FDA weighs risks of testosterone replacement medicines
Men have been aging for . . . well, forever. What's newer is the great increase in the apparent need for testosterone replacement medication - often without tests of a man's current condition and in the wake of commercials by pharmaceutical companies on TV programs watched by 40-to-60-year-old men.
Men have been aging for . . . well, forever.
What's newer is the great increase in the apparent need for testosterone replacement medication - often without tests of a man's current condition and in the wake of commercials by pharmaceutical companies on TV programs watched by 40-to-60-year-old men.
Beyond the euphemistic and delicate discussion of sexual dysfunction or waning verve is the concern that such medicine increases the risk of heart attacks and strokes.
In January, the U.S. Food and Drug Administration issued a "safety announcement," to say it was "investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products."
The agency said patients should not stop taking prescribed products without talking to a health-care professional, but also said, those "professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment."
On Wednesday and Thursday in Hyattsville, Md., the FDA will hold a combined meeting of two advisory committees to look at who is being prescribed such medication, assess the cardiovascular risks and then consider an application for an oral testosterone replacement medication. Current treatments - which are a different category than drugs such as Viagra - have been administered as gels or injections or implants in the hip.
In material released in advance of the meeting, the FDA cited research and studies that suggest from 2009 to 2013, sales of testosterone replacement therapy increased 65 percent. The patients prescribed testosterone medication increased from 1.3 million in 2010 to 2.3 million in 2013. The FDA said it appeared too many men were being prescribed those drugs without the required testing.
The FDA is not required to follow the recommendations of advisory committees, but it usually does. Besides patients and doctors, the outcome will be of great interest to at least the 12 pharmaceutical companies that joined forces to write a paper submitted to the advisory committees.
Auxilium and Endo Pharmaceuticals are two Philadelphia area companies who sell those products and joined the industry effort.
Auxilium laid off about 200 people last week, which was 30 percent of its employees, citing declines in sales of its erectile dysfunction medications as one factor. Spokeswoman Keri Mattox Tuesday declined to say what further restrictions on the drugs would mean to Auxilium, but said, "We are looking forward to participating in the FDA Advisory Committee meeting and to an active and engaged discussion about testosterone replacement therapy."
University of Pennsylvania endocrinologist Peter J. Snyder is scheduled to speak at the hearing. Jeanmarie Perrone, an emergency room doctor at Penn and an expert on toxicology, is on the Drug Safety and Risk Management Advisory Committee, as is Tobias Gerhard, of the Rutgers University Ernest Mario School of Pharmacy. Merck & Co.'s Keith Gordon, who works from Upper Gwynedd and whose expertise is reproductive physiology, is the industry representative on the Bone, Reproductive and Urologic Drugs Advisory Committee.
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