Monday, July 27, 2015

FDA hears more pleas and concerns on prescription opioid painkiller labeling

The FDA is scheduled to complete on Friday a two-day meeting for further discussion on what the agency referred to as the "impassioned, sometimes heated, debate" over prescription opioid painkillers.

FDA hears more pleas and concerns on prescription opioid painkiller labeling

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The U.S. Food and Drug Administration started Thursday and was scheduled to complete on Friday a meeting for further discussion on what the agency referred to as the "impassioned, sometimes heated, debate" over prescription opioid painkillers.

The agency said in a note posted on its web site this week that it is in the middle of that debate. A link is here.

Law enforcement agencies, notably the Drug Enforcement Administration, would like greater restrictions on such drugs. Patients and some of their advocates who use the drugs properly are concerned about access to the medicine.

The problem is that such drugs are very addictive. The misuse and abuse of prescription painkillers led to more than 15,000 deaths in the last year of available results.

Dr. Douglas Throckmorton, a deputy director in the drug branch of the agency, was leading Friday's gathering. In January, he announced new plans to encourage drug companies to find new ways to make drugs to reduce abuse.

According to the agency, this week's meeting, "is focused on the approved labeling and how it is used in clinical practice. For example, to help guide potential changes to labeling, the agency is asking what data support a maximum daily dosage and restrictions on duration of use depending on type of pain (cancer and non-cancer) and how restricting use of these drugs to patients with severe pain alone might affect prescribing practices, patient access to pain medication, patient pain control and the abuse and misuse of opioid medicines."

The Wall Street Journal reported that supporters of the labeling change said it would help doctors and patients understand the real risks.

"Label limits would convey that, in general, benefits of high-dose or long-term opioid treatments do not outweigh risks," Hillary Kunins of New York City's health department told the Journal. A link to that story is here.

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About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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