Wyeth in Trouble with FDA
Following a loss in a suit against it for the relationship between breast cancer and its menopause hormone replacement therapy (HRT) drugs Premarin and Prempro, pharmaceutical manufacturer Wyeth has been struggling with the FDA over several drugs, including two products designed to fill the market niche earlier occupied by the HRT products. The most recent hang-up is the FDA’s demand that Wyeth answer more questions and hand over more data before the agency rules on the new experimental osteoporosis medicine bazedoxifene. This demand for additional information is a good thing, since hearings on Premarin and Prempro have revealed that the company had reason to expect the various problems that arose from users of the drugs. Suspicions about the drugs became clear as soon as sufficiently large studies were conducted. Hopefully, the new data demanded by the FDA will prevent a similar situation from occurring with the new drug. Wyeth claims it has already submitted data supporting approval of the drug, a study covering nearly 1,000 women, that had not yet been considered by the agency.
Osteoporosis is the loss of calcium-based minerals in the bones, making them more susceptible to breakage, and particularly affects women immediately following menopause. The disease only hit public awareness after Wyeth promoted its cure as a side effect of HRT.
Wyeth has a separate application in for approval of bazedoxifine for the treatment of osteoporosis in progress, although a decision on that application is not expected until May.
Other recent setbacks for Wyeth include the August 10 rejection of its experimental schizophrenia drug, bifeprunox, because the drug was not as effective as other treatment options available. The main advantage claimed by Wyeth for this drug is that it did not result in weight gain for its users. The FDA also declined to approve Pristiq, a nonhormonal menopause treatment, because of possible side effects on the heart and liver, until Wyeth conducts additional trials to ensure the drug’s safety. (Note that Wyeth was hoping to replace HRT with two separate products, doubling its sales for the same treatment.)
Although these struggles may signal that the FDA is not so much in the power of the pharmaceutical companies as some fear, these demands for more information and study are as much a show to prove the agency’s power as real attempts to protect the public health. In December alone, the FDA approved or gave tentative approval to over 30 new drugs, many of which will be manufactured and marketed under numerous trade names by several companies. With this flood of new drugs, how can we hope to know which will prove dangerous in the near future?
If you or someone you love has been injured as a result of a pharmaceutical, or you fear that you may be suffering unanticipated side effects of your medication, contact PersonalInjury.com today to get in touch with a pharmaceutical injury lawyer who can get compensation for you and protect others by getting those dangerous drugs off the market.