FDA Seeks to Curb Painkiller Abuse

We recently wrote that a study revealed that prescribing opioids—A<"http://www.yourlawyer.com/practice_areas/defective_drugs">vinza, Butrans, Dolophine, Duragesic, Embeda, Exalgo, Kadian capsules, MS Contin, Opana ER, Oramorph, OxyContin, Palladone, and others—in high doses, increases the potential for accidental fatal overdose. Opioids are commonly prescribed for the treatment of pain.

The U.S. Food and Drug Administration (FDA), rejecting its expert advisory panel’s “strong” vote against its plan, launched an education plan to reduce long-lasting opioid abuse, said WebMD. Last July, the panel voted—24-to-10—to reject the plan and recommended stricter action to include short-action opioids, said WebMD.

The education plan, or “Risk Evaluation and Mitigation Strategy” (REMS) involves a medication guide and steps to provide patients and doctors with risk information, said WebMD, and hopes to minimize abuse of prescription drugs and keep these drugs from moving from patients to drug abusers.

The action includes mandating companies that create long-lasting or extended-release opioids develop a joint plan to teach patients and physicians on how to minimize addiction risks for these medications. The plan is a joint effort between the departments of Justice, Health and Human Services, Veterans Affairs, and Defense, noted WebMD.

“The agency concluded that there is a disproportionate safety problem associated with the extended-release and long-acting opioids which must be addressed, and will incorporate a step-wise approach to focus first on educating prescribers of extended-release and long-acting opioids,” the FDA said in a news release, WebMD quoted.

The plan is voluntary, noted WebMD, which explained that special training on how to properly prescribe opioids will not be mandated.

The agency is also seeking the passage of legislation by Congress to link mandatory physician training to receipt of the Drug Enforcement Administration number that doctors need to prescribe narcotics. The panel supported the legislation, wrote WebMD.

In addition to the brands named, generic versions include the Fentanyl extended-release transdermal system, Methadone (all versions, because methadone remains in the body for extended periods), Morphine extended-release tablets, and Oxycodone extended-release tablets, wrote WebMD..

The 2008 National Survey on Drug Use and Health revealed that just 7 percent of OxyContin users received their drugs from a valid prescription; 13 percent got theirs from a dealer or stranger and most, about 2/3rds, received the drugs from a friend or family member, wrote WebMD.

The recent study published in the Journal of the American Medical Association (JAMA), found that the incidence of death by fatal overdose has become a serious public health issue in the U.S. and that from 1999 to 2007, the rate of unintentional overdose death increased by 124 percent, largely because of increases in prescription opioid overdoses. Approximately 0.04 percent of patients receiving opioid therapy overdosed, according to the study. Higher maximum daily doses were associated with a higher overdose rate. That trend existed in all patient subgroups, such as those with chronic pain, acute pain, cancer, and substance use disorders.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.