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Because this voluntary recall is not due to product safety issues, allDAYTRANA patches, including those in the lots listed above, can continue to beused unless the release liner cannot be removed, or the patches are damagedwhile being opened.
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The current supply levels of DAYTRANA should be sufficient to ensure thatpatients can continue to have their DAYTRANA prescriptions filled at theirlocal pharmacy. Noven Pharmaceuticals, Inc. continues to manufacture and Shirecontinues to promote this product in the United States.
Shire will continue its ongoing quality assurance monitoring and dataanalysis of DAYTRANA, and may implement future additional voluntary actions.Shire and Noven continue to actively pursue enhancements to this product, andto work closely with the United States Food and Drug Administration (FDA) toimplement changes that may enhance the usability of DAYTRANA.
Physicians, patients and caregivers who have questions regarding DAYTRANAshould call Shire's DAYTRANA customer service line at 1-800-828-2088, option1, and pharmacists should call 1-888-879-8218.
DAYTRANA is licensed globally to Shire by Noven. Shire and Noven havenotified the FDA of this voluntary recall.
Notes to editors
Important Safety Information
Tell your doctor about any heart conditions, including structuralabnormalities, your child or a family member may have. Inform your doctorimmediately if the child develops symptoms that suggest heart problems, suchas chest pain or fainting.
Daytrana should not be used if the child has: significant anxiety,tension, or agitation; allergies to methylphenidate or other ingredients ofDaytrana; glaucoma; discontinued in the last 14 days or is taking a monoamineoxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette'ssyndrome.
Tell your doctor before using Daytrana if the child: is being treated foror has symptoms of depression (e.g. sadness, worthlessness, or hopelessness)or bipolar disorder; has family history of tics; has abnormal thoughts orvisions, hears abnormal sounds, or has been diagnosed with psychosis; has hadseizures or abnormal EEGs; has or has had high blood pressure; exhibitsaggressive behavior or hostility. Tell your doctor immediately if the childdevelops any of these conditions/symptoms while using Daytrana.
In clinical studies, side effects were generally mild to moderate. Themost common side effects reported with Daytrana were decreased appetite,sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics,and affect lability (mood swings). Aggression, new abnormalthoughts/behaviors, mania, and growth suppression have been associated withuse of drugs of this type. Tell your doctor if the child has blurred visionwhile using Daytrana.
Abuse of Daytrana can lead to dependence.
Daytrana should be applied daily to clean, dry skin, which is free of anycuts or irritation. Skin redness or itching is common with Daytrana. Allergicskin rash may occur.
SHIRE LIMITED
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit and hyperactivitydisorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) andrenal diseases. The structure is sufficiently flexible to allow Shire totarget new therapeu
