The US Food and Drug Administration (FDA) announces that it is requiring the Boxed Warning be updated for all benzodiazepine medicines to address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions. Benzodiazepines are widely used to treat many conditions, including anxiety, insomnia, and seizures. 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.
Benzodiazepines can be an important treatment option for treating disorders for which these drugs are indicated. However, 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 is requiring the Boxed Warning, FDA’s most prominent warning, be updated and adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks. Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.
The list of benzodiazepines include: alprazolam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, oxazepam, quazepam, temazepam and triazolam.
Health care professionals should:
- When deciding whether the benefits of prescribing a benzodiazepine outweigh the risks, health care professionals should consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction. Particular caution should be taken when prescribing benzodiazepines with opioids and other medicines that depress the central nervous system (CNS), which has resulted in serious side effects, including severe respiratory depression and death. Advise patients to seek immediate medical attention if they experience symptoms, such as difficulty breathing.
- Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines. Throughout therapy, monitor the patient for signs and symptoms of abuse, misuse, or addiction. If a substance use disorder is suspected, evaluate the patient and institute, or refer them for, early substance abuse treatment, as appropriate.
- To reduce the risk of acute withdrawal reactions, use a gradual taper to reduce the dosage or to discontinue benzodiazepines. No standard benzodiazepine tapering schedule is suitable for all patients; therefore, create a patient-specific plan to gradually reduce the dosage, and ensure ongoing monitoring and support as needed to avoid serious withdrawal symptoms or worsening of the patient’s medical condition.
- Take precautions when benzodiazepines are used in combination with opioid addiction medications. Careful medication management by health care professionals can reduce the increased risk of serious side effects.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class
In Hong Kong, there are registered pharmaceutical products containing alprazolam (17 products), chlordiazepoxide (5 products), clobazam (1 product), clonazepam (10 products), diazepam (31 products), lorazepam (9 products) and triazolam (1 product). All products are prescription-only medicines. There is no registered pharmaceutical product containing clorazepate, estazolam, flurazepam, oxazepam, quazepam, temazepam.
So far, the Department of Health (DH) has received adverse drug reaction related to clonazepam (3 cases), diazepam (3 cases, of which one case is related to drug abuse) and lorazepam (2 cases, of which one case is related to drug dependence). The DH has not received any case of adverse drug reaction related to alprazolam, chlordiazepoxide, clobazam and triazolam.
The risk of abuse, tolerance, dependence and withdrawal symptoms associated with the use of benzodiazepines are documented in overseas reputable drug references such as the “AHFS Drug Information”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Sep 24, 2020
Issued at HKT 18:00
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