The U.S. Food & Drug Administration (FDA) announced yesterday that new warnings will be added to labels of <"http://www.yourlawyer.com/topics/overview/5-alpha-Reductase-Inhibitor-Proscar-Propecia-Avodart-Jalyn-Prostate-Cancer-Lawsuit">Proscar, Avodart, Jalyn and Propecia regarding a possible association with high-grade prostate cancer. Proscar, Avodart and Jalyn are all used to treat enlarged prostate, while Propecia is used to treat male pattern hair loss. Avodart and Proscar are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.
Proscar and Propecia (both known generically as finasteride) are made by Merck, while Avodart (dutasteride) and Jalyn (dutasteride and tamsulosin) are manufactured by GlaxoSmithKline. All belong to a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.
The FDA decided to modify the labels for the drugs after two large studies showed that while 5-ARIs reduced the overall risk of prostate cancer, they increased the risk that a user would develop a more serious type of tumor known as high-grade prostate cancer. This type of tumor grows and spreads faster compared to low-grade prostate cancer. According to the FDA, high-grade prostate cancer is a serious disease, but accounts for a small portion of all diagnosed prostate cancers.
In a Drug Safety Communication issued yesterday, the FDA said it would modify the “Warnings and Precautions” sections of the labels of all FDA-approved 5-ARIs to include new information that they may increase the risk of high-grade prostate cancer. The product labeling will also state that 5-ARIs are not approved for the prevention of prostate cancer. Even though it is not used to treat enlarged prostate, the Propecia label will be changed because it contains the same active ingredient in Proscar, although the dosage is lower.
The FDA said it continues to believe the benefits of the drugs in treating enlarged prostate outweigh their risks.
Last year, Glaxo sought approval from the FDA to market Avodart for prostate cancer prevention, but the agency denied the request, citing the risk of high-grade prostate cancer. The clinical trial Glaxo presented to the FDA to garner the expanded approval for Avodart, called the REDUCE trial, was one of the two on which the agency based the new prostate cancer warning. Glaxo is now abandoning its effort to gain expanded approval for the drug in light of the FDA’s decision.