FDA Orders Drug Makers To Add Heart, Stroke Warnings To Testosterone Drugs
The move is in response to controversial marketing of the drugs in recent years to help fight the effects of aging in men.
The Wall Street Journal's Pharmalot:
FDA Warns Testosterone Drugs Can Increase Heart Risks
Following months of deliberation, the FDA is now requiring drug makers to add information on product labeling about the possible increased risk of heart attacks and strokes associated with low testosterone treatments. And the agency is also cautioning these medications have not been shown to help men with low testosterone levels reverse the aging process. The move comes after sustained controversy over the cardiovascular safety and allegations of inappropriate marketing of these widely prescribed drugs, which have attracted sustained regulatory scrutiny as a result. Testosterone treatments have, at times, been widely promoted to help reverse aging, but safety concerns prompted heated debate amid dueling medical studies. (Silverman, 3/3)
FDA Mandates Tougher Warnings On Testosterone
The Food and Drug Administration said Tuesday that it is requiring drugmakers to warn patients that testosterone products may increase the risk for heart attacks and strokes. Testosterone replacements are approved to treat men with low testosterone related to medical problems, such as genetic deficiencies, chemotherapy or damaged testicles. But the level of the hormone can fall as men grow older. And testosterone is increasingly being prescribed to men to stave off aging, something the agency never approved. Doctors and specialized clinics have jumped on the bandwagon, offering testosterone replacements to treat what some refer to as "Low T." (Stein, 3/3)
Earlier KHN coverage: Low T Business Is Booming, Despite Questions About Risks (Varney, 4/28/14)