As previously reported, Propecia must now warn its users that high-grade prostate cancer may result from the use of the hair loss prevention drug.
The FDA has notified healthcare professionals that the Warnings and Precautions section of Propecia to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
The new safety information is based on FDA’s review of two large, randomized controlled trials. Finasteride (Proscar), dutasteride (Avodart), and dutasteride in combination with tamsulosin are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Finasteride (Propecia) is approved to treat male pattern hair loss.
In a possible sign that they recognize the problems their drug has caused, Propecia has all but dismantled their website: http://www.propecia.com/sitedown.html. According to the official Propecia website: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."
If you have taken Propecia and have experienced unusual symptoms, or worse, developed prostate cancer, and have questions, please feel free to email dtobin@cssfirm.com or call toll free at (800) 641-0098.
