Propecia Side Effects: European Warning Labels Differed from American Labels

Newark, NJFor plaintiffs who have filed a Propecia lawsuit, news that the US Food and Drug Administration (FDA) had updated the warnings about Propecia side effects may not have come as a surprise. What might be surprising, however, is that Propecia side effects in men now reportedly include an increased risk of developing an aggressive form of prostate cancer. Men who filed lawsuits against the maker of Propecia allege they suffer from Propecia sexual dysfunction, and they say Merck, maker of Propecia, knew about these side effects long before warning patients about them.

According to lawsuits, the evidence that Merck knew about the risk of sexual dysfunction lies in the warning that was included on Propecia labels in Europe. BNET (01/13/11) reports that in Sweden, Propecia is required to warn on the label that the sexual side effects could be irreversible, meaning that once Propecia is discontinued, patients may still experience sexual dysfunction.

The same BNET article notes that the Propecia warning label in the US warned only that two percent of men might experience sexual side effects while taking Propecia, but those side effects would reverse once the medication was discontinued. For men deciding whether or not to take the medication to prevent hair loss, there is a big difference between reversible and irreversible side effects.

Making the situation worse is the disparity between the warning label and a recent study published in the Journal of Sexual Medicine (03/11). The warning label warns only that two percent of men might experience sexual side effects, but the study suggests up to 15 percent of men could experience sexual side effects.

Those sexual side effects reportedly include decreased libido, erectile dysfunction and ejaculatory disorders.

Propecia, known generically as finasteride, is used to stop men's hair from thinning and is also used at a higher dose to treat enlarged prostate.

The FDA has recently added to the list of concerns about Propecia, issuing a warning that the drug could increase a patient's chances of being diagnosed with high-grade prostate cancer. High-grade prostate cancer is an aggressive cancer that can spread quickly. The FDA's warnings were based on trials of Proscar and Avodart, which contain higher doses of finasteride than Propecia does. The warning was added to Propecia as well because it still contains the same active ingredient.