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FDA Announces Labeling Change for Low Testosterone Medications; Warns of Increased Risk of Heart Attack and Stroke with Use

April 1st, 2015

The Food and Drug Administration (FDA) recently announced that they will be increasing restrictions on the labeling and sale of medication aimed at treating low levels of testosterone in adult men. For years, drug manufacturers have marketed medications such as Androgel, Axiron, and many others, as a “cure” for many of the symptoms associated with the normal aging process of adult men.

According to these advertisements, problems such as lowered libido, erectile dysfunction, decreased energy levels and loss of muscle tissue, could be blamed on a condition called “Low-T.” The truth of the matter is that “Low-T” is not a real medical condition; it is one that the pharmaceutical companies made up to make money. The sale and advertising of these medications is another example of drug manufacturers creating a false medical condition and playing on the insecurities of men in order to sell medication and boost prescription numbers.

In 2013 alone, the sale of testosterone replacement therapies and Low-Testosterone medications generated nearly $2 billion in revenues, up from only $324 million a decade earlier in 2002. In addition, the numbers of Low-T prescriptions issued by doctors rose from 1.3 million in 2010, to over 2.3 million in 2013.

What the drug manufacturers did not share with these patients or their doctors, is that these medications should not be consumed by men who are experiencing lower levels of testosterone as a part of the natural ageing process, as it can dramatically increase a patient’s risk of suffering a heart attack or stroke.

In reality, these types of testosterone therapy medications should only be prescribed to men suffering from a very specific medical condition known as Hypogonadism. Hypogonadism is caused by a disorder in the brain, pituitary gland or testicles, and can lead to dangerously low levels of testosterone in some older males.

Recent findings released by the FDA and several other national health organizations indicate that prescribing these medications to adult men that are not suffering from Hypogonadism may dramatically increase a patient’s risk of suffering a heart attack or stroke. Here are some concerning statistics regarding the increased risk of heart attack and stroke among men who have taken Low-T medication without a proper medical diagnosis:

  • In 2013, the Journal Of American Medical Association (JAMA) found that men who were taking testosterone replacement drugs were up to 30% more likely to suffer death, heart attacks or strokes as compared to men of the same age that were not taking such medication.
  • The National Institute of Health (NIH) also released a study that found that men taking Low-T medications past the age of 65 had nearly double the rate of heart attacks as compared to men of the same age that were not taking such medication.
  • The FDA estimates that 2.3 million men were taking Low-T medication in 2013. Of that 2.3 million, only 25% of patients had been medically diagnosed with low levels of testosterone.

As of March 3rd, 2015, The FDA will now require that patients undergo laboratory testing confirming the presence of Hypogonadism, or similar medical conditions, before prescribing these types of testosterone replacement medications. It will also will require drug manufacturers to clearly state the associated risks of taking these drugs without the proper medical diagnosis, and “change their labeling to clarify the approved uses of these medications.”

By advertising Low-T medication as safe for use in millions of men who needed no such hormone replacement therapy, drug manufacturers potentially put millions of consumers at risk. These potentially dangerous drugs have affected many healthy men.

If you or someone you love has suffered a heart attack or stroke after taking any Low-T or testosterone replacement medications, call The Yost Legal Group right away at 1-800-YOST-LAW (967-8529).

At The Yost Legal Group, Baltimore Product Liability and Defective Drug law firm, we take pride in standing up to major drug companies on behalf of our clients. When you call our firm, you will speak with an experienced Baltimore, Maryland Defective Drug attorney that will help you understand the details of your case. We know how to fight the insurance companies and major drug manufacturers in order to secure the maximum compensation for your serious injuries.

The Yost Legal Group works closely with you to gather the medical evidence needed to support your case, and we offer a free consultation to evaluate your claim.

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