When the FDA made the decision to give Johnson & Johnson’s diabetes drug Invokana a black box warning in 2017, one would like to believe that the decision was not made lightly. The boxed warning is the strongest warning the agency can issue for a drug on the US healthcare market and indicates that the product can pose grave risks to the consumer if used. There is ...
Xeljanz Gets Black Box Warning
Posted August 19, 2019 in Drug and Medical Device Lawsuits | Product News and Recalls
Citing data gathered from an ongoing clinical trial, the United States Food and Drug Administration has issued a black box warning for Pfizer’s rheumatoid arthritis and ulcerative colitis medication Xeljanz. The warning, the agency’s most severe, also applies to the extended release version of the drug, Xeljanz XR.
The warnings stem from the discovery of an increased risk of blood clots and the death of ...
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The sale and implantation of Essure in the United States is facing a new set of federally-mandated restrictions, and the government has left the enforcement of that mandate to the company that manufactures the device being restricted.
In response to a decline in demand for its female sterilization solution that quite literally spans the globe, Bayer ceased sales of Essure in every market on the planet except the United States ...
continue reading...FDA Warns That Some Antibiotics May Cause Severe Nerve Damage
Posted February 5, 2015 in Product News and Recalls
An antibiotic class known as fluoroquinolones has been linked to serious nerve damage when taken orally or by injection. The condition is known as peripheral neuropathy. It can be severe, comes on suddenly, and may be permanent. A story posted on WebMD details how the U.S. Food and Drug Administration (FDA) elevated the warnings regarding these drugs and their potential adverse effects.
Fluoroquinolones are commonly used antibiotics. They are frequently used for the treatment of respiratory ...
continue reading...Surgical “Black Box” in Development to Prevent Medical Errors
Posted October 27, 2014 in Drug and Medical Device Lawsuits | Medical Malpractice | Product News and Recalls
A Toronto hospital is working on developing a device that seeks to protect patients in the operating room. The system, detailed in a recent article in Forbes, would be installed in operating rooms in order to cut down on surgical errors. It would consist of a number of microphones and cameras that are poised to track and record the movements and communications within the room.
The “black box” could be used to analyze ...
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