Put warning labels on opioid painkillers, FDA directs drug makers

Put warning labels on opioid painkillers, FDA directs drug makers

Put warning labels on opioid painkillers, FDA directs drug makers

America is struggling with the epidemic of Opioid overdose with over 28,000 people succumbing to the abuse of prescription painkillers, heroin and other opioids in 2014 alone. To check the growing fatalities attributed to opioid overdose, the Food and Drug Administration (FDA) recently made it mandatory for addictive painkillers to be labeled about the dangers of their misuse.

The FDA announced on March 22, 2016 that immediate-release (IR) opioid prescription painkillers will now have to carry a warning about the possible dangers of abuse, addiction, overdose and deaths associated with painkillers most commonly used. Immediate-release opioid prescription pain medications are refer to drugs that need to be taken every four to six hours to alleviate the pain.

These prescription painkillers are used commonly to diminish temporary pain arising during treatment of fractures, wisdom tooth removal or other surgeries. The addictive properties of these medications when used in ways or dosages other than prescribed by doctors or taken by others for whom the medicines may not have been prescribed have made it imperative to add labels to more than 200 types of opioids, including the most commonly used drugs such as OxyContin, Demerol, Percocet and Vicodin.

Describing the action taken by the FDA to label prescription drugs as a combative measure against drug addiction in 2016, its commissioner Robert Califf said in a press release, “Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids.”

FDA guidelines

The strict guidelines issued by the FDA requires drug manufacturing companies to include clear instructions about the initial dosage and the necessary changes in quantity or frequency of the medicine during the entire therapeutic process.

The recommendations will advise patients to seek treatment if they find themselves physically dependent on them. This is based on the fact that opioids like methadone and buprenorphine are prescribed by medical practitioners to help patients accustomed to a life bereft of dependence on IR opioids.

The labels on the IR opioids would also alert pregnant women about the impact of these opioids on their babies and advise them against its prolonged use. Pregnant women relentlessly using this drug may give birth to babies afflicted with Neonatal Opioid Withdrawal Syndrome, a typical disorder in which the child can be born addicted to drugs.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” Califf said.

The instructions will also include warnings about the potential harmful impact of combining various drugs and its possible effects on the endocrine system which can in turn result in diminishing sex hormone levels.

Better late than never

The Morbidity and Mortality Weekly Report (MMWR), released by the Centers for Disease Control and Prevention (CDC) in January 2016, revealed a 137 percent increase in drug overdose deaths in the country since 2000, which includes a 200 percent rise in deaths attributed to opioid pain relievers and heroin.

The spike in heroin use and consequent addiction is an outcome of initial addiction to prescription painkiller opioids, which had resulted in law enforcement officials and healthcare providers criticize the FDA in adopting such a lax attitude while approving various drugs as a part of the curative procedures for treatment of pain.

In a recent move to put a cap on the painkiller abuse, the CDC on March 15, 2016 had announced a set of guidelines for doctors who treat patients complaining of critical pain. The guidelines suggested them to recommend their patients alternative and safer treatment approaches apart from recommending doctors to conduct a drug urine testing on their patients before handing out prescriptions for highly addictive painkillers like OxyContin, codeine and morphine.

The guidelines, recommendations and rules come at a time when America’s focus lies only on ways to curb drug addiction, though critics say that a lot of lives were lost since 2000 before the FDA took any step to combat the opioid issue.

Road to recovery

The complete recovery from addiction takes a lot of time. If you or your loved one is grappling with an opioid addiction, seek medical assistance immediately. You may call the Prescription Drug Addiction Help at 866-623-3847 or chat online to get in touch with an expert.