March 4, 2015

New labeling warns consumers about risk of heart attack and stroke

androgel_lawsuit_FDAThe Food and Drug Administration (FDA) issued new safety warnings to doctors and patients about elevated risks of heart attack and stroke when undergoing testosterone replacement therapy.  Specifically, the FDA warned only certain medical conditions warrant the use of testosterone therapy and that so-called “low T” products should not be used to fight the natural effects of aging.

The FDA cited the conclusions by some medical studies showing men undergoing testosterone replacement therapy to treat the side-effects of aging, dubbed “low T” by the pharmaceutical industry, were at an elevated risk of cardiovascular disorders leading to heart attack, stroke, and death.

The FDA approved testosterone therapy only for patients experiencing low testosterone levels due to medical conditions like hypogonadism, a disorder caused by problems with the testicles or pituitary glands making natural testosterone production difficult.  Hypogonadism and other similar conditions can be the result of genetic issues, the side-effects of chemotherapy, or an infection.  Drug manufacturers must now alter the labeling of their testosterone products to reflect the product’s intended use to treat only these medical conditions associated with low testosterone.

FDA-approved testosterone replacement therapy formulations include topical gels, buccal systems applied to the inner cheeks or upper gums, skin patches, and muscular injections.  The FDA does not recognize the benefit or safety of using these testosterone replacement products to treat the side effects of aging.  Patients have reported using testosterone replacement products to treat decreased sex drive and energy levels, but the FDA believes these symptoms are related to a man’s natural aging process not a testosterone deficiency.

Testosterone replacement therapy for “Low T” has come under a great deal of scrutiny by the FDA since the agency recognized the rapid increase in middle-aged men receiving testosterone treatments.  Between 2009 and 2013, the number of men undergoing “Low T” therapy surged 77% from 1.3 million to 2.3 million.  Men between the ages of 40 and 64 make up 70% of those receiving the prescriptions.

The FDA’s safety report notes the most common diagnostic code applied to the prescription of testosterone replacement products is testicular hypofunction, a rare disorder caused by damage to both testicals.  The FDA also uncovered that in one medical database reviewed at least 20% of patients diagnosed with hypogonadism had no testing performed to measure their testosterone levels.

Thousands of lawsuits across the country have been filed against companies like Abbot Laboratories and Actavis .  Plaintiffs allege they suffered heart attacks, stroke, blood clots, or congestive heart failure as a result of using “Low T” treatments like Androgel (produced by Abbot), Axiron, and Androderm (produced by Actavis).

If you or a loved one suffered a heart attack, stroke, blood clot, or other serious cardiovascular related injury or death you may be entitled to substantial compensation.  The Cochran Firm, D.C. is actively investigating claims related to injuries suffered while undergoing “Low T” treatments.  Our experienced and dedicated attorneys can help you recover compensation for hospital bills, lost wages, pain and suffering, and other damages.

We represent individuals on a contingency basis, meaning there are no legal fees unless we recover for you.  Because strict time deadlines apply when filing a Low T testosterone injury claim, please contact us at your earliest convenience.  To receive a free, prompt, and confidential case review call us at 202-682-5800 during business hours, or call 1-800-THE-FIRM (843-3476) 24 hours a day, or fill out a contact form online.