According to sources in the Wall Street Journal this week, Pfizer said they would apply to sell Lipitor over the counter. This is a bad, bad idea. Lipitor is in the class of medications commonly called statins. Although it’s an excellent drug, it can have serious side effects, including liver and muscle damage. Presumably an OTC dose would be low, and less likely to cause side effects, but it’s still likely patients would inadvertently take it in addition to statins prescribed by their doctor, or along with red yeast rice, a naturally occurring statin.
Even if there was zero risk of side effects, there is a high risk that patients would not use the medication properly. Lipid (cholesterol, triglycerides (fats), HDL (good cholesterol), LDL (bad cholesterol), etc.) management can be quite complex. One should know medical problems that might exacerbate the problem, such as diabetes and thyroid problems. There are many medications to choose besides statins, and different ones work better for some people than others. Then you have to know how aggressively to treat, which depends on the risk of cardiovascular disease, among other things.
Over-the-counter Lipitor would certainly be cheaper than the current prices, but it would likely be more than the generic price. Even if priced below generics, it could cost consumers more because their insurance would likely not cover it if it was available over-the-counter. This is what happened with the antihistamines Allegra and Zyrtec, though generic Claritin (loratadine) is quite cheap now.
So given all the down sides, why would Pfizer try to get OTC Lipitor approved? I wonder if it could have anything to do with their loss of patent protection when it goes generic 11/30/11?! Fortunately it’s unlikely the FDA will fall for this.