Propecia to Get New Side Effects Warning Labels
The U.S. Food and Drug Administration (FDA) has announced that Propecia, a drug used for treating hair loss, will get updated warning labels advising users of the potential risk for sexual side effects.
Propecia (finasteride) was first approved by the FDA in 1997 to treat male pattern baldness. Finasteride is a synthetic 5-alpha-reductase inhibitor, an inhibitor of the enzyme that converts testosterone to dihydrotestosterone (DHT)In recent years, Propecia has become the target of several lawsuits filed by men who claimed the drug caused serious complications, including sexual dysfunction. Last year, Propecia’s warning labels were updated after it was determined that a number of men continued to experience erectile dysfunction after they stopped taking the drug. The FDA based its decision to update the drug’s warning labels once again following a review of approximately 421 reports of sexual dysfunction that were received through the agency’s Adverse Event Reporting System.
Of the 421 reports, 59 of the men involved claimed to have experienced a range of problems, including erectile dysfunction, decreased libido, difficulty ejaculating and orgasm disorders that last for at least three months after they discontinued using Propecia. The FDA noted that overall, the rate of sexual side effects was relatively low, with one Propecia study indicating that approximately 36 (3.8 percent) of 945 men had reported one or more adverse sexual experiences taking the pill, as compared to 20 (2.1 percent) of 934 men who took a placebo. The agency issued a statement acknowledging that while there was no definitive link between Propecia and sexual dysfunction, the adverse event report cases did suggest that the incidence of sexual side effects may be higher for patients who use the drug.
In addition to the potential for sexual side effects, Propecia has also been linked to an increased risk of developing prostate cancer. In June 2011, the FDA issued an updated safety communication advising patients and healthcare providers of the potential for an increased risk of prostate cancer associated with finasteride. Specifically, the FDA cited the results of a research study which indicated that the risk of developing high-grade prostate cancer risk was higher among men aged 55 and older who were taking Propecia.
Men who have experienced sexual dysfunction or been diagnosed with prostate cancer after taking Propecia may be entitled to compensation for their medical bills, lost wages and pain and suffering. If you or someone you know has been adversely affected after using Propecia, it’s important that you contact an experienced California personal injury lawyer to discuss your case. A qualified Propecia side effects attorney can ensure that your rights are protected.
Nadrich & Cohen, LLP is currently investigating Propecia side effects claims in all 50 states. For more information on filing a Propecia lawsuit, call 1-800-718-4658 to begin your free initial case evaluation. There is never a fee unless damages are recovered on your behalf.