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Merck Failed to Adequately Warn That Propecia is Associated With Permanent Impotence, Erectile Dysfunction, Depression, Endocrine Crash and Other Harmful Side Effects

The Levensten Law Firm is currently investigating the filing of Propecia lawsuits against Merck for its failure to adequately warn of Propecia’s harmful side effects. Studies show that Propecia is associated with permanent impotence, erectile dysfunction, depression, endocrine crash and other harmful side effects.

By way of background, Propecia is marketed to treat male-pattern baldness which is caused when dihydrotestosterone (DHT), a hormone related to testosterone, stops hair follicles from producing. DHT causes approximately 50% of males to bald as they age. Propecia is very expensive, and costs close to $2.00 per dose. For Propecia to work, it must be taken daily. Propecia is Merck’s blockbuster cure for baldness. Although most insurance plans don’t pay for Propecia, it generated approximately $447 million for Merck in 2010.

Research available to Merck for many years showed that Propecia causes a statistically significant number of sexual adverse events in men. A 2003 study in the Journal of Urology studied 3,040 men, ages 45 to 78. 15% of the men on finasteride (the generic name for Propecia) suffered new sexual side effects in the first year, compared to only 7% of the study subjects who weren’t on finasteride (Propecia). Hunter Wessells, M.D., chairman of the department of urology at the University of Washington School of medicine, was the lead investigator, and concluded, “there were real, ill effects from the drug… In some men, finasteride (the generic name for Propecia) caused erectile dysfunction; in others it decreased ejaculate volume; in others it reduced libido.”

As the problem in men using Propecia emerged, Merck exacerbated the problem by urging patients to stay on Propecia, stating the side effects lessen over time. The fine print in Merck’s label claimed that the side effects usually stop over time and disappear entirely in men who discontinue the drug. For many unfortunate victims, the Propecia side effects didn’t subside and were permanent. Merck only tells patients to quit taking the drug if there is no improvement, but by that time, it can be too late. Additionally, Merck failed to tell patients in its label that among the patients who dropped out of Dr. Wessells study, only half saw full resolution of their symptoms six (6) months after discontinuing the medication. Half of the patients who dropped out did not get better.

Cases involving men who discontinued Propecia but experienced persistent sexual dysfunction continued to grow at an alarming rate. Researchers at George Washington University and the Greater Baltimore Medical Center proceeded to study a group of victims of post-finasteride syndrome (PFS). A board certified endocrinologist found 71 men who were in good physical, psychological and sexual health before they took finasteride (the generic name for Propecia). It’s reported that after taking the drug, 90% suffered from low sexual desire, erectile dysfunction and decreased arousal – after being free of finasteride for 40 months on average. It was further reported that one man did not improve after being off the drug for 11 years.

To make matters worse, some men who discontinue the drug are experiencing an “endocrine system crash.” This is when the symptoms return more severe than ever, but accompanied by new ones such as hot flashes, extreme fatigue and changes to the structure of the penis and scrotum, which begin to shrink. The libido can vanish completely.

Studies also show that finasteride (the generic name for Propecia) can alter a man’s brain chemicals which play a role in reducing anxiety, enhancing memory, regrowing brain cells and helping people sleep. Two studies have shown that finasteride may cause the onset of depressive symptoms. Last year, researchers in Germany found that the drug inhibits the growth of new neurons in the brains hippocampus.

In 2008, the Swedish regulatory authorities required Merck to change Propecia’s label to include reports of persistent erectile dysfunction after discontinuing the drug. Italy and the UK then required similar label changes as a condition of further marketing the drug in those countries. The FDA required Merck to add adverse event reports to the postmarketing section of Propecia’s label, but Merck knows these changes are not enough to adequately warn of the risk.

The Lawyers at the Levensten Law Firm believe that the risk of permanent sexual dysfunction should appear in a black-box, let alone the warnings or precautions section of the label. Clearly, a physician will conclude that the risk of endocrine crash outweighs the benefit of treating male-pattern baldness. Certainly, no patient would choose hair over impotency. Still, people question why Merck has informed European countries about persistent sexual side effects after discontinuation, but hid it from the United States and Canadian market. We believe that Merck put profits over safety in an attempt to protect its block buster drug.

On April 19, 2011, faced with new research and Propecia class action lawsuits, Merck finally updated the label to include reports of erectile dysfunction that continued after discontinuation of Propecia. Incredibly, Merck continues to deny a causal relationship between Propecia and erectile dysfunction. This is truly a public health crisis in men as Merck cannot reliably estimate how many men are victims of Propecia’s harmful side-effects. The same problems are being found with Proscar, the brand of finasteride prescribed for prostate enlargement.

If you took Propecia and are suffering from sexual dysfunction, including impotence and/or erectile dysfunction, and are seeking legal representation, you may feel free to contact the lawyers at the Levensten Law Firm for a free case evaluation. After a review of your case, we will promptly advise you if the Levensten Law Firm can file a Propecia lawsuit on your behalf. As your claim is governed by a statute of limitations which sets deadlines for the filing of your lawsuit, you should act promptly to protect your rights.

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