The Food and Drug Administration said it will rewrite the labels for Propecia and Proscar brand finasteride to warn of reports of libido, ejaculation and orgasm disorders, male infertility, and/or poor semen quality even after the patient stops using the drugs. Is this what Propecia plaintiffs’ lawyers have been saying for a long time?
The new warnings on the Propecia label will include libido, ejaculation, and orgasm disorders that continued after discontinuation of the drug. The new warnings to the Proscar label will include decreased libido that continued after patients stop taking the drug. Both labels disclose that patients have claimed male infertility and/or poor semen quality that normalized or improved after men stopped using these drugs. (This might be right.)
The FDA is not willing to say that causation has been definitively established between finasteride and these sexual problems, but at least admitted that case reports “suggest a broader range of adverse effects than previously reported in patients taking these drugs.”
This new information adds fuel to the Propecia lawsuit fire. These cases may soon be consolidated into a class action lawsuit for discovery purposes. A hearing is set for April.
You can find more information on potential Propecia lawsuits here.