QUESTION
Will Low T Drugs Be Recalled Due to the Potential Heart Risk Investigation by the FDA?
ANSWER
Although the FDA required new testosterone warnings in March 2015, requiring drug makers to provide information about the cardiovascular risks and to conduct further studies, there is no indication that the agency is considering a recall for “Low T” treatments or will be removing the drugs from the market.
A drug safety communication was issued by the agency on March 3, 2015, outlining new label warnings for testosterone drugs like AndroGel, AndroDerm, Testim, Axiron and other gels, creams, patches, injections and pellets.
In addition to warning about the potential risk of heart attacks and strokes, the FDA required the labels to indicate that testosterone drugs are only approved for use by men suffering from hypogonadism which has been verified by medical testing.
A testosterone recall would only be issued if the FDA determined that the risks associated with the medications outweigh any potential benefits provided. Based on the current studies, this does not appear to be the case.
Although studies have shown that certain men may face an increased risk of heart attacks and strokes, placing stronger warnings for consumers and the medical community would likely address the concerns. In addition, steps could be taken to ensure only men who have a true medical need for testosterone replacement therapy receive the medications.
FDA Testosterone Drug Investigation
The FDA launched an investigation into the safety of testosterone drugs in January 2014, following the publication of two studies.
The first study was published in the Journal of the American Medical Association (JAMA) in November 2013, which found that veterans with certain pre-existing heart problems were more likely to suffer a heart attack, stroke or sudden death.
The second study was published in the medical journal PLoSOne in January 2014, finding that some younger men with pre-existing heart disease and older men regardless of any pre-existing conditions may face double the risk of suffering a non-fatal heart attack on testosterone.
The prominent consumer advocacy group Public Citizen has called for the FDA to add a testosterone black box warning about the potential heart risk, which would place the risk information in a box featured prominently on the label.
While the agency’s did not require a black box warning, the most stringent warning the FDA can require, it did add new warnings regarding heart attack and stroke risks.
The March 2015 label changes came following an FDA advisory committee hearing in September 2014, during which advisors to the FDA determined that more studies needed to be conducted, and warned that testosterone products should not be used by men suffering the normal decrease in testosterone that comes with aging. The FDA has ordered testosterone manufacturers to conduct new clinical trials to better define the relationship between testosterone drug use, heart attacks and strokes.
After reviewing additional data from these studies, it is possible the FDA may take additional regulatory steps to protect consumers, including a risk mitigation program, which would require certain information to be provided to patients or possibly require physicians to take certain steps before they prescribe the medications. However, a recall for all testosterone drugs would not be warranted based on the available information.
Reduced Testosterone Sales and Prescriptions Likely
Although low T drugs are likely to remain on the market, it is widely expected that sales and use of the medications will drop dramatically after information about the heart risks are provided.
When they were first introduced on the market, testosterone drugs were considered a “niche” industry. However, amid aggressive promotions by the drug makers, use of testosterone drugs has increased five fold from 2000 to 2011, with more than 5 million prescriptions issued per year. Prior to information about the heart risks surfacing in early 2014, it was widely expected that testosterone sales would hit $5 billion by 2017.
Many men have received testosterone prescriptions for life-style reasons, seeking to restore the vigor and energy that may have diminished as a result of natural declining testosterone levels as all men age. Studies have suggested that the drugs are often prescribed without any testosterone testing or for men with levels that are generally considered normal for their age.
Once information about the heart risks is widely known, many physicians are likely to think twice before prescribing the drugs. In addition, most men without a true testosterone deficiency associated with a medical condition may decide for themselves that the benefits of the drug do not justify the risks.
Testosterone Recall Lawyers
The lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a legal claims against the drug makers as a result of the failure to provide adequate warnings about the potential testosterone heart risks.
To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.
No Comments • Add Your Comments