Makers of certain opioid pain relievers including hydrocodone and oxycodone are being told by U.S. regulators to instruct doctors and patients that they should consider alternative treatments first.
The instructions, part of an effort to combat addiction and misuse, will be required on the labels of extended release and long-acting opioids, the Food and Drug Administration said in a statement today. New labels will indicate the drugs are only for people for whom alternatives are inadequate, the agency said.
Prescription painkillers were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, according to the Centers for Disease Control and Prevention. Drugmakers including Endo Health Solutions Inc. (ENDP) and Purdue Pharma LP are attempting to make tamper-resistant formulations that deter tablet crushing that gives addicts a greater high.
“These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices,” Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Endo makes the opioid Opana ER, while Impax Laboratories Inc. sells a generic of the same drug. Closely held Purdue Pharma also makes an extended-release version of OxyContin. Zogenix Inc. (ZGNX) is awaiting word on whether the FDA will approve its application for Zohydro ER, which would be the first single-ingredient hydrocodone drug.
The FDA also is requiring the companies to conduct new post-market studies on the abuse potential of their drugs and on the possibility that users develop an increased sensitivity to pain. The painkillers also will have to carry a boxed warning elevating the risk of neonatal opioid withdrawal syndrome that can occur in the mother’s womb, according to a consumer update also released today.
The FDA began requiring risk mitigation strategies of extended-release and long-acting opioids a year ago that included prescriber education efforts.
Hydrocodone combination drugs, such as Vicodin, are the most popular pharmacy drugs in the U.S. with more than 130 million dispensed prescriptions in 2011, according to IMS Health, a Danbury, Connecticut-based research company. The pills were also responsible for 115,739 overdose-related emergency room visits in 2010, double the tally in 2004, according to the Substance Abuse and Mental Health Services Administration.
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