Lipitor OTC Version Pushed by Pfizer, Amid Safety Concerns

Pfizer is trying to develop an over-the-counter (OTC) version of the popular cholesterol drug Lipitor, as concerns continue among consumers and the medical community about the potential issues associated with widespread use of statin medications.

Lipitor is the most popular brand-name prescription drug in the world, and a major revenue generator for Pfizer. However, sales have dropped in recent years from more than $10 billion per year to just over $2 billion in 2013, amid competition from generic equivalents. 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 the Wall Street Journal, Pfizer is starting a 1,200 patient clinical study involving a low-dose Lipitor pill, which the drug maker hopes will become the first statin-based cholesterol drug to become available over-the-counter, without a prescription. The trial is expected to be completed by the end of the year.

The move comes amid recent concerns about the increasing use of Lipitor, Crestor and other statin-based drugs, which have been described as the “statinization” of America, where drug makers are pushing for indefinite prescriptions of the drugs for the prevention of heart problems. There have also been increasing concerns in recent years about the potential risk of diabetes from Lipitor and other statin medications.

Statin Concerns

Late last year the American Heart Association and the American College of Cardiology called for new heart guidelines which some say would put millions of additional Americans on Lipitor, Crestor and other cholesterol drugs indefinitely. The recommendations suggest that statins should be the only drugs doctors prescribe to lower cholesterol levels and call for doctors to toss out cholesterol goal numbers, potentially keeping patients on the drugs permanently.

While those guidelines appear to bolster Pfizer’s efforts for an over-the-counter Lipitor to take advantage of all the new would-be statin users, the guidelines also call for physician participation in all statin use, which would work against a non-prescribed, over-the-counter drug. The primary reason for the requirement that a doctor be involved in, and monitor, the use of statins are safety issues.

Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. However, a number of studies have linked the drugs 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 from Lipitor, Crestor and other statins.

Pfizer faces hundreds of Lipitor diabetes lawsuits filed by women throughout the United States, who allege that use of the medication as a preventative measure to prevent heart failure has caused them to develop diabetes, which carries a number of health risks, including an increased risk of heart disease. Plaintiffs claim that the drug maker knew or should have known about Lipitor diabetes problems for years, but withheld information to avoid a negative impact on sales and growth of the blockbuster medication.

AstraZeneca also faces a number of Crestor lawsuits filed on behalf of former users of the cholesterol drug who were diagnosed with diabetes. Most of those cases are currently pending in California state court.