(RxWiki News) The US Food and Drug Administration (FDA) is ordering a stronger warning for a common anxiety and sleep medication.
The FDA is requiring that the boxed warning, the strongest type of medication warning, be updated for all benzodiazepine medicines. The risks tied to these drugs must also be detailed in the medication guide that is given to patients who are prescribed benzodiazepines, the FDA noted.
“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence,” said FDA Commissioner Dr. Stephen M. Hahn in a press release.
Benzodiazepines are used to treat anxiety, seizures and sleep issues.
The FDA said it was concerned that the current prescribing information did not adequately list or reflect the serious risks and harms associated with these medicines.
The updated benzodiazepine warnings will include the risks of abuse, misuse and addiction in an effort to help improve their safe use.
Other potential risks include physical dependence and withdrawal reactions.
Even at the recommended dose, these medications can result in misuse, abuse and addiction, which can lead to overdose or death. These risks increase if benzodiazepines are taken with other substances, such as pain killers, alcohol and street drugs.
When benzodiazepines are taken for several days to weeks, they may lead to physical dependence. And if the medication is stopped or the dose is reduced suddenly or too quickly, the user can experience withdrawal signs and symptoms. In some cases, some people may experience seizures, which can be life-threatening.
An estimated 92 million benzodiazepine prescriptions were dispensed from US outpatient pharmacies in 2019.
Some medications found in the benzodiazepine class include the following:
- Alprazolam (Xanax, Xanax XR)
- Clonazepam (Klonopin)
- Lorazepam (Ativan)
- Diazepam (Diastat, Diastat Acudial, Valium, Valtoco)
- Temazepam (Restoril)
Here is what you need to know about benzodiazepines:
- Always tell your health care professionals about all the medications you are taking. These include prescription drugs, over-the-counter (OTC) medications, herbal and dietary supplements and alcohol.
- Take all medicines exactly as prescribed by your health care professional.
- Never suddenly stop taking benzodiazepines or reduce the dose too quickly. Always talk to your doctor if you wish to stop taking your medication. Your doctor will give you a plan for slowly lowering the dose and frequency.
- Contact your health care provider if you experience any withdrawal symptoms.
- Go to an emergency room or call 911 if you have trouble breathing or other serious side effects, such as seizures.
If you are taking one of these medications, speak with your doctor if you have any questions or concerns.