Contact A Lawyer
Have A Potential Case Reviewed By An Attorney
A new study appears to confirm the hair restoration drug Propecia increases the risk of suicide and other psychological adverse events warning that the risk may be particularly higher among younger men taking the prescription medication.
Researchers from Harvard Medical School report finding a disproportionate rate of incidence of suicidality, depression and anxiety linked to Propecia use for reversing hair loss among patients under the age of 45. The findings were published in JAMA Dermatology online on November 11.
Propecia (finasteride) is a prescription medication marketed by Merck to help men restore natural hair loss that occurs with male pattern baldness. The active pharmaceutical ingredient was originally developed by Merck as a niche treatment for enlarged prostate, and marketed as Proscar in 1992. It was later approved to treat male pattern baldness, when it was given the brand name Propecia and aggressively marketed in direct-to-consumer advertisements encouraging men to contact their doctors about the prescription.
In July 2015, a study published in the medical journal Pharmacotherapy found a strong link between the use of Propecia and suicide risks. That study looked at nearly 5,000 adverse event reports submitted to the FDA and found a strong link between sexual dysfunction side effects associated with the drug and reports of attempted suicide.
In this latest study, researchers looked at a World Health Organization (WHO) database of individual case reports, comparing data on Propecia users to those who used Avodart, a prostate drug with a similar mechanism of action.
The researchers found 356 reports of suicidality, and 2,926 reports of psychological adverse events in Propecia users. According to their findings, users of Propecia ages 18-44 had a 63% increased chance of suicidality, and more than four times the risk of psychological adverse events. However, those signals were not seen in other groups, and not even among older patients who took Proscar for prostate problems.
“In this pharmacovigilance case-noncase study, significant (return of results) of suicidality and psychological adverse events were associated with finasteride use in patients younger than 45 who used finasteride for alopecia,” the researchers concluded. “The sensitivity analyses suggest that these disproportional signals of adverse events may be due to stimulated reporting and/or younger patients being more vulnerable to finasteride’s adverse effects.”
Propecia Side Effects
While men generally take the medication to help improve their appearance and overall quality of life, the drug maker previously faced a number of Propecia lawsuits filed by men who allege that they have been left with permanent sexual complications, such as erectile dysfunction, decreased libido, genital shrinkage and problems with cognition.
According to allegations raised in the complaints, Merck has failed to adequately warn consumers or the medical community about the link between Propecia and sexual dysfunction, which may continue long after the medication is no longer used.
Prior warning information provided by the drug maker suggested that sexual dysfunction associated with the medication was rare, and that the problems resolve after use of the medication is discontinued.
Even after many men reported experiencing permanent sexual issues after Propecia use, Merck continued to provide information suggesting that the problems were temporary until the Propecia warning label was updated in April 2012.