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U.S. Department of Health and Human Services

Safety

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Metadate CD (methylphenidate HCl) Extended-Release Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

June 2013 

Summary View

 

WARNINGS

Peripheral Vasculopathy, including Raynaud’s phenomenon
  • Stimulants, including Metadate CD, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
 
PRECAUTIONS
Information for Patients
  • Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] Instruct patients beginning treatment with Metadate CD about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red
  • Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
  • Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Metadate CD
  • Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
 

MEDICATION GUIDE

Call your doctor right away if you or your child have any new or worsening...
  • Circulation Problems in fingers and toes (Peripheral vasculopathy, including Raynaud’s phenomenon): fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red… 

 

May 2013

Summary View

PRECAUTIONS

Information for Patients
  • Patients should be advised to avoid alcohol while taking METADATE CD. Consumption of alcohol while taking METADATE CD may result in a more rapid release of the dose ofmethylphenidate

ADVERSE REACTIONS

Postmarketing Experience
  • added ......bruxism

MEDICATION GUIDE

  • METADATE CD should not be taken with alcohol. This may result in a more rapid release of the dose of METADATE CD.