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Physicians Ask FDA to Revise Prescription Label for Opioids


A group of doctors and public health experts has asked the Food and Drug Administration (FDA) to change prescription guidelines for opioids, to prevent prescription drug abuse, according to Reuters.

In a petition to the FDA, 37 doctors, public health officials and researchers asked the agency to prohibit use of opioids for moderate pain. They also called on the FDA to add a maximum daily dose, and only permit patients to take opioids for up to 90 days, unless they are being treated for cancer-related pain.

While a change in the label would not limit how doctors prescribe opioids, it would prevent drug companies from promoting the drugs for non-approved uses, the article notes. Some of the petitioners said the government needs to do more to address drug companies’ marketing that encourages physicians to prescribe opioids for chronic pain.

Dr. Andrew Kolodny, Chair of the Psychiatry Department at Maimonides Medical Center in New York, told the newspaper many of his patients start taking opioids for valid medical reasons, but become addicted when they take them for too long. “We don’t think drug companies should be allowed to advertise these drugs as safe and effective for long-term pain, if we know very well that they’re not,” said Kolodny, who is also President of Physicians for Responsible Opioid Prescribing.

Purdue Pharma, maker of OxyContin, said in a statement, “The FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate. We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges.”

1 Response to this article

  1. PWKaplan / July 26, 2012 at 1:06 pm

    Only doctors and the government would believe that changing the label (or even preventing drug companies from advertising) will reduce drug abuse. It demonstrates a complete lack of understanding about addiction, and what is needed to address the real problems faced by people with chronic pain, as well as addicts. This will be another regulatory fiasco, preventing people who need pain relief from getting the only drugs that provide it, and will not stop a single individual addict from obtaining opiates, nor will it prevent addiction. I’d like to meet the bright light whose idea it was to try to ban acetominophen #2 for anyone that doesn’t have cancer. It’s too bad these people can’t spend their time learning about what really works to stop addiction. Hint: it’s not more regulations.

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