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San Francisco Marin Medical Society Blog

FDA Panel Votes for Tighter Controls on Vicodin



A U.S. Food and Drug Administration panel voted today to place stricter controls on popular narcotic painkillers.

The 19 to 10 vote, which is advisory, will help the FDA decide whether to recommend moving drugs such as Vicodin, which contain the opioid painkiller, hydrocodone, from Schedule III to Schedule II under the Controlled Substances Act.

Ever since coming on the market 40 years ago, hydrocodone drugs have had fewer restrictions on them than drugs such as morphine and OxyContin, which contains the opioid oxycodone.

However, as overdose deaths and addiction rates soared over the past decade or so, putting stricter controls on hydrocodone has been the focus of efforts to reform the use of opioids and deal with America's opioid epidemic.

Stricter Schedule II status means that fewer prescriptions can be written at one time. For each visit to the doctor, a patient can get up to six months of prescriptions of Schedule III opioids such as Vicodin, compared with up to three months for Schedule II drugs.

Schedule II drugs also have stricter handling and storage requirements.

It was not known when the FDA would make a final decision on the issue.

Source: Journal Sentinel, January 25, 2013.



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