FDA Combating Opioid Drug Abuse

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FDA Combating Opioid Drug Abuse

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The United States Food and Drug Administration (FDA) has announced a new risk reduction program targeting opioid drugs. Opioids are a prescription synthetic drug used to mitigate moderate to severe pain. Many of the opioids are made for use as extended-release and long-acting medications. The FDA’s new plan is called Risk Evaluation and Mitigation Strategy or REMS for short.

The FDA’s REMS program will work to stem the increasing epidemic of prescription drug abuse in the United States. The REMS program is part of an overall effort by the White House to control prescription drug abuse in this country. On larger scale, the White House is collectively involving departments of Justice, Health and Human Services, Veterans Affairs, Defense, and other agencies to jointly develop a framework for reducing prescription drug abuse.

The FDA’s REMS plan will try to make prescription opioid and other drugs more effectively utilized and less abused. The program will educate doctors about proper pain management and patient selection. Improving patient awareness about how to use these drugs safely is a key aspect of REMS.

The FDA is requiring that the drug manufacturers share the responsibility of making opioids safer and less abused. Because opioids are such a dangerous class of drugs, they are responsible for many prescription drug fatalities, overdoses, and poisonings. Under REMS, opioid manufacturers will be required to give patients education materials that includes a medication guide with language explaining safe use and disposal. Developing a a uniform plan for implementing safer strategies will be the responsibility of all the drug makers. The FDA has asked the opioid makers to propose a REMS plan within 120 days.

Some of the brand names effected by the REMS plan are OxyContin, Avinza, Dolophine, and Duragesic. Generic names effected are hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine. Many of these prescriptions have been wrongly prescribed and abused. Opioids have lead to overdoses, addiction, and even deaths across the United States.

(See “Fentanyl Patch Dangers” in this blog June 27, 2012, “Fentanyl Pain Patch Recall” on March 21, 2012, and “Fentanyl Pain Patch Lawsuit” on March 21, 2012).

If you or a loved one has been harmed by an opioid prescription drug and has suffered overdose, poisoning, or death please call Longo Legal, PLLC toll free at (855) 566-4648 for a free no obligation consultation.

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