This application was rejected for a number of good reasons.
Drugs that have already taken the leap from prescription to over-the-counter status are those intended for temporary or intermittent treatment of symptomatic conditions like allergy, pain or gastric reflux (I won’t get into the inappropriate long-term use of over-the-counter proton pump inhibitors here—I’ve blogged on that before). Long-term treatment of asymptomatic conditions like high cholesterol requires physician monitoring of dosage, response and side effects. Liver damage and muscle pain are the most common side effects of statins. While muscle pain is obvious, liver damage can occur with no side effects, highlighting the importance of physician monitoring while on these medications.
Further, there is valid concern that consumers will not be able to appropriately select statin drugs and use them correctly. Consumers with little risk for a cardiovascular event may take over-the-counter statins with false hopes that the drug is benefitting them. Proper dosage is another factor—consumers needing a higher dose may mistakenly take a low dose, while those needing a low dose may overmedicate themselves.
For all these reasons, the FDA rejected the previous attempt at approval of over-the-counter statins. Let’s hope the FDA will take the same position with Pfizer’s attempts to gain over-the-counter status this time around. Statin drugs are already over-prescribed.