Chewable Methylphenidate Approved
December 14, 2015 – The U.S. Food and Drug Administration (FDA) approved QuilliChew ER (methylphenidate extended release) tablets CII for the treatment of attention deficit hyperactivity disorder (ADHD) for children who are at least six years of age. QuilliChew ER, manufactured by Pfizer, is recommended to be started at 20mg once daily, and can be increased by up to 10mg per week until 60mg daily. Doses above 60mg daily are not recommended. It is recommended that QuilliChew ER be taken in the morning. Upon release in early 2016, QuilliChew ER will be available in 20mg, 30mg, and 40mg tablets, with the 20mg and 30mg scored for ease in splitting and dose adjustment. QuilliChew ER has a different basic structure and different release properties than other marketed methylphenidates and so caregivers must avoid trying to match the strength of previous medications. People on QuilliChew ER are at risk for abuse and dependence due to its methylphenidate content which is a central nervous system stimulant.
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 a 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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.