ADDERALL® (mixed salts of a single-entity amphetamine product) Supply Clarification

PHILADELPHIA, Dec. 1, 2011 /PRNewswire/ -- Shire plc, the global specialty biopharmaceutical company, responds to questions about reports of a supply shortage of ADDERALL® (mixed salts of a single-entity amphetamine product) Tablets, CII.  ADDERALL® is an immediate release formulation and is sometimes referred to as "ADDERALL IR."  While Shire is aware of the reports of the supply shortage, Shire cannot provide additional information because Shire does not own, manufacture or distribute the medication.  Shire suggests that questions about the supply shortage be directed to the companies that manufacture and/or distribute ADDERALL IR.

Shire developed ADDERALL IR, and the FDA approved ADDERALL IR as a treatment for ADHD in children in 1996.  Shire divested ADDERALL IR in 2007 and no longer owns, manufactures, or distributes ADDERALL IR or any of its generic forms.  Several pharmaceutical companies currently manufacture and distribute generic forms of ADDERALL IR.  According to the FDA, those companies are Sandoz, CorePharma, and Teva. Additional information about the supply shortage of ADDERALL IR is posted on the FDA Drug Shortages website: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Shire also developed and currently manufactures ADDERALL XR® (mixed salts of a single-entity amphetamine product) Capsules, CII, an extended release capsule formulation that was first approved by FDA in 2001 as a treatment for ADHD in children.  ADDERALL XR® is available at pharmacies and current inventories of all strengths of ADDERALL XR® are sufficient to meet patient demand. 

ADDERALL XR is a stimulant medication and federally controlled substance (CII) because it can be abused or lead to dependence.  Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

INDICATION 

ADDERALL XR is a prescription medicine for the treatment of ADHD in children ages 6 to 17 and adults. ADDERALL XR should be used as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

• ADDERALL XR should not be taken by patients who have:
  Heart disease or hardening of the arteries,  moderate to severe high blood pressure,  overactive thyroid gland (hyperthyroidism),  glaucoma, agitated states, a history of drug abuse, taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the last 14 days, or sensitivity to, are allergic to, or had a reaction to other stimulant medicines. 

• ADDERALL XR is a stimulant medicine. The following have been reported with use of stimulant medicines.

          Heart-related problems:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate
  Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.  Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking ADDERALL XR.

          Mental (Psychiatric) problems:
          All Patients

• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressive behavior or hostility

          Children and Teenagers

• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
  Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.  Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking ADDERALL XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

• Serious side effects have been reported with use of stimulant medicines such as ADDERALL XR, including:
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision
  • motion and verbal tics.  Patients with tics or Tourette's syndrome may experience a worsening of symptoms while taking ADDERALL XR.
  • slowing of growth.  Your child should have his or her height and weight checked often while taking ADDERALL XR. The doctor may stop treatment if a problem is found during these check-ups.

• The most common side effects reported in studies of ADDERALL XR were:

This is not a complete summary of safety information. For additional safety information, please see accompanying Full Prescribing Information and Medication Guide, including Warning about Potential for Abuse, and discuss with your doctor.

The Full Prescribing Information can be found here: http://pi.shirecontent.com/PI/PDFs/AdderallXR_USA_ENG.PDF

The Medication Guide can be found here: http://medguide.shirecontent.com/MEDGUIDE/PDFs/MG_AdderallXR_USA_ENG.pdf

ADDERALL® is a registered trademark of Shire LLC and under license to Duramed Pharmaceutical, Inc.

ADDERALL XR® is a registered trademark of Shire US Inc.

Notes to editors

SHIRE PLC

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 hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced 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: 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, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

SOURCE Shire plc

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