Pfizer to Test Lipitor as Over-the-Counter Drug
Pfizer announced that it would run tests to see if patients can responsibly self-dose themselves with Lipitor and its generic versions so that the company can sell the statin over-the-counter.
Recent changes in clinical guidelines for treating heart disease and high cholesterol have led to changes in how doctors prescribe drugs like statins to prevent heart disease in patients with high cholesterol. This, along with personal injury concerns about Lipitor’s link to Type 2 diabetes, could make the studies more difficult for Pfizer.
Some doctors and pharmacists believe that an over-the-counter statin could be useful for many patients who suffer from high cholesterol. Others argue that a strong drug with serious side effects needs the guidance of a physician.
Despite criticism, Pfizer starts a clinical trial with 1,200 patients to see if the group could get blood tests for their cholesterol and make the right decisions with their medication – in this case, Lipitor – in order to regulate their cholesterol levels.
The clinical trial will recruit patients through 35 US pharmacies, and will be completed at the end of the year. If successful, Lipitor and its generic versions could become the first over-the-counter statin medication.
“The OTC status is another access point,” says Mark Gelbert, a senior vice president of global research and development with Pfizer’s consumer health-care unit. “It’s our responsibility to demonstrate patients can safely and effectively use these products.”
Neil Stone, a co-author of the new cholesterol guidelines, is a critic of Pfizer’s proposal for over-the-counter Lipitor. “The new guidelines insist on a patient-clinician discussion before a statin prescription is written,” says Dr. Stone, a cardiologist and professor at Northwestern University’s Feinberg School of Medicine. He says that, along with ensuring appropriate medication doses, doctors will also discuss healthy lifestyle changes, which patients may not do for themselves.
Pfizer has not mentioned yet what percentage of the 1,200 patients will be women, who often run a higher risk of developing Type 2 diabetes from taking Lipitor.
The Strom Law Firm Is Now Investigating Lipitor Cases
Although many doctors believe that the benefits of statins such as Lipitor outweigh the risks, patients who are otherwise healthy disagree. Type 2 diabetes carries the risk of a wide variety of different side effects, including increased risk of heart and blood vessel disease, nerve damage or neuropathy, kidney damage, osteoporosis, Alzheimer’s disease, skin and mouth conditions, and diabetic macular edema, which can lead to blindness.
In 2012, the FDA forced label changes for Lipitor and other statins include a warning about the potential increased risk of diabetes. The warnings added by Pfizer to the prescription bottles for Lipitor® failed to completely and adequately address the increase in risk of diabetes and the importance of monitoring blood glucose levels. As a result, thousands of women may have developed diabetes after taking Lipitor®.
The attorneys at the Strom Law Firm are currently investigating claims that taking Lipitor is related to development of Type 2 diabetes. There may be a limited time to file a claim, so contact us today for a free consultation. 803.252.4800