Zocor Side Effects Means No OTC, but What About Lipitor?
Recent news reports show that manufacturer Pfizer is looking into selling its cholesterol-lowering drug Lipitor as an over-the-counter medication. The company has assembled teams to evaluate the feasibility of the switch, including whether or not the FDA would go for it.
Considering the FDA’s past decisions on similar matters, however, Pfizer is likely fighting an uphill battle, as it was only a few years ago that Zocor manufacturer Merck & Co. tried the same thing with Mevacor (lovastatin), and failed. Yet despite reports of serious Zocor side effects like Zocor muscle injury, the U.K. already approved Zocor for over-the-counter (OTC) use in 2004.
FDA turns down initial U.S. applications for OTC status
In July 2000, the FDA rejected applications from Merck & Co. and Bristol-Myers Squibb for switching Mevacor (lovastatin) and Prevachol (prevastatin) to OTC status. The proposed dosage of both was a low 10 mg.
The Nonprescription Drugs Advisory Committee agreed that both statins at that dosage were clinically safe and effective for use in those people considered at moderate risk for a major cardiovascular event. The FDA didn’t necessarily disagree, but their concern was that consumers wouldn’t use the drugs appropriately without the help of a prescribing doctor.
U.K. approves Zocor for OTC regardless of Zocor side effects
In 2004, the U.K. became the first country in the world to sell a cholesterol-lowering drug without a prescription—in this case, Zocor, or “Zocor Heart-Pro” as it’s branded for OTC use. A 10 mg pill meant to be taken daily, Zocor Heart-Pro is marketed to those people at moderate risk of heart disease, and was approved by the British government based on recommendations by the Committee on Safety of Medicines.
Though many cardiologists were in favor of OTC statins, critics claimed the move was simply a way for the manufacturer to rejuvenate sales, since Zocor had come off its patent in the U.K. An editorial in the scientific journal Lancet was especially concerned with the risk of Zocor side effects. It warned the U.K. public would be “the guinea pigs in this large-scale OTC experiment,” and raised concerns about Zocor muscle injury, Zocor rhabdomyolysis, and interactions with prescribed drugs.
The Royal College of General Practitioners echoed this concern, stating that without access to a patient’s medical record, pharmacists wouldn’t be able to protect them from interactions and adverse effects.
Would a Zocor OTC lead to more Zocor lawsuits?
The FDA says that in order to sell Lipitor OTC, Pfizer will have to show that patients can safely diagnose themselves and use the drug properly. Whether or not they’ll be able to do that remains to be seen, but earlier FDA rejections have cited data from studies of consumer behavior that showed only half of consumer purchases of a cholesterol-lowering drug were appropriate. Some buyers were too young for the drug, others didn’t know their cholesterol levels, and still others had contraindications for the drug because of their medical conditions. In addition, women of childbearing age bought the drug, and statins have shown in studies to increase the risk of birth defects.
Meanwhile, Zocor side effects like Zocor muscle injury, rhabdomyolysis, renal failure, heart problems, and even diabetes continue to come to light, with many victims filing a Zocor lawsuit in an attempt to win compensation for medical expenses.