New Dysport Indication Approved
August 1, 2016 – The FDA approved Dysport® (abobotulinumtoxinA) for a new indication. Dysport, manufactured by Ipsen Biopharmaceuticals, was already approved for several adult conditions, including cervical dystonia and upper limb spasticity. It now also can be used to treat lower limb spasticity (inflexibility, spasms or stiffness in the leg muscles) for children as young as two years old. Lower limb spasticity is fairly common for children who have cerebral palsy, head injuries, multiple sclerosis (MS), spinal cord injuries or stroke.
Recommended pediatric dosing depends on the weight of the patient, the number of affected muscles and the severity of spasticity and is generally 10 to 15 units per Kg of body weight. Dosing should not exceed 15 units/Kg per leg or 1000 units total per treatment. Injections should be given at intervals of at least 12 weeks. All botulinum toxin products, including Dysport, carry a boxed warning that they may migrate away from the areas where they are injected and possibly cause widespread side effects, such as serious breathing or swallowing problems.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.