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The U.S. Food and Drug Administration is requiring a stronger warning label on a group of drugs commonly used by many Americans for anxiety, the agency announced Wednesday.
All benzodiazepine products, which include well-known drugs such as Xanax and Valium, must have warning labels that spell out the risks of abuse, misuse, addiction, physical dependence and withdrawal. The FDA has called for a “Boxed Warning,” which is the agency’s most prominent safety warning.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs,” said FDA Commissioner Dr. Stephen Hahn.
In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. pharmacies with alprazolam – commonly known by its brand name Xanax – making up 38% of those prescriptions, according to the FDA.
The agency says benzodiazepines are used for anxiety disorder, insomnia, seizures, social phobia and panic disorders. However, physical dependence can occur when they’re taken steadily for several days and weeks.
Dr. Teresa Murray Amato, chair of emergency medicine at Long Island Jewish Forest Hills in Queens, New York City, said approximately 50% of those prescriptions last year were for more than two months, despite recommendations for only short courses.
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"Although benzodiazepines are very helpful for short term treatment, providers need to consider the risks and benefits of prescribing longer courses of these medications," she said.
Stopping these drugs abruptly or reducing the dosage too quickly after a long period of time can result in withdrawal reactions such as seizures, which the FDA says can be life-threatening. Patients should speak with their health care provider to develop a plan for slowly tapering medication before stopping, the agency said.
In addition to the warning label, the FDA is also requiring changes to prescribing information on all products and existing patient Medication Guides.
"The FDA is hoping that by adding verbiage to the current warning that providers will be extra careful in not only prescribing these medications, but also to be mindful of the duration," Amato said.
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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September 25, 2020 at 12:00AM
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FDA requires stronger warning label for Xanax, Valium and other similar benzodiazepine drugs - USA TODAY
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