FDA Takes Step to Allow Drug Companies to Sell Naloxone Without Prescription

The U.S. Food and Drug Administration (FDA) has taken a step to make it easier for companies that make the opioid overdose antidote naloxone to sell the drug without a prescription, CNBC reports. Making naloxone available over-the-counter would lower costs and increase consumer access, the agency said.

Drugmakers that want to take a drug already approved for prescription use and make it available over-the-counter must develop a label that is easy for consumers to understand. The FDA has created two model labels for naloxone—one for the nasal spray version of the drug and one for the auto-injector version.

Drug companies also must conduct studies to show consumers can understand how to use the products without a physician’s supervision. The FDA hired an independent research firm to study more than 700 people who might use naloxone if they use heroin or if a friend uses prescription opioids. The study found participants understood the model labels.

How to Use Naloxone to Reverse Opioid Overdose and Save Lives

A variety of drugs and drug combinations carry the risk of fatal overdose. Emergency protocol for any suspected overdose includes calling 911. However, in the case of opioids, which includes heroin and prescription pain medications like Vicodin, OxyContin and Percocet, naloxone (also known by the brand name Narcan) can reverse an overdose, potentially saving a loved one’s life.

Naloxone- International Overdose Awareness Day 2017

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