The letter is the first formal call from public health advocates, who have been vocal on the matter since the FDA approved the first extended-release, pure hydrocodone pill on the U.S. market, Zohydro, against the recommendation of FDA medical advisors, according to the report.
Dr. Hamburg has been a supporter of broad painkiller — non cancer pain — use, noting reports that 100 million Americans may suffer from chronic pain, according to the report. She defended Zohydro’s approval by saying it fills an important gap in current medication offerings — other drugs, such as Vicodin, mix hydrocodone with drugs with liver-damaging potential, such as acetaminophen.
The controversy comes at a time during which opioids deaths have been on the rise: Deaths from painkillers tripled between 1991 and 2011 to about 17,000 deaths annually, according to CDC figures.
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