Plans For Over-The-Counter Lipitor Abandoned By Pfizer Due to Self-Treatment Risks

The drug manufacturer Pfizer has reportedly dropped plans to further capitalize on their blockbuster Lipitor brand, abandoning attempts to introduce an over-the-counter (OTC) version of the cholesterol drug after trials suggested that users will have trouble regulating their own cholesterol levels without monitoring by a healthcare professional. 

Pfizer began clinical trials for Lipitor OTC in 2013, involving more than 1,311 subjects. The goal was to test whether the use of a 10 mg over-the-counter version of Lipitor could safely help consumers lower low-density lipoprotein cholesterol levels, or “bad” cholesterol, without obtaining a prescription from their doctor.

What the company found was that in the 26 week time frame, those who took the pill often failed to check their cholesterol levels appropriately, and if high cholesterol levels were detected, the test subjects failed to seek out appropriate medical attention. Essentially, the study determined that self-monitoring cholesterol levels may lead to potential health risks that would be addressed by keeping the drug as a prescription medication.

Lipitor is one of the most well-known brand-name prescription drugs in the world, and a major revenue generator for Pfizer. However, sales have dropped in recent years following the introduction of Lipitor generic equivalents in 2011, with Pfizer seeing their $10 billion per year drug generate just over $2 billion last year. In 2012, there were 9.75 million prescriptions for brand-name Lipitor, and 45.15 million prescriptions for generic competitors.

According to a report by Bloomberg News, the findings the recent clinical trials have led the company to abandon plans for Lipitor over-the-counter, which it hoped would boost revenue.

Lipitor belongs to a class of cholesterol drugs known as statins, which also include popular medications like Crestor and Zocor. Statins are used to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease.

Although the medications are widely used and generally regarded as safe, a number of studies have linked statins to an increased risk of potentially serious injuries, including muscle damage, kidney problems, and diabetes.

In February 2012, the FDA required the makers of Lipitor, Crestor and other statins to add new warnings about the potential impact of the medication on blood glucose levels. However, many critics have suggested that the warnings are not strong enough for certain medications, indicating that users and the medical community should be provided with more accurate information about the diabetes risks with Lipitor, Crestor and other statins.

Pfizer currently faces hundreds of Lipitor diabetes lawsuits filed by women throughout the United States, who allege that the drug maker knew or should have known about risks associated with their medication for years, but withheld diabetes warnings to avoid a negative impact on sales and growth of the blockbuster medication.