Propecia Debate Continues

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propecia_cancer_debate_continuesAn emerging study reveals that finasteride, the active ingredient in male pattern baldness medication, Propecia, is again the focus of some controversy.

In 2003, a study involving 18,000 men found that Propecia reduced prostate cancer risks by 30 percent, according to The New York Times. In a higher dose.

Approved in 1997 to treat male pattern baldness, Propecia (finasteride 1 mg) is part of a class of drugs known as 5-alpha reductase inhibitors (5-ARIs). Propecia’s active ingredient can interfere with male hormones, including testosterone derivatives. In higher doses, the drug is sold under the brand name Proscar and is approved to treat men with benign prostatic hyperplasia (enlarged prostate) or urinary problems.

Finasteride has not been approved by the U.S. Food and Drug Administration (FDA) for the prevention of prostate cancer over a worrisome finding. While the drug did reduce overall risks for prostate cancer, more men who used the drug developed fast-growing tumors.

A just-released study in The New England Journal of Medicine revealed that 14-17 years after the men first enrolled in the study, there was no change in survival in men who used finasteride when compared to those who took a placebo. The finding, based on a review of Social Security death records, suggests finasteride was not causing the aggressive tumors and was likelier reducing the size of the prostate, improving detection of aggressive tumors, the Times explained. The study authors note that use of finasteride will not prolong life or protect from aggressive prostate cancer, according to the Times.

Meanwhile, lawsuits are mounting against Merck & Company, maker and marketer of Propecia over allegations that include long-term, sometimes permanent, sexual side effects. Over 400 lawsuits are pending in state and federal courts over Propecia over allegations of side effects, such as loss of libido, erectile dysfunction, and infertility. More than 140 lawsuits have also been consolidated in multidistrict litigation in the U.S. District Court for the Eastern District of New York. In state courts in New Jersey, over 50 cases have been consolidated, as well.

Plaintiffs allege Merck knew about the risks of ongoing side effects, pointing out that Propecia labels in other countries were changed as long ago as 2008 and mentioned those risks.

Recent research revealed that Propecia sexual side effects seen in some men may be permanent, not the first time similar links have been made with the popular hair loss drug. The Institute for Safe Medication Practices (ISMP) found that in the FDA’s Adverse Event Reporting System (FAERS), reports of permanent Propecia sexual side effect risks. “Nearly 20 years after approval, evidence is now emerging that the sexual side effects of finasteride may sometimes be irreversible and were most notable in the younger men taking finasteride for male pattern baldness,” the ISMP study indicated.

Prior studies have also reported potential links with Propecia to sexual side effects, including erectile dysfunction, diminished sex drive, and orgasm problems; other research suggested that Propecia use is linked to depression. The potential complications were seen to possibly persist even years after treatment was stopped.