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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Non-safety-related voluntary market withdrawal of a limited portion of DAYTRANA® (methylphenidate transdermal system) patches announced

 

Contact:
Matthew Cabrey, Shire, Corporate Communications
484 595 8248
 

 

FOR IMMEDIATE RELEASE -- March 20, 2009– Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today a voluntary market withdrawal/recall of thirty-nine (39) lots of the ADHD patch DAYTRANA (the lots of DAYTRANA patches affected by this action are listed below). Shire is taking this action because some DAYTRANA patches no longer meet their release liner removal specification, and as a result, patients and caregivers could have difficulties removing the liners.

This action is not due to safety issues. All DAYTRANA patches, including those in the lots listed below, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened.

The current supply levels of DAYTRANA should be sufficient to ensure that patients can continue to have their DAYTRANA prescriptions filled at their local pharmacy. Physicians, patients, and caregivers who have questions about DAYTRANA should call Shire’s DAYTRANA customer service line at 1-800-828-2088, option 1, and pharmacists should call 1-888-202-3822.

Noven Pharmaceuticals, Inc. continues to manufacture and Shire continues to promote DAYTRANA in the United States. DAYTRANA is licensed globally to Shire by Noven. Shire and Noven have notified the United States Food and Drug Administration (FDA) of this voluntary action.

Shire and Noven are committed to continuing ongoing quality assurance monitoring and data analysis of DAYTRANA, and may implement additional voluntary actions. Shire and Noven continue to actively pursue enhancements to DAYTRANA, and are working with the FDA to implement changes intended to enhance the usability of DAYTRANA.

For further information please contact: Media Matthew Cabrey, Shire, Corporate Communications +1 484 595 8248

DAYTRANA lots affected by this action are: 2616311*, 2617211*, 2733211*
2570611, 2617011, 2617111, 2656911, 2657211, 2657212,
3014511, 3073511, 2572011, 2732811+, 27328111, 2617811, 2624711, 2625211, 3051911,
31947, 31949, 31951, 33041, 33042, 34172, 2572411, 2572611, 2573211, 2573311,
2573411, 2652411, 2733111, 2737411, 2750111, 3015011, 3015311, 31739,
31920, 31921, 31922, 31923.

*These Lots are subject to a voluntary recall.
+Cartons from Lot 2732811 were re-packaged as Lot 27328111.

Important Safety Information

Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.

Daytrana should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette’s syndrome. Tell your doctor before using Daytrana if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana.

In clinical studies, side effects were generally mild to moderate. The most 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 abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using Daytrana.

Abuse of Daytrana can lead to dependence.

Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Daytrana. Your healthcare provider may stop Daytrana treatment if a problem is found during these check-ups. Daytrana should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin redness or itching is common with Daytrana. Allergic skin rash may occur.

About ADHD

ADHD is one of the most common psychiatric disorders in children and adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with large variability), according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US adults aged 18-44 (~ 9.8 million) based on results from the National Comorbidity Survey Replication.

ADHD is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific aetiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate diagnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual™-IV (DSM-IV) or International Classification of Diseases 10 (ICD-10). Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological, or behavioral modification, and medication.

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