Austedo Approved for Tardive Dyskinesia
August 30, 2017 – The U.S. FDA has approved Austedo® (deutetrabenazine), manufactured by Teva Pharmaceuticals, to treat tardive dyskinesia. The drug is believed to temporarily decrease the amounts of monoamines—including dopamine and serotonin—within the brain; this may help to modulate signals between nerves in the body.
Tardive dyskinesia is a side effect that results from the long-term use of certain drugs, including antipsychotic medications. It is characterized by uncontrollable movements, primarily of the face, though it can also affect other parts of the body. Austedo was originally approved earlier this year to treat adult patients with chorea, a condition similar to tardive dyskinesia and caused by Huntington’s disease.
Recommended dosing of Austedo for treatment of tardive dyskinesia is 12mg per day to start, with increases made at weekly intervals if necessary, up to a maximum of 48mg per day. Austedo carries a black box warning cautioning that patients may experience an increase in symptoms of depression and thoughts of suicide.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.