The US Food and Drug Administration (FDA) asked the drug company Merck to extend warnings about possible sexual side effects, including male infertility, of the two drugs Propecia and Proscar.
Both of the mediations contain a main active ingredient called finasteride which reduces male hormone activity which is also associated with side effects.
The labels on both drugs will now include a description of reported cases of male infertility that improved after patients stopped taking the drug.
The new label for the baldness medicine Propecia will include libido and other sexual disorders that continued after discontinuation of the drug.
Proscar, which treats symptoms of enlarged prostate will now have a label that adds “decreased libido that continued after discontinuation of the drug.”
Labels on the two drugs already warn of thse side effects but health officials want physicians and patients to know the problems may continue to occur even after patients stop taking the medications.
“Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have not been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs,” the FDA added.
“Therefore, prescribers and patients need to be aware of them, as part of a discussion of risk and benefits of finasteride when determining the best treatment options.”
The warning may have been influenced by reported cases of infertility treatments of men who were taking the drugs.
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