Propecia (generic: finasteride), a 5-alpha reductase inhibitor (5-ARI) used to combat male pattern baldness and treat enlarged prostates, was approved in 1997 and is manufactured by Merck and Co.
FDA Safety Alert for Propecia
In June 2011, the Food and Drug Administration (FDA) issued a safety alert warning of a 63 percent increased risk of a serious form of prostate cancer for Propecia users. Use of Propecia and other 5-ARI class drugs may decrease the overall chance for men of developing lower risk forms of prostate cancer; however, use of the same drugs has been shown to increase risk of high-grade prostate cancer.
The FDA issued the safety alert following its review of two large studies: the Prostate Cancer Prevention Trial (PCPT) and Reduction by Dutasteride of Prostate Cancer Events (REDUCE). The results from PCPT indicate that men who take Propecia face a 63 percent higher risk of high-grade prostate cancer than men taking placebos.
Propecia’s safety label has since been updated to reflect the high-grade prostate cancer risk, but this change comes too late for the men who were prescribed the drug, including an astounding 5 million patients between 2002 and 2009.
High-grade cancer is extremely aggressive, growing and spreading more quickly than low-grade. In short, high-grade cancer is substantially more dangerous. Propecia manufacturer Merck should have ensured that every man who was prescribed Propecia in the 15 years since its approval was warned of this increased and potentially fatal prostate cancer risk.
Long-term Sexual Dysfunction
The risk of sexual issues, including erectile dysfunction and reduced libido, has long been associated with Propecia but was always touted as temporary. Men were told that the issues would go away as soon as Propecia use was discontinued. Two studies published in The Journal of Sexual Medicine have found that the sexual issues linked to Propecia may continue after use of the drug has stopped. The study published in the March 2011 issue revealed that 5 to 23 percent of men experienced sexual side effects. Even worse, according to the study’s author, the side effects did not subside for half of those men.
Suspicious Behavior by Merck & Co.
As of February 2012, Merck & Co. removed the website dedicated to Propecia. Propecia.com now displays a message indicating that the site is unavailable, raising concerns that Merck may be about to unveil new warnings regarding Propecia-related risks. The page provides links for prescribing information, patient product information, enrollment in the Propecia Persistence Program, a Propecia refund and the FDA’s MedWatch site to report negative side effects. If Merck reveals new warnings for Propecia, it would fuel current lawsuits and encourage more men who may have been harmed by the hair loss drug to file claims.
Patients who were prescribed Propecia should have been warned of the persistent sexual side effects and increased risk of high-grade prostate cancer, but they were not. Manufacturer Merck and Co. had a legal and ethical responsibility to research all possible risks associated with Propecia and then warn consumers of any adverse side effects. The drug company did not do so, and innocent people have suffered as a result. Victims of Propecia injury deserve compensation for physical, financial and emotional burdens caused by Merck’s irresponsibility
If you or a loved one has been diagnosed with prostate cancer or has suffered from sexual issues after taking Propecia, contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation. Our experienced team of drug injury lawyers will work closely with you and see to it that you are compensated for your injuries.