Pfizer is abandoning its plans to pursue over-the-counter (OTC) sales of its widely prescribed cholesterol-lowering statin Lipitor because a late-stage trial failed to show that patients would comply with the directions and have their cholesterol levels checked before using the drug.
Many drug companies have sought – and received – approval to market over-the-counter versions of their prescription drugs for convenience and wider appeal. Heartburn drugs such as histamine H2 antagonist Zantac and proton-pump inhibitor Prilosec were first prescription-only drugs and are now readily available OTC. Anti-allergy drugs Claritin and Zyrtec are also OTC versions of prescription meds. Even painkillers such as Motrin, Advil and Aleve provide the convenience of lower-dose OTC versions of prescription drugs ibuprofen and naproxen.
Pfizer sought the same opportunity for Lipitor in an effort to stave off predicted lagging sales from generic competition. The company set up dozens of clinical trials involving tens of thousands of patients over multiple years to demonstrate that consumers could follow the directions deemed necessary by the Food and Drug Administration (FDA) and not take the drugs until after taking a blood test to determine that a statin was necessary.
Unfortunately, consumers don’t want to be bothered with details like blood work. Thus, Pfizer has given up on going OTC with its statin.
The FDA would probably have also raised concerns about Lipitor side effects, much like it is now with many of the OTC versions of prescription drugs. The agency recently added warnings to NSAID painkillers, including Advil, Aleve and Motrin, that the drugs can increase the risk of heart attacks.
Lipitor can increase blood sugar levels, and thus put users at risk for developing type 2 diabetes. Diabetes is a growing problem not just in the United States, but also worldwide. The chronic condition leads to heart disease, kidney disease, cancer, dementia and other health problems, and contributes to a growing public health burden. Authorities agree that Lipitor should remain a prescription drug so its use and side effects can be more closely monitored.