Why have government regulators in Sweden and the United Kingdom required Merck & Co., the manufacturers of the top-selling male pattern hair loss drug Propecia, to warn men about dangerous, long-lasting sexual side effects while the U.S. Food and Drug Administration has not? Those two European countries acted upon the findings of medical research that linked Propecia use to erectile dysfunction, loss of libido and several other sexual problems, including impotence. The same conclusions have been reached by some U.S. researchers and all of this data is available to FDA regulators, who first approved Propecia in 1997.
The FDA has been notoriously slow in reacting to claims of defective drugs and medical devices and the same pattern seems to be emerging in the agency’s approach to Propecia. Similar situations have occurred in the paste in which it took increasing pressure from medical research findings, a wave of lawsuits from victims of dangerous side effects and huge volumes of adverse event reports to the agency to spur officials into action to protect the consumer. The consumer advocate organization Public Citizen, for instance, has accused the FDA of being responsible for “thousands of deaths” for not moving faster to ban controversial painkillers. Learn more about a possible Propecia permanent impotence lawsuit
Merck, which initially stonewalled claims that there could be lasting sexual problems from the use of the Propecia while continue to sell the product to millions of men eager to halt their approaching baldness, has slowly backtracked on some of its statements. After first denying that there were serious sexual side effects the company changed its position to say that there could be some side effects in rare cases. Then it changed again to say that if there were serious side effects they would be reversed if the treatment was discontinued.
Even now there seems to be a two-faced approach. The company backed off in the United Kingdom and Sweden by acknowledging in warning labels that there might be long-term problems. The language used in the United States does not carry the same drastic message. In Australia there is no warning of possible impotence.
The FDA, as usual, is moving slowly. It has refused calls to ban Propecia, but has required Merck to change its labeling to reflect some of these concerns about sexual side effects. In the meantime, lawyers for plaintiffs who have filed Propecia lawsuits are gathering evidence that will determine whether they will be able to substantiate their claims that Merck was aware of these dangerous side effects and failed to properly warn consumers and government regulators.