FDA, CDC Probing Painkiller Overdoses

Two federal agencies are collaborating on the issue of opioid use and related accidental, often fatal, overdoses.  AMedNews reported that the agencies are hoping to find a way to ensure the painkillers are both save and available.

“We know that these drugs have important therapeutic uses,” said Douglas Throckmorton, MD, the Food and Drug Administration’s (FDA) deputy director for Drug Evaluation and Research. “We also know that there’s abuse. There are overdoses. There’s diversion that we don’t want to happen,” he added, said AMedNews.

Some states have established prescription drug monitoring programs, some medical societies have conducted studies and urged more education, and, now, the FDA and the Centers for Disease Control and Prevention (CDC) will be working together to look at the trend in accidental opioid overdoses, AMedNews reported.

Meanwhile, Fentora, a powerful narcotic pain killer in the opioid class is the subject of three separate investigations and has been linked to four deaths, which prompted Cephalon Inc., Fentora’s maker, to issue warning letters to doctors about the deaths, which it claims were due to improper patient use.  “Physicians need a practice environment that allows for the appropriate use of controlled substances, including those used for pain management, while minimizing inappropriate use and diversion,” said Edward L. Langston, MD, immediate past chair of the AMA Board of Trustees.  For instance, <"https://www.yourlawyer.com/topics/overview/fentora_overdose">Fentora  and  Actiq—both in the fentanyl family, highly addictive, and 80 times more potent than morphine—received FDA approval for use in cancer patients only, but are known to be prescribed “off-label” for headaches and back pain.  Fentanyl is considered a Class II substance by the Drug Enforcement Administration (DEA), meaning it is associated with a high potential for abuse and a risk for fatal overdose.

The upward trend in opioid use for non-cancer chronic pain began in recent years as did the related rise in misuse and negative effects, noted AMedNews, which added that accidental overdose deaths from narcotics or hallucinogens in the 15-64 years age range rose 5,921 in 1999 to 10,829 in 2005, an 83 percent increase.  Unintentional overdoses not resulting in fatality saw a 44 percent increase from 376,611 to 542,372 accidents in the same time frame and within the same age group.  AMedNews said that opioids were the prevailing factor in all the incidences.

According to the FDA, it and the CDC will support research efforts, by way of grants, with opioids being the main focus, said AMedNews.  The CDC will provide $350,000 in funding to two grantees; the money to be provided by the FDA remains unknown at this time.  “These grants will help us identify promising strategies to combat this epidemic of prescription drug overdoses,” said Len Paulozzi, MD, MPH, a medical epidemiologist in the CDC’s unintentional injury prevention division at its National Center for Injury Prevention and Control.  “The prescription drug abuse problem is enormous and … it seems to be getting worse,” he added, quoted AMedNews.   “Those overdosing on opioids are just showing up in the medical examiner’s office dead, but a piece of solving this problem is figuring out how to get poison centers involved,” said William Hurley, MD, the WPC medical director; the WPC is applying for one of FDA/CDC grants, said AMedNews.

One of the contributing factors to the rise in opioid overdose and deaths is doctor shopping, which according to the Daily Progress, is the practice of moving from one doctor or emergency room to another to collect prescriptions and ensure a supply of drugs when one doctor or facility catches on to the abuse.  One of the drug clinics cited in the piece said that the vast majority of its patients—a whopping 95 percent—come in because of opioid addictions.