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Opioid pain killers: FDA takes steps to rein in abuse and harm

Kathleen Blanchard's picture
FDA to require strong warnings and monitoring for long acting opioids

The FDA is taking steps to keep opioid painkillers from harming people due to misuse, abuse and overdose. The agency is now requiring new safety labeling for extended-release opioids in an effort to help curb serious risks associated with narcotics.

In February, 2013, the CDC highlighted the number of deaths in the U.S from taking prescriptions drugs, finding that 77.2% of deaths were linked to opioid prescriptions.

In a September 10, 2013 press announcement the FDA’s Margaret A. Hamburg, M.D. said: “Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”

The goal is to help prescribers as well as consumers.

Future labeling on extended release (ER) and long-acting (LA) opioids will include clear language about the risks of the medications.

The FDA says the medications should only be used for patients requiring ‘around the clock’ pain management whose condition cannot be managed with alternative options such as short-acting opiates or non-narcotic pain relievers.

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What that means to patients already taking long-acting opioids is having an important discussion with your physician about using the medications safely, how to store them and how to properly dispose of unused medications.

The FDA is also calling on drug companies to conduct more studies about the safety of the medications.

In 2012, the Physicians Committee for Responsible Medicine petitioned the FDA to take a closer look at opioid safety more closely. The committee requested that the FDA change labeling from use for ‘moderate’ pain for non-cancer treatment, put a daily maximum limit on the amount of morphine prescribed for non-cancer pain of 100 mg and limit opioid prescribing recommendations to 90-day (for other than cancer).

Doctors are prescribing more drugs than in past decades, meaning the potential for interactions that could cause harm to health-care consumers. According to the NIH, 20 percent of people in the United States have used prescription drugs for non-medical uses that likely stems from widespread use of prescribed drugs.

In 2010, 7 million Americans reported using potentially dangerous drugs in the past month for non-medical reasons including barbiturates, sleeping pills and narcotics that were sometimes injected, smoked, chewed or snorted.

New and stronger opioid labeling and recommendations from the FDA to include:

  • Physicians will be reminded to assess individual patient risks, monitor patients closely and look for behavioral signs of abuse and misuse.
  • Labels will highlight the risks of addiction, overdose and abuse
  • Warnings for patients will state the drugs can cause severe respiratory distress that could be fatal
  • Warnings that opioids can be fatal from accidental ingestion by children will be included as well as opioid withdrawal symptoms for infants born to mothers taking the drugs during pregnancy.
  • Better tracking of adverse events

Source: FDA