Consumer Advocates Push FDA for Black Box Warning on Testosterone Drugs

A consumer advocacy group, Public Citizen, is asking the U.S. Food and Drug Administration (FDA) to mandate that a new black box warning label be placed on testosterone drugs. This is because of increasing evidence that men are at risk of suffering a heart attack, stroke or death. This follows on the heels of another product lawsuit related to male aging, Propecia, used to counteract balness.

Of all warnings that can be placed on a medication, the black box is the most stringent. These are designed to draw special attention to a medication’s risks when they can cause serious or life-threatening injuries.

Last month the FDA began reviewing the safety of testosterone drugs, after recent studies indicated a higher rate of heart attack. One study, conducted by the U.S. Veterans Affairs (VA), found there was a 30 percent increased risk in older men who take the medication. In another federal study, the risk of heart attack was found to be doubled in men ages 65 and up.

However, Public Citizen suggests the risks may have been known a couple of years ago. They believe that action should have been taken by the FDA back in 2010. Their push to reconsider the safety of these medications is during a time when testosterone drugs are becoming increasingly popular.

But they aren’t the only ones raising concerns. Specialists from the Endocrine Society believe more needs to be done to determine if the risks outweigh the benefits.

When Drug Safety Could Lead to Legal Action

Known or unknown at the time of manufacturing a drug, if it’s found to be unsafe to consumers, it could lead to black box warnings. In some cases it may even result in a drug getting pulled from the market. But for someone to seek legal action against the pharmaceutical company, there would need to be evidence it was the cause of someone suffering serious or fatal injuries. To learn more about one’s rights to pursue a claim, contact an attorney at Gacovino, Lake & Associates (800) 550-0000.

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