Before a prescription drug can be marketed in the U.S. it is put through a series of trials and must gain the approval of the Food and Drug Administration (FDA). Once the drug has been placed on the market, the FDA continues to monitor it through post-marketing reports sent in by the manufacturer and through the MedWatch program - an FDA program that allows consumers and health care professionals to report serious side effects, quality control issues, and medical errors associated with drugs and products regulated by the FDA. Sometimes, an unanticipated side effect manifests itself once the drug has made it onto the U.S. market. If the side effect is serious enough, the FDA may issue a warning to the public and/or request that changes be made to the drug's label. If the side effect is extremely serious and the FDA decides that the risks of the drug outweigh its benefits, then the FDA may recall the drug.
Spotlight - Defective Drugs
In the same class as two other COX-2 inhibitors withdrawn from the market, Celebrex® is a medication used for the treatment of arthritis. As a result of the Vioxx® and Bextra® recalls, it has recently come under scrutiny. The label of Celebrex® has undergone several revisions, warning physicians and patients of the risk of cardiovascular and gastrointestinal problems associated with the drug.
Vioxx® was recalled in September of 2004 due to an elevated danger of cardiovascular problems connected with use of the arthritis drug. A long-term study revealed that the danger posed by Vioxx® increases the longer patients use the medication for treatment.
Another popular arthritis drug touted as a pain reliever with a reduced risk of causing gastrointestinal damage, Bextra® was recently removed from the market. The increased risk of cardiovascular problems, in addition to dangerous skin reactions warranted the Bextra® recall.
Zyprexa® is a medication used to treat the symptoms of schizophrenia and bi-polar disorder. However, recent reports have linked Zyprexa® to blood sugar disorders and other adverse side effects that could be dangerous to your health.
Baycol® was voluntarily withdrawn from the market by Bayer Pharmaceutical Division, following evidence of harmful side effects associated with the medication. Baycol® is a cholesterol drug that was recalled due to incidences of rhabdomyolysis, some of which were fatal.
Contact the Law Offices of Justin London if you have been injured or the victim of a defective drug.