Tuesday, January 3, 2012

Sexual Side Effects the Cause of Propecia Lawsuits


Propecia, a treatment for male pattern-baldness, is currently facing lawsuits that address the drug's serious side effects. Since 1997, Propecia (finasteride, 1 mg) has been marketed as the world's first hair-loss remedy available as a pill. When the medication first became available, Merck, the drug's manufacturer, warned consumers of a low risk of erectile dysfunction and other sexual side effects. However, studies conducted over the last 14 years have revealed that Propecia's side effects are more plentiful and persistent than first reported.

Lawsuits Against Propecia Increase

As more plaintiffs file Propecia lawsuits, news has spread regarding the drug's side effects. While all medications have possible side effects, medical experts explain that the issue is whether a drug's benefits outweigh the risks. In a case such as Propecia, the cons were not fully understood or disclosed, so patients made decisions without fully understanding potential risks to their health.
In a recent Los Angeles Times article, Dr. Valerie Ulene, a board-certified specialist in preventative medicine, expressed her concern over Propecia. Dr. Ulene encourages a risk analysis of the drug's benefits – reducing bald spots, slowing hair loss, and improving hair's appearance – compared with Propecia side effects, which include male breast cancer, impotence, and an increased risk of high-grade prostate cancer. Ulene's opinion is that the possibility of serious, long-term repercussions is what has prompted so many Propecia lawsuits.

Lawsuits Address Liability
A major question is if Propecia labeling is faulty, and several lawsuits question whether Merck adequately disclosed all potential side effects. However, the issue runs deeper than just one drug or manufacturer: Dr. Ulene explains that drug labels are often overwhelming for patients. The FDA-required package insert, which contains information from how the medication works to what to do in the case of an overdose – is very comprehensive – so much so that it can be confusing.
For example, the Propecia package insert summarizes the results of several clinical trials, including the fact that 1.2% of men stopped taking Propecia due to sexual side effects. However, this information is buried within the informational pamphlet, hampering a patient's ability to comprehend and absorb all the information presented.
Dr. Ulene states that the FDA understands the problem with drug package inserts and other published information regarding side effects. The organization has already conducted several studies on how to improve communication with the public, and plans to revise requirements for drug advertising.