Product News and Recalls

Lipitor studies withdrawn because of flaws

Researchers have withdrawn three substudies of the anti-cholesterol drug Lipitor, after Pfizer – the company that both manufactures the drug and sponsored the clinical trial – discovered an error.

A story in Forbes says blood samples from the study had been matched to the wrong participants. According to story, the study results had been published in the New England Journal of medicine in 2005. They had a major impact on clinical practice and prescription patterns for statins – the class of medication that includes Lipitor.

Since then, other studies have raised health concerns about the drug.

The U.S. Food and Drug Administration has added warnings to the labels of Pfizer’s Lipitor and other types of statins, advising that they may increase the risk of Type II diabetes. The new labels also warn that the drugs may raise blood sugar levels, and could cause memory loss.

And while the clinical trials used to get regulatory approval for statins put the rate of people reporting side effects at 5 to 10 percent, a more recent study published in Annals of Internal Medicine put that number at closer to 17 percent.

Forbes says the withdrawn substudies helped bolster medical providers’ heavy use of statins, making Lipitor a highly profitable drug for Pfizer in the process.

A story on the withdrawal in Retraction Watch says scores of papers were based on the database compiled in the flawed study. Now the question remains as to what the long-term impact on those papers will be.

Patients should consult their doctors before making any changes in their medication. A consultation with a Lipitor lawyer is also important if there are significant injuries.

See the Forbes story here:

See the Retraction Watch story here: