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U.S. Department of Health and Human Services

Safety

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Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Extended-Release Tablets), and Ritalin LA (Extended-Release Capsules)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

*Raynaud’s phenomenon
 

WARNINGS

Peripheral Vasculopathy, including Raynaud’s phenomenon
  • Stimulants, including Ritalin and Ritalin SR, 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 post-marketing 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 increase 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 Ritalin or Ritalin SR about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and in 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 Ritalin or Ritalin SR
  • Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients
 

MEDICATION GUIDE

What is the most important information I should know about Ritalin?
  • 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
  • Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
  • Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Ritalin.