"The US Food and Drug Administration (FDA) has approved an expanded indication for onabotulinum toxin A (Botox, Actavis) for the treatment of adults with upper limb spasticity, according to a company news release.
The expanded i"...
- Inform patients of the signs and symptoms of thrombosis, such as such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain. Advise patients to seek immediate medical attention if any of these symptoms occur.
- Inform patients of the signs and symptoms of hypersensitivity reactions, such as urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. Advise patients to discontinue use of the product if these symptoms occur and seek immediate emergency treatment.
- Inform patients that because FEIBA is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- Advise patients to report any adverse reactions or problems following FEIBA administration to their physician or healthcare provider.
To enroll in the confidential, Industry-wide Patient Notification System, call 1-888-873-2838.
Last reviewed on RxList: 3/7/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Feiba VH Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.