FDA mandated label change on the hair loss drug Propecia
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- Created on Tuesday, 18 October 2011 14:24
Recently, the FDA announced a label change for the Merck manufactured hair loss drug, Propecia. The new label will include a warning to reflect the increased risk of developing prostate cancer for those taking the medication. Propecia underwent a series of trials and was found to increase the risk of developing high-grade prostate cancer.
This comes on the heels of other significant trouble facing Propecia. Many patient have/are experiencing major sexual side effects from taking the drug, included but not limited to, Erectile Dysfunction, Abnormal Sexual Function, Impotence, Ejaculation disorder, Decrease in ejaculatory volume, Lower sex drive (decreased libido), Breast or Prostate Cancer, and Male breast growth (gynecomastia). There are several cases where these side effects continue even after discontinuing use of Propecia.
Propecia does mention side effects in their Propecia packaging; however, Merck allegedly suggested that Propecia had minimal side effects while knowing of the long-term and sometimes permanent sexual side effects of taking the hair loss pill. And they may have been underrepresenting the increased risk of permanent erectile dysfunction (ED)
Oftentimes drug companies try to escape liability under a legal theory called the learned intermediary doctrine which, in this case, attempts to shift responsibility in that the doctor should inform their patients of warnings or side effects if the manufacturer has adequately informed the doctor. Of course, with so many drugs coming out each year, with their own set of risks and warnings, it seems more realistic for the onus to be on the manufacturer to properly inform patients about their drugs and the side effects thereof.
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