FDA wants stronger warning labels for long-acting opioids

April 17 Thu Apr 17, 2014 1:08pm EDT

April 17 (Reuters) - The U.S. Food and Drug Administration is requiring labels of all long-acting opioids to say they should be used strictly for patients in severe pain, a response to surging overdoses and deaths each year from the widely used pain medicines.

The health regulator in September proposed the label changes, saying they were needed to highlight dangers of abuse and possible death, as well as risks to newborns of mothers taking the medicines. [ID: nL2N0H61AW]

The FDA, in a notice on its website on Wednesday, said it had approved the proposed changes, which will indicate that such drugs should only be used for severe pain. Currently, the labels indicate they are appropriate for patients with moderate and severe pain.

Opioids include formulations of morphine, oxycodone, fentanyl and Oxycontin, a long-acting form of oxycodone. They currently are widely prescribed, including for patients that have had dental or surgical procedures, or those complaining of back pain or headaches. Extended-release opioids will also fall under the proposed FDA guidelines.

Updated language on the drug labels will stress the medicines are meant for pain severe enough to require daily, round the clock, long-term opioid treatment, and only for those who have not had adequate pain relief from alternative medicines.

The labels will also include prominent warnings that chronic maternal use of the drugs can result in potentially fatal opioid withdrawal syndrome in newborns.

New opioids continue to be introduced, including a long-acting form of hydrocodone called Zohydro, made by Zogenix Inc, that has stirred controversy among U.S. politicians, prosecutors and medical societies.

The FDA approved Zohydro in October despite concerns by the agency's medical advisory panel over its potential for abuse. The 12-hour capsules can be crushed and inhaled or injected, making a full dose available immediately, according to critics.

Zogenix maintains the drug is a necessary option for patients with severe, around-the-clock pain who cannot tolerate acetaminophen.

Massachusetts Governor Deval Patrick last month announced a ban on Zohydro, formally declaring a public health emergency stemming from abuse of opioids in the state. But a federal court judge on Tuesday reversed the ban, saying Massachusetts was obstructing the FDA's constitutionally mandated authority.

More than 16,000 people in the United States died in 2010 from overdose deaths related to opioid abuse, according to the FDA, with long-acting forms of opioids playing a "disproportionate role" in drug abuse and deaths.

Although the updated language for long-acting opioids will be more restrictive, the FDA has acknowledged the agency really has no ability to ensure that doctors actually restrict their prescriptions to patients with severe pain.

"The FDA does not have the authority to regulate the practice of medicine, and health care practitioners may choose to prescribe a legally marketed drug, based on their clinical assessment," FDA spokeswoman Morgan Liscinsky said in September, when the label changes were proposed.

Another worrisome aspect of opioids is their link to burgeoning heroin addiction in the United States, in cities and towns of all sizes.

Healthcare and law enforcement experts say many people, including teenagers and young adults, become addicted to opioids found in their family medicine cabinets or elsewhere, and then turn to far-cheaper heroin when they no longer have access to the opioids or cannot afford them. (Reporting by Ransdell Pierson; Editing by Bernard Orr)