FDA Approves Prescription-Based Antidote for Overdose of Heroin, Other Opioids

The U.S. Food and Drug Administration (FDA) approved a “hand-held auto-injector” device for use with known or suspected opioid overdoses. Abuse of opioids, a group of drugs that includes many prescription painkillers, is becoming a serious problem in the U.S., and the FDA claims that opioid overdose has surpassed automobile accidents as the nation’s leading cause of injury deaths. The device, marketed under the brand name Evzio, delivers an injection of naloxone hydrochloride to counter or reverse the effects of opioid overdose. The FDA has stated that it hopes the availability of the device with a prescription will help prevent overdose deaths in emergency situations.

Opioid analgesics are a family of opiate-based drugs commonly used in prescription painkillers. They are derived from the same source as heroin and several other illegal narcotics. Common opioids include codeine, hydrocodone, morphine, and oxycodone. Opioids can be very addictive, so they are tightly controlled by the government. According to the Centers for Disease Control and Prevention (CDC), 16,651 people died of drug overdoses involving opioids in 2010, the most recent year for which statistics are available. This number accounts for about seventy-five percent of all drug overdose deaths that year. Many overdoses involve legally-obtained prescription painkillers. The total number presumably includes intentional and accidental overdoses, as well as dosage errors by a physician or pharmacist.

Evzio, as approved by the FDA, is a handheld device that injects naloxone hydrochloride, an “opioid antagonist” that is a common treatment for opioid overdose. Emergency responders often carry naloxone-containing products for use with suspected overdose victims. Since Evzio is only available with a prescription, it must be obtained in advance of any emergency situation. It is recommended for family members and caregivers of people using opioid painkillers in case of overdose. The device provides verbal instructions for use once it is turned on. A single dose of naloxone, according to the FDA, does not last as long as a typical opioid, so it cautions that the device is not a substitute for medical attention. What the device can do is delay further injury or death due to an overdose until medical attention is available.

Naloxone hydrochloride has not been the central subject of any recent reported personal injury cases, although several recent court opinions have mentioned several drugs that contain it as an ingredient. A wrongful death lawsuit alleged that a doctor was negligent, in part, by failing to administer a sufficient dosage of the naloxone-containing medication Narcan, resulting in the decedent’s death from surgical complications. McClain v. Brown, No. 13-P-555, mem. order (Mass. App., Mar. 18, 2014). A similar situation occurred in a case where a decedent’s cause of death was alleged to be opioid overdose, despite medical records indicating that several doses of Narcan were administered. Richardson v. Contra Costa County, No. A131855, order (Cal. App. 1st Dist., May 11, 2012). Neither case resulted in judgments for the plaintiffs.

The Maryland attorneys at Lebowitz & Mzhen can assist victims of medication errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. To schedule a free and confidential consultation to discuss your case, contact us today online or at (800) 654-1949.

More Blog Posts:

Prescription Errors and Computerized Physician Entry Order Systems, Pharmacy Error Injury Lawyer Blog, September 27, 2013
Electronic Health Records Create New Opportunities for Prescription Errors, Pharmacy Error Injury Lawyer Blog, June 10, 2013
Electronic Health Records May Increase Risk of Medication Errors, Pharmacy Error Injury Lawyer Blog, April 19, 2013
Photo credit: By Intropin (Own work) [CC-BY-3.0], via Wikimedia Commons.

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