Benzodiazepines are class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder. The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately. This increases these serious risks, especially when benzodiazepines are used with some other medicines and substances.
To address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions, the U.S. Food and Drug Administration (FDA) is requiring the Boxed Warning be updated for all benzodiazepine medicines.
As per FDA “Benzodiazepines even when taken at recommended dosages, their use can lead to misuse, abuse, and addiction. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs. Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening”.
FDA stated “postmarking cases data review found that benzodiazepines are widely prescribed in the U.S., often for long periods of time. They are also widely abused and misused, often together with alcohol, prescription opioids, and illicit drugs, which worsen the risks of serious problems. We also found that some patients have had serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose was reduced too quickly. Some patients experienced withdrawal symptoms lasting many months.
In addition to requiring an update to the Boxed Warning, the FDA is requiring other changes to the Warnings and Precautions, Drug Abuse and Dependence and Patient Counseling Information sections of the prescribing information for all benzodiazepine products. The agency is also requiring revisions to the existing patient Medication Guides for these medicines to help educate patients and caregivers about these risks.
Reference:
Leave a Reply