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U.S. Department of Health and Human Services

Safety

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Daytrana (methylphenidate) transdermal system

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

 

June 2013 

Summary View

 

*Raynaud’s phenomenon
 

WARNINGS and PRECAUTIONS

Peripheral Vasculopathy, including Raynaud’s phenomenon
  • Stimulants, including Daytrana, 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 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
 

PATIENT COUNSELING INFORMATION

Information for Patients
  • Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]
  • Instruct patients beginning treatment with Daytrana 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 Daytrana
  • 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 Daytrana?
  • 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 your 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 Daytrana 

 

December 2009 

Summary View

 

WARNINGS 

Contact Sensitization
  • In an open-label study of 305 subjects conducted to characterize dermal reactions in children with ADHD treated with Daytrana using a 9-hour wear time, one subject (0.3%) was confirmed by patch testing to be sensitized to methylphenidate (allergic contact dermatitis). This subject experienced erythema and edema at Daytrana application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate.

ADVERSE REACTIONS

Skin Irritation
  • In an open-label study of 305 subjects conducted to characterize dermal reactions in children with ADHD treated with Daytrana using a 9-hour wear time, one subject (0.3%) was confirmed by patch testing to be sensitized to methylphenidate (allergic contact dermatitis). This subject experienced erythema and edema at Daytrana application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. The subject was not transitioned to oral methylphenidate. Confirmation of a diagnosis of allergic contact dermatitis may require further diagnostic testing.

MEDICATION GUIDE

What are possible side effects of Daytrana?
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.