Propecia sales down; lawsuits continue; media cover side effects

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Faced with the 2013 onset of generic competition against its male pattern hair loss drug, Propecia (finasteride), Merck has experienced diminishing dollars while it has tried to make sense of the hundreds of Propecia lawsuits filed by men (and some spouses) who have suffered enduring erectile problems and related side effects since using the drug.

Before the loss of market exclusivity became an issue, Merck saw its Propecia sales stagnate at $447 million in 2010 and 2011 and then decline to $424 million in 2012. As the Propecia patent has approached its October 2013 sunset, one generic competitor already has been allowed into the market in January and another will get the green light in July. Propecia sales in the first quarter of 2013 were down 37 percent to $68 million compared to the same period in 2012.

The plaintiffs have shed no tears over Mercks Propecia sales losses. Realizing that their health suffered from an increased risk of severe Propecia side effects, about which the manufacturer should have known and warned about, these victims have hired counsel and have pursued recoverable damages.

Actually, there are two Merck drugs involved in this sort of litigation.

Proscar is the other finasteride-containing Merck drug involved in the litigation. The U.S. Food and Drug Administration approved it in 1992 for the treatment of an enlarged prostate and to reduce the risk of urinary retention or the need for surgery related to that condition.

The FDA gave Propecia the nod in 1997 for the treatment of male pattern hair loss.

Temporary erectile side effects were included in the products labels at the time of approval, according to the FDA, but the persistent complications, lasting even after the patient stopped taking the drug, were not incorporated into the warnings. Who would gamble on permanent losses of this magnitude given a choice? But there was no proper warning, so there was no legitimate choice, claimants can assert.

The FDA wrote, In controlled clinical trials, these side effects resolved in patients who stopped finasteride, as well as in most patients who continued therapy. In 2011, both Proscar and Propecias labels were revised to include erectile dysfunction that continued after drug discontinuation.

Propecias prescribing information since April 2012 has enumerated adverse reproductive system effects that have continued after discontinuation of treatment, including male infertility.

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Propecia sales down; lawsuits continue; media cover side effects