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FDA adds abuse warning to Xanax, Valium labels

 


Thursday, September 24, 2020 (Health Day News)-In response to increasing abuse of benzodiazepine sedatives such as barium, Xanax, and Ativan, U.S. officials added a “boxed warning” to drug labels on Wednesday, dangerous I warned about sex.

Benzodiazepines are tranquilizers commonly prescribed to relieve problems such as anxiety, seizures, insomnia, and panic disorder.

However, “Benzodiazepines are an important treatment for many Americans, but they are often abused or misused with opioid analgesics and other medications, alcohol and illicit drugs,” said a member of the US Food and Drug Administration. , Dr. Stephen Hahn said in the agency’s news release.

As a result, the FDA is now taking steps to help healthcare professionals and patients better understand that while benzodiazepines have many therapeutic benefits, they increase the risk of abuse, misuse, addiction, and addiction. , Requesting new label information. “

The illegal use of “benzo” is increasing, and the drug is often taken with opioid drugs.

In fact, a report released last year by the US Centers for Disease Control and Prevention found that benzo was involved in one-third of all deadly opioid overdose. The drug was also involved in nearly two-thirds of the fatal synthetic opioid fentanyl-related overdose. The report reviewed data from 2017 to 2018 in 25 states.

According to the FDA, in 2019 alone, more than 92 million prescriptions were directed to benzodiazepines, with the most commonly used drugs in this class being alprazolam / xanax (38%), followed by clonazepam / chronopin (24%). ), And lorazepam. / Ativan (20%).

“Benzodiazepines are very helpful in the short-term treatment of recommended illnesses,” said Dr. Teresamare Amato, chair of emergency medicine on the Jewish Forest Hill in Long Island, New York City.

However, the important phrase is “short term”. Generally, benzo is recommended for less than a month. “About 50% of benzodiazepine prescriptions were taken for more than two months,” Amato said, according to recent FDA data.

So, “providers need to consider the risks and benefits of prescribing longer courses of these drugs,” she said. “The FDA hopes that by adding wording to the current warning, providers will pay attention not only to the prescribing of these drugs, but also to the duration,” Amato said.

The FDA pointed out that benzodiazepine addiction does not take long to prolong.

“Steady use of benzodiazepines for days or weeks can lead to physical dependence, and patients who have been taking benzodiazepines for weeks or months have abruptly discontinued the drug. Sometimes it can show signs and symptoms of withdrawal. “

The agency emphasized that doctors’ guidance is needed to separate oneself from tranquilizers.

“A sudden stoppage of benzodiazepines or a premature dose reduction can cause acute withdrawal reactions, including seizures, which can be life-threatening,” the FDA said.

Amato agreed.

“If you are currently taking benzodiazepines and have concerns, talk to your doctor,” she said. “If you have been with them for a long time before talking to your healthcare provider, do not stop taking them. For patients taking these medications, safely taper their dosage. Therefore, we need close medical supervision. “

In addition to adding new boxed warnings, the medication guide that accompanies the drug will be revised to better inform patients of the risk of abuse, the agency said.

For more information

The US National Laboratory for Drug Abuse Benzodiazepine..

Source: Teresa Murray Amato, MD, Chair, Emergency Medicine, Long Island Jewish Forest Hill, New York City; US Food and Drug Administration, News Release, September 23, 2020

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