FDA to Decide If Testosterone Meds Boost Heart Attack Risks

The Food and Drug Administration (FDA) has decided to hold a special advisory committee meeting to discuss the potential cardiovascular risks posed by testosterone products. This meeting, to be held on September 17, 2014, will be spent examining two recently released trials that indicate that testosterone products may increase the risk of heart attacks in men.

At this advisory meeting, the FDA Bone, Reproductive, and Urologic Drugs panel and the Drug Safety and Risk Management committee will jointly discuss what implications these studies have for consumers and the general safety of testosterone products.

This safety reassessment is the culmination of a months-long investigation by the FDA. The agency has been researching claims made in the testosterone market and the safety of such products. The FDA has already put a warning on all testosterone drugs about blood-clot risks posed by these products. Depending on the outcome of these hearings, the market may be more tightly regulated or some products could even be banned.

Concerns about Testosterone Medications

In recent years, men have been buying testosterone medications in increasing amounts. The drugs for low testosterone count, or hypogonadism, are intended to increase sex drive, improve mood, and strengthen muscle tone. While testosterone medications have been advertised as a panacea for any male problem, the medications for “Low T” may pose serious risks. As the testosterone market is currently valued at $1.6 billion and is expected to grow to $5 billion by 2017, it is important for the FDA to take an active role in determining the health impact of these drugs.

A study of 55,000 men taking prescribed testosterone medications in the United States found that in the first 90 days using testosterone drugs, 1 in 167 men aged 65 or older could suffer a heart attack. These risks increased to 1 in 100 men under 65 for those with pre-existing heart conditions. These risks are more than double the normal risk for men in this age bracket. There were nearly doubled risks for younger men with previous risk factors for cardiovascular problems.

Many doctors have expressed concerns about these medications, and the FDA is taking these concerns seriously. However, the risk may be mitigated by other factors. The solution to make these drugs safer may be in requiring more stringent patient testing before starting the medication.
Source:

http://www.fiercepharma.com/story/do-testosterone-meds-boost-heart-attack-risks-fda-asks-advisory-panels-weig/2014-07-22?utm_medium=nl&utm_source=internal