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Aggressive Efforts to Change Prescription Opioid Painkiller Labels

David W. Hodges
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Partner at Kennedy Hodges LLP practicing pharmacy error, medical malpractice and personal injury law
Posted on Sep 15, 2012

Recently, a petition to the Food and Drug Administration (FDA) was signed by medical and public health experts asking the FDA to change prescription guidelines for opioid painkillers to help stop drug abuse. The group, which included public health officials, researchers, and thirty-seven doctors, is asking U.S. health regulators for new painkiller labels to help people stop abusing addictive medications. 

The group is asking for:

  • Revised prescription labels for opioid painkillers
  • The addition of a maximum daily dose on the labels
  • Prohibiting these drugs for moderate pain symptoms
  • Stating there is a 90-day maximum for patients taking these drugs unless the patient is being treated for cancer

Although this group knows that changing opioid drug prescription labels would not prohibit doctors from prescribing this type of painkiller, they believe it could help stop pharmaceutical companies trying to promote these painkillers for non-approved uses. Unfortunately, drug companies have marketed opioids like methadone and oxycodone to treat pain; however, these drugs are highly addictive.

This group does not believe that drug companies should be allowed to market these addictive drugs as safe for treating long-term pain because patients can become addicted to them. The FDA cannot control the drug companies’ marketing, but they can change the medication labels.

Purdue Pharma, the makers of opioid OxyContin said, “The FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate.”  

The FDA told this medical and public health expert group that it would respond to their petition regarding opioid labels.

As medication error lawyers, we wish this group of doctors and public health experts the best in their efforts. 

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