PHILADELPHIA, June 9 /PRNewswire-FirstCall/ -- Shire Limited (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced today a voluntary recall of two (2) lots of the ADHD patch DAYTRANA (lots 2750211 and 2764111). Shire is taking this action because some DAYTRANA patches do not meet their release liner removal specification, and as a result, patients and caregivers could have difficulties removing the liners. This voluntary recall is not due to safety issues.
Because this voluntary recall is not due to product safety issues, all DAYTRANA patches, including those in the lots listed above, 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. Noven Pharmaceuticals, Inc. continues to manufacture and Shire continues to promote this product in the United States.
Shire will continue its ongoing quality assurance monitoring and data analysis of DAYTRANA, and may implement future additional voluntary actions. Shire and Noven continue to actively pursue enhancements to this product, and to work closely with the United States Food and Drug Administration (FDA) to implement changes that may enhance the usability of DAYTRANA.
Physicians, patients and caregivers who have questions regarding DAYTRANA should call Shire's DAYTRANA customer service line at 1-800-828-2088, option 1, and pharmacists should call 1-888-879-8218.
DAYTRANA is licensed globally to Shire by Noven. Shire and Noven have notified the FDA of this voluntary recall.
Notes to editors
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.
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.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: http://www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF(beta)3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.
|SOURCE Shire Limited|
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