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AndroGel Pulmonary Embolism Lawsuit

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AndroGel has clear benefits for men with missing testicles or hypogonadism, but the risk of pulmonary embolism (blood clot in the lungs) may outweigh these benefits for millions of men without severe hormonal disorders. AbbVie is accused of aggressively marketing AndroGel for “Low T” while downplaying evidence linking AndroGel and pulmonary embolism.

Overview

Over two-thirds of men on testosterone treatment use AndroGel (testosterone gel), a topical product that comes in 1% and 1.62% concentrations. It is marketed by AbbVie for symptoms of low testosterone, or “Low T,” which include common aspects of aging — lower energy, sagging muscles, flagging libido, depression, and more. The popularity of AndroGel increased five-fold from 2000 to 2011.

What is the problem?

Although AndroGel is used by over 5 million men, only 50% actually have hypogonadism, and up to 25% never had a blood test. This is concerning, because there are no long-term safety studies of testosterone therapy. Estrogen therapy, which was promoted for women in the 1990s, has since been shown to increase cardiovascular and breast cancer risks. Recently, numerous studies have suggested similar cardiovascular risks, including pulmonary embolism, from AndroGel.

Studies of AndroGel Pulmonary Embolism Risks

Pulmonary embolisms occur when blood clots get trapped in the lungs. AndroGel increases the risk of blood clots by thickening the blood, increasing the number of red blood cells, and elevating blood pressure. Numerous studies linking AndroGel and cardiovascular side effects have been published, including:

  • Translational Research, 2011: Dr. Charles Glueck and colleagues described several case reports of pulmonary embolism in men on testosterone therapy. Most cases occurred in men with genetic risk-factors for blood clots, which are estimated to affect 5% of the general population.
  • Journal of the American Medical Association, 2013: Testosterone therapy linked to 30% increased risk of cardiovascular side effects.
  • PLoS One, 2014: Testosterone therapy doubles the risk of heart attack for men over 65, and triples the risk for men under 65 who have heart disease.

What is a Pulmonary Embolism?

Pulmonary embolisms usually occur as a complication of Deep Vein Thrombosis (DVT), in which blood clots form in the lower leg, thigh, or pelvis. If these blood clots break loose, they may travel in the bloodstream and get pumped through the heart and into the lungs. Once inside the lungs, clots obstruct blood vessels and reduce the amount of oxygen in the body. If untreated, about 30% of pulmonary embolisms are fatal.

Symptoms of Pulmonary Embolism

  • Blood clots
  • Chest pain
  • Sharp pain that gets worse when breathing
  • Coughing up blood
  • Cyanosis (blue discoloration of skin, lips, nails)
  • Irregular or very fast heartbeat
  • Leg swelling, warmth, discoloration, or pain
  • Low blood pressure
  • Dizziness or loss of consciousness

 

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