Qudexy XR Indicated to Prevent Migraine Headaches
March 30, 2017 – The U.S. FDA approved Qudexy® XR (topiramate) extended-release capsules, to prevent migraine headaches for patients at least 12 years old. Manufactured by Upsher-Smith Laboratories, Qudexy XR was previously approved to manage some types of seizures. It is to be taken once daily at bedtime to block migraines and the starting dose is 25mg, which is increased over four weeks or longer to a maintenance dose of 100mg per day. Medication Guides for Qudexy XR and other drugs like it, warn that the drugs may cause fever, mood changes and vision problems. Patients taking Qudexy XR for any reason should not stop it suddenly.
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 U.S. mail or by fax.
- 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
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.