Covidien supports FDA’s REMS for important class of pain medications

Covidien (NYSE: COV), a leading global provider of healthcare products, supports the U.S. Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) for an important class of pain medications.

“As the largest supplier of opioid pain medications in the United States, Covidien is dedicated to safe and appropriate use”

Today, the FDA sent letters to sponsors of long-acting and extended release opioid medications requiring a class-wide REMS. The FDA Amendments Act of 2007 gave the FDA the authority to require a REMS from manufacturers to ensure that the benefits of a drug product outweigh its risks.

As the largest supplier of opioid pain medications in the United States, Covidien sees the REMS for long-acting opioids as a foundation to minimize abuse, misuse and overdose of these drugs. Since Covidien's Mallinckrodt business introduced a branded extended release opioid in April 2010, the Company has implemented a comprehensive REMS for it that aligns closely with today's FDA guidance.

In addition, last fall the Company launched the C.A.R.E.S. (Collaborating and Acting Responsibly to Ensure Safety) Alliance^SM, a growing coalition of six patient, provider, and community organizations focused on providing resources and tools to support the responsible prescribing and safe use of prescription pain treatments.

"As the largest supplier of opioid pain medications in the United States, Covidien is dedicated to safe and appropriate use," said Herbert Neuman, M.D., Vice President, Medical Affairs and Chief Medical Officer, Pharmaceuticals, Covidien. "Access to these medications must be limited to patients suffering from chronic pain and possessing a valid prescription. We fully support the steps the FDA has taken with this REMS initiative, and we have demonstrated our commitment to patient safety with the voluntary tools developed and made available for patients, physicians and pharmacists through the C.A.R.E.S. Alliance. We look forward to working with the FDA to comply with its latest guidance."

The branded extended release opioid introduced by the Company in April 2010, was EXALGO® (Hydromorphone HCI) Extended Release Tablets (CII).