FDA Announces Investigation into Testosterone Drugs

FDA Announces Investigation into Testosterone Drugs

Posted By The Maher Law Firm || 25-Feb-2014

122399155The U.S. Food and Drug Administration (FDA) recently announced they would be investigating the safety of testosterone drugs after two studies indicated an increased risk of cardiovascular events among men taking the hormone. The agency cautioned men from abandoning their drug routine without consulting their physician first, and warned doctors to follow prescribing recommendations carefully.

Testosterone is commonly referred to as the male sex hormone. It plays many roles in men's health-from changes during puberty to sexual function and even metabolism. It is responsible for masculine characteristics and growth in men. Drugs like Androgel, Depo-Testosterone, and Axiron are testosterone replacement drugs that can be applied through transdermal patches, injections, and gels. All of these are included in the FDA investigation.

These drugs may be prescribed for men who have low testosterone for a variety of reasons including those who no longer produce testosterone due to chemotherapy or genetic problems. Problems with the pituitary or hypothalamus glands could also lead to hormonal imbalance and result in a prescription for testosterone.

Studies indicate potential risks

The FDA cited two separate studies in their safety announcement. Both played a role in the FDA's decision to investigate the drugs.

The first study was published in the Journal of the American Medical Association (JAMA) in November 2013 and was an observational study of older men being treated within the VA health system. The men included in the study all had low serum testosterone. All of them underwent coronary angiography, an imaging test of the vessels of the heart, to determine their risk for coronary artery disease. While some of the men were on testosterone treatment, others were not.

Among the men receiving testosterone treatment, there was a 30 percent increased risk of heart attack, stroke, and death when compared with the men who weren't on the hormone treatment.

In the second study, published more recently in the journal PLOS One, researchers found an increased risk of heart attack among both older and younger men with pre-existing heart disease on prescription testosterone replacement.

The study found men 65 and older had a doubled risk of heart attack in the first 90 days of a prescription testosterone regimen. For the younger study participants, the risk was increased two- to three-fold in the first 90 days. Among the younger participants without pre-existing heart disease, there was no increased risk.

Are you taking testosterone?

The FDA warned patients on a testosterone regimen to speak with their physician before changing anything about their dosage routine. It says that despite the warnings about these drugs, men should not make a decision to stop treatment without consulting their doctor first.

For doctors, the FDA warns these drugs are only approved for use with men who have low testosterone levels in association with a medical condition. Patients with low testosterone levels without an associated medical condition are not to be treated with these drugs.

The FDA also says that physicians should weigh the benefits of the drugs with the potential risks, knowing their patients heart histories and the seriousness of their medical conditions.

The FDA did not indicate when their investigation would be complete.

Dangerous drugs are often not detected until after numerous patients have experienced adverse health effects. In some cases, it seems patients end up being the guinea pigs for the drug makers. Drug makers have a legal responsibility to make and market drugs that are safe and effective when use as directed and to provide adequate warnings of known risks associated with a prescription drug. When they fail to fulfill their legal responsibility, they should be held accountable.

Categories: Dangerous Drugs
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