F.D.A. Requires Stronger Warning Label for Xanax and Comparable Medicine

F.D.A. Requires Stronger Warning Label for Xanax and Similar Drugs

The Food and Drug Administration announced on Wednesday that a new warning label for a class of common psychotropic drugs called benzodiazepines will be required to better warn the public and health professionals about the serious risks of abuse and addiction.

Benzodiazepines are prescribed for anxiety, insomnia, seizures, panic disorders, and other health problems. They are also often given before certain medical procedures. They slow down brain activity and cause calming or calming effects.

The drugs are hugely popular. In 2019, according to the agency, around 92 million prescriptions for benzodiazepines – such as the highly prescribed Xanax, Klonopin and Ativan – were issued in the USA.

In a press release, Dr. Stephen Hahn, the F.D.A. The Commissioner said he was concerned about the widespread abuse of the drugs, particularly when taken with opioid pain relievers, alcohol or other drugs. The National Institute on Drug Abuse reports that more than 30 percent of opioid overdoses also involve benzodiazepines.

"We are taking action and need new labeling information to help healthcare professionals and patients better understand that while benzodiazepines have many treatment benefits, they also have an increased risk of abuse, abuse, addiction and dependence," said Dr. Rooster.

The current drug labeling information "does not provide adequate warnings about the serious risks and harms associated with these drugs," says the F.D.A.'s announcement.

The agency also warned that within days, people could become physically addicted to the drugs and have difficulty stopping them safely. The agency said the resignation could take months It urged doctors to be more careful when prescribing benzodiazepines with opioids or other drugs that suppress the central nervous system. Such combinations can cause serious side effects, difficulty breathing, or death.

The F.D.A. The measures followed a review of the reported serious side effects – known as "adverse events" – and scientific studies of the drugs. The agency did not disclose how many adverse events were reported in its database.


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