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Entries in Side Affects (2)

Thursday
Jul122012

Baldness Drug's Sexual Side Effects May Be Long-lasting

Stephen Chernin/Getty Images(WASHINGTON) -- Men who take Propecia for baldness may experience sexual side effects that last for months to years, even after they stop taking the drug, a new study published Thursday in the Journal of Sexual Medicine suggests.

Researchers from George Washington University interviewed 54 men under the age of 40 who reported side effects for three months or more after taking Propecia, also called finasteride, to treat their hair loss.  None of the men reported having any sexual, medical or psychiatric problems before they took the drug.

Some of the men took the drug for a few weeks, others took it for years, but all of them reported side effects such as erectile dysfunction, decreased sexual drive, problems with orgasms, shrinking and painful genitals, even some neurological problems, such as depression, anxiety and mental fogginess.

For 96 percent of the men, the sexual problems lasted for more than a year after they stopped taking the drug.

"Our findings make me suspicious that this drug may have done permanent damage to these men," said Dr. Michael Irwig, the author of the study.  "The chances that they will improve?  I think it's lower and lower the longer they have these side effects."

Irwig cautions that it's possible that only men who were the most affected by the drug participated in the study.  Because he recruited his study participants through an online forum called PropeciaHelp, a group for men who have experienced persistent sexual side effects from the drug, he said the study may not have included men who have fewer or less pervasive side effects.

Finasteride works by blocking the conversion of testosterone into a more potent form, called DHT, which contributes to hair loss.  It was originally developed in 1992 by drug giant Merck as a treatment for enlarged prostates and sold as the drug Proscar.

Propecia was approved by the U.S. Food and Drug Administration in 1997, and at that time Merck noted that a few men reported sexual side effects during clinical trials of the drug.  On its website, the agency said those side effects were resolved when patients stopped taking the drug.

But the agency received more than 400 reports over 13 years from consumers reporting sexual dysfunction, and nearly 60 men reported that those side effects lasted longer than three months after the men stopped the medication.  In 2011, the FDA mandated a label change for Propecia and Proscar, warning that some patients reported erectile dysfunction that lasted after patients stopped taking it; in April, the agency updated the label to include reports of libido, ejaculation and orgasm disorders.

In a statement, Merck said no evidence has proved a causal relationship between Propecia and long-lasting sexual dysfunction.

"Merck believes that Propecia (finasteride) has demonstrated safety and efficacy profiles and that the product labeling appropriately describes the benefits and risks of the drug to help inform prescribing," the company wrote in the statement.

But researchers say many physicians who prescribe finasteride are likely not aware that the side effects of the drug may haunt patients for years.

"These things just get handed out left and right for any urinary symptoms," said Dr. Ryan Terlecki, an assistant professor of urology at Wake Forest School of Medicine, who has prescribed Proscar for some of his patients with enlarged prostates.

Terlecki said the findings about long-term side effects from the drug are alarming, but more research will likely be needed before doctors can know for sure that the symptoms are completely attributed to the drug.

Copyright 2012 ABC News Radio

Thursday
Feb232012

Qnexa Ruling Renews Debate About Its Risks and Benefits

FDA/iStockphoto/Thinkstock(WASHINGTON) -- The decision by a federal advisory panel to recommend Qnexa for approval by the U.S. Food and Drug Administration is drawing praise and criticism from obesity and diet experts, reflecting a still-hot debate on the need for additional tools to treat obesity.

The 20-2 decision recommending approval Wednesday came as a surprise to many experts. The FDA has not approved a weight-loss drug in the past 13 years and has withdrawn from the market many drugs due to concerns over heart risks and other side effects.

Qnexa was rejected by the agency in 2010 after a 10-6 vote against approval by the same panel, which included about half of the same members as Wednesday's.

But the panel this week agreed that the health risks of obesity and the benefits of losing weight outweighed the risks posed by the drug.

"The approval of Qnexa is a major step forward for the field of obesity treatment and is the result of advances in our understanding of the health consequences of obesity, and the resistance mechanisms that make it difficult to lose weight," said Dr. Louis Aronne, director of the Comprehensive Weight Control Program at New York Presbyterian Hospital.

Qnexa's rejection in 2010 was largely due to concerns over the potential for heart problems, birth defects and mental effects such as lack of concentration and fogginess for patients taking the drug.

The panel seemed to be moved this time by plans by the drug's manufacturer, Vivus, to minimize those risks through measures like labeling and an additional trial to investigate cardiovascular side effects.

But some experts say the side effects are still a major concern for a drug that will likely be sought by millions of people.

"This is far from a great drug," said Dr. David Katz, director of the Yale Prevention Research Center. "The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures. Approval of Qnexa would reflect that...desperation."

One-third of Americans are obese and have chronic, expensive health problems as a result -- diabetes, heart disease and arthritis, to name a few. Patients and doctors are often frustrated by the lack of middle-ground options between traditional recommendations for diet and exercise and the more extreme approach of bariatric surgery.

Patients and doctors aren't the only ones antsy for a solution. The FDA has faced mounting pressures from health care groups and patient advocacy organizations to take obesity more seriously as a condition worthy of pharmacological treatment. In a letter in September, the U.S. Senate Appropriations Committee directed the FDA to file a report by March 30, 2012 on the steps it will take to "support the development of new treatments for obesity."

Critics say the search for an anti-obesity drug is nothing more than a search for a "magic bullet" cure for obesity to eliminate the need for making difficult lifestyle changes.

"The approval of Qnexa feeds into a quick-fix approach to weight management," said Dr. Gerard Mullin, associate professor at Johns Hopkins School of Medicine. "The solution to the overweight-obesity epidemic lies not in another effortless 'quick fix' but in a painful but permanent lifestyle solution."

Qnexa is a combination of two drugs already approved by the FDA: phentermine, a stimulant that suppresses appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight loss as a side effect. Vivus recommends that the drug be prescribed as a part of weight loss plans that include diet and exercise.

Clinical trials so far show that the drug helps people shed 10 percent of their body weight, although patients regained some weight in the second year on the drug. It also seemed to have positive effects on blood sugar and blood pressure.

The FDA will decide whether or not to approve Qnexa by April 17. Although the agency usually follows the recommendations of its panels, the drug's fate is not assured. In 2011, a panel recommended the weight loss drug Contrave for approval, but the FDA declined to follow its advice.

Copyright 2012 ABC News Radio







ABC News Radio