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New FDA Head Outlines 'Forceful Steps' Against Opioid Crisis

TUESDAY, May 23, 2017 (HealthDay News) -- The new U.S. Food and Drug Administration commissioner has called on senior agency officers to develop "more forceful steps" to control the U.S. opioid epidemic.

On Tuesday, Dr. Scott Gottlieb, President Trump's pick for the agency, announced the formation of an opioid policy steering committee to explore and develop additional approaches to confront the crisis.

One solution, he said, is to cut back on unnecessarily prolonged painkiller use. Longer use increases the risk of opioid addiction.

"The majority of people who eventually become addicted to opioids are exposed first to prescription opioids," Gottlieb said in a blog post on the FDA site.

Misuse of potent painkillers such as OxyContin (oxycodone) and Vicoprofen (hydrocodone/ibuprofen) sends 1,000 Americans to emergency rooms each day. Opioid-related overdose deaths have quadrupled since 1999, he said.

Gottlieb acknowledged "a lot of good work" done to date. Now, he said, "I have asked my FDA colleagues to see what additional, more forceful steps we might take to curb prescription painkiller addiction."

Those steps might include shorter-term doses of legitimate painkillers. Only a few situations require a 30-day supply of painkillers, Gottlieb said.

"We want to make sure patients have what they need," he said. But he added, a two- or three-day course of treatment is sufficient in many cases.

Gottlieb wants the steering committee to consider mandatory education for health care professionals who prescribe powerful painkillers. Such instruction might outline appropriate prescribing practices, explain signs of abuse in individual patients, and suggest how to get addicted patients into treatment.

Another key question for consideration, Gottlieb said, is whether the FDA does enough to weigh the risk of abuse when it reviews new opioid drugs for market approval.

The budget President Trump submitted to the U.S. Congress supports $27.8 billion in drug control efforts. The budget proposal includes $12.1 billion for treatment and prevention.

The request also includes more than $15 billion for drug-related law enforcement efforts, said Richard Baum, acting director of the White House Office of National Drug Control Policy.

Research has shown that addiction risk starts the first day of painkiller use, Gottlieb said. In March, a study published by the U.S. Centers for Disease Control and Prevention linked one-day use of prescription painkillers to a 6 percent risk of continuing their use for more than one year. As use continued, so did the odds for addiction, Gottlieb said.

"For example, when a person's first exposure to opioids increases from one day to 30 days, that person's likelihood of continuing to use opioids after one year increases from 6 percent to about 35 percent," Gottlieb explained.

Addicts who can't get painkillers from a doctor sometimes turn to heroin, an illicit opiate. Gottlieb said recent research showed that three-quarters of heroin addicts from one study started with prescription painkillers.

The commissioner said he is seeking public input as well as professional advice on what additional steps FDA should consider to "get ahead of this crisis."

More information

The U.S. National Institute on Drug Abuse has more about opioid addiction.

SOURCES: U.S. Food and Drug Administration, blog post, May 23, 2017; White House Office of National Drug Control Policy, news release, May 23, 2017

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