FDA Requires New Safety Warnings on the Use of Opioids

The Food and Drug Administration (FDA) warns against the prescription drug abuse epidemic in the United States. FDA released a statement on Tuesday saying that all fast-acting opioid pain medicines will be required to have the strongest warning about their risks including the risk for abuse, addiction, overdose and possibly death.

Painkillers are classified into two, the extended release and the immediate release. Extended release is the kind of painkiller that has more pain-killing opioid per dosage while the immediate release which has less opioid in it but requires to be taken more frequently. The FDA said that there is at least 90 percent of opioid prescriptions are for immediate-release painkillers.

FDA issued a "black box" warning (the strongest FDA warnings) which aims to educate doctors as they are the ones prescribing these drugs to patients. "This epidemic touches all corners of our nation and is devastating individual lives, communities and our nation," said FDA Commissioner Robert Califf during a briefing for reporters. He called the epidemic the "most urgent and devastating public health crisis facing our nation."

According to npr.org, Califf explained that the FDA warned doctors and patients about the dangers of the drugs while making sure that they remain available for patients who need them to cope with pain. But, Califf emphasized that these drugs be kept to use for severe pain where no alternative medications are available.

CNN explained how this warning will play out for the consumers.

As soon as consumers get their prescription filled, the bottle should have a notice that indicates there is a black box warning for the drug. The consumer would need to go to the manufacturer's website for more details. Furthermore, the FDA also encouraged pharmacists to give patients medication guide which should have a consumer-friendly language that will explain the risks of the drugs.

Along with this, the FDA also said that all new instant-release drugs should have a drug guide like this, and it is up to the pharmacist to relay this information to consumers.

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