FDA: Testosterone Drugs Linked to Deadly Heart Attacks
The FDA has released a safety announcement to warn men who have used testosterone drugs of the increased risk of heart attack and stroke. Unfortunately, this news may come too late for many patients and their family members. The Sanders Firm sympathizes with victims of dangerous drugs and would like to extend an invitation to schedule a free, no-obligation case review with our drug injury lawyers. If you’ve used testosterone drugs, you may also wish to speak with your doctor about safety concerns, given the alarming warning from the FDA.
Clinical studies inform new labeling requirements
The recent safety announcement serves as an update to a previous warning issued by the FDA on January 31, 2014. The agency notes that the safety and benefits of low-T drugs are unclear when these medications are used for men who have low-T due to the natural processes of aging. This holds true even if the patient exhibits symptoms of low-T. The FDA is cautioning doctors and patients that the only men who should be prescribed testosterone drugs are those who have clinically documented low-T levels due to specific medical conditions.
These medical conditions are primary or secondary hypogonadism that result from the following:
- Disorders of the testicles (such as damage from chemotherapy or radiation therapy)
- Pituitary gland disorders
- Brain disorders
In addition to these warnings, the FDA is requiring manufacturers of low-T drugs to update their labeling. The new labeling must reflect the FDA-approved usage of these drugs and it must state that these drugs may increase the risk of suffering a heart attack or stroke.
The FDA safety announcement includes information intended specifically for patients considering these drugs. The agency notes that it is natural for a man’s testosterone levels to decrease gradually with age, and that the aging process naturally lends itself to symptoms such as lower energy levels and sexual function problems. However, there is not yet an accepted medical consensus regarding whether these symptoms are in fact due to low-T or are merely caused by the natural aging process.
This means that it isn’t yet known if aging men should take low-T drugs, nor if they can do so safely. The FDA further urges patients to speak with their healthcare providers, read the patient information leaflet carefully, and seek medical attention immediately if they develop chest pain, shortness of breath, slurred speech, or weakness on one side of the body, or other symptoms of heart attack or stroke.
Consulting lawyers regarding testosterone drug injuries
Unfortunately, far too many men have already fallen victim to the aggressive marketing techniques of low-T drug manufacturers. The legal team at The Sanders Firm has over 45 years of trial experience and has earned a reputation for being aggressive litigators with an excellent track record of successful case outcomes for our clients.
We understand that it’s impossible to put a price on your health. But if you’ve been injured by testosterone drugs, our lawyers can help you hold negligent manufacturers responsible for their recklessness. By filing a lawsuit with the help of our firm, you can demand compensation for your medical bills, lost wages, pain and suffering, and other losses.
Schedule your free case review with a testosterone injury lawyer today by calling The Sanders Firm at 888-660-3714.
- FDA, FDA Drug Safety Communication, http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
- WebMD, FDA Orders Warning Labels on Testosterone Drugs, http://www.webmd.com/men/news/20150304/warning-labels-testosterone