FDA Alert Raises Concerns about Prescription Testosterone Treatments and Cardiac Complications
February 13, 2014
The products liability lawyers at Galfand Berger in Philadelphia have been following the recent developments regarding the safety concerns of prescription testosterone treatments. We are currently investigating potential lawsuits on behalf of individuals who have suffered adverse health consequences after taking these hormone replacement medications.
Testosterone is the male hormone produced in the testes. It is responsible for male growth and reproduction such as maintaining muscle mass and strength, bone density, sperm production, sex drive and fertility. Hypogonadism is the medical term for a low level of testosterone. Hypogonadism associated with a medical condition such as genetic failure or chemotherapy is the only approved use for prescription testosterone that is recognized by the Food and Drug Administration (FDA).
A decrease in testosterone production naturally occurs as men age leaving them with reduced sexual drive, decreased muscle strength, increased body fat, depression and lack of energy. In recent years, men have been trying to combat these effects of aging and the lower levels of testosterone by seeking treatment with testosterone medications. Many doctors are now more willing to prescribe the testosterone hormone replacement therapy for individuals beyond the scope of classic hypogonadism. Yearly prescriptions for testosterone soared by more than 5-fold from the year 2000 to 2011 with 5.3 million prescriptions being written in 2011.
Testosterone medication can be administered through a skin patch, topical gel or an injection. The most commonly prescribed testosterone medication is AndroGel, manufactured by AbbVie Inc. Some of the other frequently prescribed testosterone products include Axiron, Androderm, Testim, Depo-Testosterone, Fortesta, Testoprel, Striant and Bio-T-Gel.
FDA Investigating Serious Cardiovascular Risks of Testosterone Medications
With the publication of two recent studies showing that prescription testosterone treatments may increase the risk of heart attack, stroke or even death, the FDA issued a public safety alert warning consumers about the potential increased risk of cardiovascular events. Doctors are encouraged to use more caution when prescribing the medications taking the risks versus the benefits into consideration. Anyone taking the medication should discuss their treatment with their physician.
The most recent study that prompted action by the FDA was printed in the online scientific journal, PLOS ONE. The study, which was funded by the National Institutes of Health, analyzed medical data on over 55,000 patients. They found that men over the age of 65 with or without a history of cardiac disease were twice as likely to suffer a heart attack within the first 3 months of starting testosterone therapy. Men younger than 65 with a documented history of heart disease were also two to three times likely to suffer a heart attack.
The second earlier study, which was printed in the Journal of the American Medical Association, showed similar results. The findings indicated that older men had an almost 30 percent increased risk of heart attack, stroke and death after taking testosterone medications.
Currently, there are no warning labels on any of the testosterone drugs about an increased risk of cardiac complications. There are now several testosterone lawsuits filed against AbbVie, Inc. and Abbott Laboratories by men who claim they suffered heart attacks, strokes or mini-strokes after using AndroGel. The men also claim that the manufacturer knew about the potential cardiac risks, knowingly concealed this information, and failed to provide adequate warnings to the consumers. Our products liability lawyers will continue to follow any additional announcements from the FDA after their investigation is complete.
The Products Liability Lawyers at Galfand Berger: Dedicated to Helping Victims Injured by Dangerous Pharmaceuticals
If you or a loved one has suffered a heart attack, stroke or any other adverse cardiac side effect while taking a prescription testosterone treatment, contact the products liability lawyers at Galfand Berger as soon as possible. You may be eligible to recover compensation for your injuries by filing a testosterone lawsuit against the manufacturer of your hormone replacement drug. We maintain offices in Philadelphia, Reading and Bethlehem, PA and represent clients throughout Pennsylvania and New Jersey. Call us today at 1-800-222-USWA (8792) to schedule a free consultation with one of our personal injury lawyers or submit a free online inquiry.