Personal Injury Law

FDA Seeks Tougher Regulation Of Opioids

By Chrissie Cole

U.S. regulators announced Monday that they are stepping up efforts to reduce the misuse of 24 powerful painkillers, which cause hundreds of deaths each year.

Letters have been sent to 16 drug companies that collectively manufacture opioids that are subject to review, including oxycodone, methadone, morphine, fentanyl patches and related drugs.

The FDA is targeting both patch and pill forms, which generally feature extended-release formulas that are designed to give long-lasting effects. But, regulators warn that potency carries serious health risks.

“We are focusing on these products because they contain powerful doses of the drugs and they need to be used carefully and with caution,” said Dr. John Jenkins, the FDA’s chief of new drugs.

In 2007, 21 million prescriptions were dispensed for the 24 opioid products, used by 3.7 million Americans. The drugs are commonly used by patients that require constant treatment, such as cancer patients, for moderate to severe pain. While these types of drugs have the ability to relieve chronic pain, they can also be highly addictive and are often abused for their euphoric effects.

The agency is implementing this new program, because the “rates of abuse and misuse of opiates has risen over the past decade,” Jenkins said. The FDA Amendments Act of 2007 authorizes the agency to require Risk Evaluation and Mitigation Strategies, or REMS, "to ensure that the benefits of the drugs outweigh the risks," Jenkins said.

To that end, the FDA is working to strike an “appropriate balance” between legitimate patient needs for access to such drugs and the threat posed by their abuse and intentional/unintentional misuse.

The Substance Abuse & Mental Health Services Administration (SAMHSA) released data on Monday that showed adults aged 18 to 25 currently using pain relievers for non-medical reasons increased from 4.1 percent in 2002 to 4.6 percent in 2007. During that same period, non-medical use increased to 1.6% from 1.3% in Americans 26 and older.

Overall, 5.2 million people aged 12 years or older reported using prescription pain relievers non-medically in the past month in 2007.

An initial meeting between the agency and drug manufacturers is scheduled for March 3. #

Full post as published by InjuryBoard on February 10, 2009 (boomark / email).