Product Liability

Is it safe to sell cholesterol-lowering drugs without a prescription?

Cholesterol-lowering statins were the most prescribed medication in 2010, and drug maker Pfizer hopes to make its drug Lipitor even more widely available by making it available over-the-counter, without a prescription.

Statin medications are a class of drugs used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, which plays a central role in the production of cholesterol in the liver. High cholesterol levels have been linked to cardiovascular disease, the leading cause of death in the United States, according to the National Institutes of Health.

Side effects associated with statin medications are relatively rare, but can be deadly. The drugs can cause severe muscle and liver damage. One known side effect from all statins is a muscular disease known as  Myopathy, which causes pain, tenderness or weakness in the muscles. Myopathy can lead to rhabdomyolysis, a more serious condition that can lead to kidney failure, which can be fatal.

Despite these risks, Pfizer is pursuing over-the-counter options for the medication. But it may be an uphill battle for Pfizer. The Food and Drug Administration (FDA) has rejected previous bids to make statins available without a prescription.

Lipitor is one of the most widely used statins, and in 2003 was considered the best-selling pharmaceutical in history with sales in the billions.

Source: Private MD Labs