A recent medical study suggests that the manufacturer of Propecia did not accurately report known issues connected to the male pattern baldness treatment. This new research reports that Propecia clinical trials may have been “systematically biased.”

Researchers from Northwestern University’s Feinberg School of Medicine conducted their own analysis of adverse events involving Propecia and began to probe the validity of the drug’s clinical trials. The researchers published their new findings in the April edition of JAMA Dermatology, a medical journal.

According to the Chicago-based researchers, the majority of Propecia clinical trials were allegedly of poor quality and heavily influenced by the drug’s manufacturer, Merck Sharpe & Dohme.

This new Propecia study scrutinized 34 clinical trials and two meta-analyses. The results demonstrate a trend by the manufacturer of under-reporting possible Propecia side effects, as well inadequate reporting of safety procedures.

The Propecia study states:

“Of 34 studies, none met the criteria…for adequate safety reporting. Most provided no description of the duration or severity of signs or symptoms of sexual dysfunction and failed to distinguish between mild, reversible sexual dysfunction and severe, permanent sexual dysfunction.”

Of the 34 studies, 19 had partially adequate safety reporting, 12 had inadequate safety reporting, and three of the Propecia studies involved in the clinical trials reported no adverse drug side effects. The Northwestern University researchers found that over 53 percent of the clinical trial articles had authors with a conflict of interest, while 56 percent received funding from Merck.

Finally, this April Propecia report states that 26 of the 34 Propecia clinical studies evaluated the Propecia side effects in research participants for only a year or less. Additionally, only 31 percent of the men studied in the clinical trials met the inclusion criteria that Merck submitted to the FDA for drug approval.

Propecia Side Effects

Propecia is a popular benign prostatic hyperplasia (bph) and androgenic alopecia (more commonly known as male pattern baldness) treatment that has been used by hundreds of thousands of men across the nation. Since being introduced into the American  drug market, Merck Sharpe & Dohme has sold about one million Propecia prescriptions within the U.S. alone, and has been found to be an effective drug by many consumers.

However, according to recent Propecia side effects studies and Propecia lawsuits, this finasteride-based drug has been linked with several sexual health complications, including:

• Erectile dysfunction (ED)
• Loss of sex drive
• Impotence
• Low libido
• Inability to orgasm

In April 2012, the FDA required the manufacturer of finasteride products to make a mandatory Propecia drug label change. This label change would include a warning to consumers about the “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.”

While Merck did comply with this FDA mandates and includes a Propecia sexual dysfunction warning on the drug’s labeling, the drug label also features related claims that serve to reassure consumers and doctors that the Propecia side effects were temporary and would resolve themselves once a man stopped taking the finasteride drug. This reassurance may have underplayed the risk of Propecia sexual dysfunction to male consumers.

Because of these alleged Propecia side effects and supporting research, Merck is currently facing over 1,200 finasteride lawsuits. These legal complaints are generally filed by men or their significant others after the patient suffered one or more of the above listed Propecia complications and injuries.