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androgelA wave of lawsuits is expected against the manufacturers of AndroGel a prescription drug for low testosterone called “low T” in television advertising. Recent medical studies have concluded that AndroGel can double or triple the risk of heart attack. Further, the idea of treatment of “low T” is a marketing gimmick by drug companies seeking huge profits. The advertisements recommend AndroGel for tiredness and loss of libido. There is little scientific evidence that AndroGel is beneficial for treating such symptoms. “Low T” as a medical condition was invented by advertisers for the drug.

All drugs have side effects and drug manufacturers are not liable for side effects of useful drugs if they provide proper warnings on the drug labeling so that physicians prescribing the drugs can balance the risks of side effects against the beneficial effects of the drug. Many side effects of drugs are unavoidable.

AndroGel has no proven benefit and has a huge risk of heart attack. Further, Abbott Laboratories and AbbVie, Inc, the manufacturer did not give any warnings of the risk of heart attack to physicians. This is the classic definition of a dangerous and defective drug that can be the basis for a lawsuit by those men who have had heart attacks or strokes after beginning to take AndroGel for “low T”

The massive television advertising campaign to sell AndroGel has resulted in thousands of heart attacks according to the recent medical studies.

Our law firm is representing men who have had a heart attack while taking AndroGel for low testosterone.

Update on Low T – May 5th, 2014 

CBS Chicago recently released a report called “2 Investigators: Low-T Drugs Could Have Dangerous Side Effects.” The article reports that dozens of lawsuits have been filed claiming that the warnings are not sufficient to advise consumers of the possible risks related to taking Low T medications.

Dr. Carl Pallais, an endocrinologist and assistant professor of medicine at Harvard Medical School stated that despite the heavy influx of marketing ads touting the benefits of Low T medications, men should be aware of the potential long-term hazards.

Prior Low T Studies

A November 6, 2013, the New England Journal of Medicine published a study of 8.700 veterans who had undergone coronary angiograms. A cardiologist with the New England Journal of Medicine, Harlan Krumholz, warned against the onslaught of ads promoting testosterone treatment. He stated that the study provides cautionary information, as well as reminds us of the dangers of chasing surrogate outcomes, like testosterone levels, may actually cause harm. We need outcomes studies to understand better the safety of these products.”

January 29, 2014, PLOS One published a research article that indicated that men over 65 had an increased chance of suffering a heart attack within three months from the initial prescription. The study concluded that the risk of myocardial infarction increased in older men and younger men with pre-existing heart disease.
FDA Investigation

Based on these two studies, the FDA began an investigation in January. The FDA released a Safety Statement on January 31, 2014, announcing that they are investigating the claims of risk of stroke, heart attack and death related to FDA approved testosterone products. While the statement claims that the FDA has not concluded that the patients should stop taking approved testosterone products, it also states that the testosterone products approved by the FDA are only for use in men with an associated medical condition. In other words they must have been tested for and have proven Low T results. To date, the FDA has not yet concluded its investigation.

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Saunders & Walker
3491 Gandy Blvd
Pinellas Park, FL 33781
Phone: (727) 579-4500
Phone: 1-800-748-7115

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