4265 San Felipe # 1000
Houston, TX 77027


FDA cautious on testosterone drug approvals


Table of Contents

Concerned about the safety of testosterone drugs, the U.S. Food and Drug Administration recently requested that a pharmaceutical company test the drug on an additional 70 patients before the agency revisits whether to approve it.

The news comes almost a year after the FDA released a safety advisory explaining that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.”

The FDA wrote on Jan. 31, 2014, “We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.”

Five months later, the FDA required manufacturers of FDA-approved testosterone products to add warnings about the risk of blood clots in the veins.

“Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE),” the FDA wrote on June 19, 2014. “The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.”

The FDA explained that the two public health releases concern two separate probes, writing, “Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014.”

The agency urges health care professionals and anyone who takes testosterone products and who experiences an adverse reaction to report the reaction to the FDA Medwatch program. Prompt medical treatment is, of course, the most important thing.

Keep in mind that the FDA does not approve all testosterone replacement drugs. It approves only those that treat low-t that is associated with a medical condition.

“Examples of these conditions,” according to the FDA, “include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.”

In the meantime, the product liability attorneys at Reich & Binstock continue to investigate claims of apparent drug-related injury brought to the law firm’s attention – testosterone drug-linked or otherwise.

There are a number of law firms one may approach to determine whether an injury that is perceived to be caused by the use of a drug rises to the level of a valid claim for compensation. Anyone who turns to Reich & Binstock will receive a free consultation from attorneys who have decades of experience in taking on pharmaceutical companies whose products are proven by personal experience to pose unreasonable risks to someone’s health. Reich & Binstock, which operates in all 50 states, also has a successful track record in this regard.

Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through the form located on this web page.

Contact Us For a Free Legal Consultation

There is never a fee unless we recover on your behalf.
Additionally, clients are not obligated to pay expenses if a recovery is not made.

Contact Us
*By clicking submit, you are providing express consent to be contacted by SMS, possibly using automated technology to the number you provided. If at any time you wish to opt-out of communication, please reply "STOP". Text "HELP" for help. Message frequency may vary. Message/data rates may apply. Submission of this form does not authorize the purchase of goods, services, or products. See the privacy policy/Terms and Conditions on the webpage.