New FDA Warnings Announced for Testosterone

By August 12, 2014Dangerous Drugs

New Food and Drug Association warnings requirements have been announced for testosterone products.  Testosterone treatments including AndroGel were marketed towards men as a way to have more energy, feel younger and improve sex drive. Unfortunately, while the benefits of testosterone therapy were heavily touted by manufacturers of these products, there was insufficient information provided to consumers about the risks that testosterone creams and other therapies could present. 

Understanding FDA Warnings

FDA warnings may be required on certain medications and medical devices that could endanger patients.  The FDA will specify what type of warning a product must contain and how the FDA warnings need to be formatted. For example, if a product is especially high-risk, the required FDA warnings may need to be in a black box on the product (these are called “black box warnings.”)

Testosterone therapies already include a warning telling patients about the potential risks of the treatment.  The existing warning label indicates to patients that there is a danger of blood clots developing as a result of the medication use. The warning indicates that the clots are caused by an elevated level of red blood cells, which the testosterone therapy can cause to occur.  The condition that causes these problems that the testosterone labels warn about is called polycythemia.

Unfortunately, this warning label is not sufficient to actually alert users of the testosterone medications about the full extent of the dangers they face.  The FDA has received adverse event reports of patients using testosterone products who developed blood clots that were not related to polycythemia. As a result, WebMD indicates that the FDA wants a more general warning alerting patients that blood clots are a very real possibility.

FDA Warnings Detail Risks of Testosterone Therapy

Because of the many adverse event reports and because blood clots are extremely dangerous, the FDA will now require manufacturers of testosterone therapies to revise their labels to alert patients to the general risk of blood clots.

FDA warnings allow a consumer to make an informed choice about whether the benefits of a drug or a medical device outweigh the potential risks and dangers.  In the case of testosterone, blood clots are a very serious and potentially fatal complication and the patients who use these products deserve to know about the danger.

Blood clots can cause a stroke to occur or could cause a pulmonary embolism if the clot travels to the lungs.  The consequences can be fatal.  Patients who take long-haul flights or who sit for long periods of time are especially at risk of deep vein thrombosis (DVT) and need to know that testosterone therapy exacerbates the risks.

The revisions to the FDA warnings required on testosterone products address only the risk of blood clots.  The FDA also announced back in February that the agency would be conducting a broad review and assessment into whether testosterone medications are safe for use or not. The review of the testosterone medications was launched after a study indicated that the medications could significantly increase the risk of heart attack.

FDA warnings protect consumers and if a medication does not provide enough information to customers about the risks, the drug manufacturer can be held legally liable. An experienced St. Louis defective drug lawyer at Carey, Danis & Lowe should be consulted by victims of dangerous medications. Call or contact us online today to talk with a member of our legal team today.

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