February 6, 2017
President Donald Trump takes a few prescription medications including Propecia (finasteride), a hair loss drug linked to side effects, the New York Times reported.
Dr. Harold N. Bernstein, Trump’s personal physician since 1980, gave four telephone interviews to the Times and discussed the President’s medications. In addition to Propecia, the President takes baby aspirin, Crestor (rosuvastatin) for high cholesterol and antibiotics for rosacea — a skin ailment.
This is not the first time Merck’s Propecia has been in the spotlight.
In 2011, the U.S. Food and Drug Administration announced it would require label warnings for “erectile dysfunction after stopping use of the drug.”
In 2012, the FDA expanded the list of reported sexual adverse events to include: libido, ejaculation and orgasm disorders. The agency said these problems may continue long after patients stop using the drug.
Merck sells finasteride as Propecia in a 1 mg formula and Proscar in a 5 mg formula. The FDA first approved Proscar in 1992 to treat an enlarged prostate — also called benign prostatic hyperplasia.
Propecia hit the market in 1997, after Merck discovered some finasteride study participants regrew some lost hair. The drug maker marketed it to younger men with male pattern baldness.
Studies Link Propecia to Impotence
The same year the FDA approved Proscar, researchers published an article in the New England Journal of Medicine. The article showed men who took the drug had a higher incidence of loss of libido, ejaculatory disorders and impotence than those who did not.
Because older men with enlarged prostates were already likely to have sexual dysfunction, there was little discussion about these results.
Then in 1998, two Propecia trials included men 18 to 41 who took the drug or placebo. More than 1,500 men participated in the study.
Study authors Keith D. Kaufman and colleagues found the drug slowed hair loss and increased hair regrowth. But, it also found the rate of sexual dysfunction in Propecia users was double that of the placebo group.
In addition to sexual side effects, Propecia and Proscar may also increase the risk of depression, high-grade prostate cancer and male breast cancer, according to medication labels.
Propecia Side Effects Lead to Lawsuits
Propecia’s side effects led some men to file lawsuits.
Currently, there are close to 1,000 federal lawsuits pending in multidistrict litigation in New York as of January 17, 2017, according to a report from the Judicial Panel of Multidistrict Litigation.
In its Security and Exchange Commission (SEC) filings, Merck reported about 1,300 Propecia and Proscar lawsuits for the quarter ending September 30, 2016.
“Plaintiffs…allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia and/or Proscar,” the report said. “Approximately 50 of the plaintiffs also allege that Propecia or Proscar has caused or can cause prostate cancer, testicular cancer or male breast cancer.”
Merck intends to defend against these claims.
In the case of Trump, Propecia seems to be working.
“He has all his hair,” Bornstein, who also uses the drug, told the Times. “I have all my hair.”
Bornstein did not comment on any Propecia-related side effects Trump may have suffered. But he told the Times the drug may keep the President’s prostate specific antigen (PSA), a marker for prostate cancer, at a low level of 0.15.