The U.S. Food and Drug Administration (FDA) has ordered that makers of testosterone products must update their products’ labels in order to clarify their products’ approved indications and to advise on a potential risk of heart attack and stroke, according to Bloomberg.
Background to the FDA Decision
Studies conducted by the University of Texas Southwestern Medical Center at Dallas and the National Institute of Aging both found that elderly men treated with testosterone replacement products were at an increased risk of suffering hypertension, heart attack, stroke, and death.
Another study, published in PLoS One in 2014, found that men over the age of 65 and men with undiagnosed heart disease experienced a two-fold increased risk of heart attack after the first 90 days of testosterone therapy.
That same year, the FDA announced that it would be investigating the efficacy and safety of testosterone therapy.
Among the products investigated by the FDA were:
- Axiron (Eli Lilly)
- Androderm Patch (Actavis PLC)
- Androgel (AbbVie)
About the Testosterone Label Update
According to the FDA, all testosterone products must carry a warning addressing an increased risk of heart attack and stroke.
Additionally, labels must now state that that testosterone replacement therapy has only been approved to treat low testosterone levels (low-T) caused by hypogonadism. Hypogonadism is the result of disorders of the testicles, pituitary gland, or brain.
In their decision, the FDA reiterated that testosterone is not indicated for the relief of low-T symptoms that are related to aging, despite a growing market for such treatment.
The FDA is also requiring manufacturers of testosterone products to conduct clinical trials analyzing the risk of heart attack and stroke associated with their individual drugs.
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About the HeartWare VAD Controller Recall
The recall is for controllers that were distributed before the VAD's 2012 FDA approval as a bridge therapy for patients awaiting heart transplantation.
The recall states that an issue with the constrollers can cause an electrostatic discharge, which leads to malfunction and can cause the VAD to stop working.
Previously, in 2013, HeartWare issued a Field Safety Correction Action because of electrostatic concerns. The issue was linked to serious injuries and at least one death.
HeartWare was cited by the FDA in 2014 for failing to take appropriate measures to respond to 27 complaints of controller failure that were received over a three-year period.
Models Affected by the Recall
The products affected by the recall have codes 1400 and 1401XX, which were distributed during the company’s ADVANCE and ENDURANCE clinical trials.
The recall affects approximately 120 U.S patients.
Class 1 recalls are reserved for product defects that may result in serious injury and death.
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About the Helmet/Concussion Research
In-helmet add-ons have become popular because many have feared the long-term effects of brain injuries. According to experts, few add-ons have gone through rudimentary biomechanical evaluation. Because of this, Dr Lloyd, a research director of BRAINS Inc, and his team are doing an impact testing of protective headgear to measure the linear and angular kinematics.
They tested four football helmet add-ons:
- Guardian Cap (a soft shell layer that fits over the helmet)
- UnEqual Technologies' Concussion Reduction Technology (CRT) (inserts made of a strong thin and flexible composite material)
- Shockstrips (strips of adhesive foam-like material attached to the outside of the helmet)
- Helmet Glide (fluid applied to the outside of the helmet designed to disperse kinetic energy and reduce surface tension)
Method and Findings of the Helmet Study
Researchers put the Riddell Revolution Speed and a Xenith X1 helmets on each of the add-ons and tested them five times from three different heights (1 m, 1.5 m, and 2 m) while using a crash test dummy.
The purpose of the test was to measure the bounce, linear, and angular motion. The result showed that for Guardian Cap, CRT, and Shockstrips the linear acceleration decreased 11% compared with a standard helmet that had no add-ons.
Researchers believe that helmet designer should be measuring angular acceleration, not just linear acceleration when testing helmets. If this happen, helmets will be safer in the future.
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