FDA Requests Data from Naloxone Manufacturers to Support OTC Switch - medtigo



FDA Requests Data from Naloxone Manufacturers to Support OTC Switch

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According to the American Journal Of Medicine, the FDA issued a call for data from naloxone producers on November 15, 2022, supporting a move from prescription to OTC versions. To be more specific, the FDA has advised that a nasal spray and an auto-injector be sold in stores.   

Naloxone is an opioid receptor antagonist that swiftly blocks or reverses opioid effects, restoring normal breathing and heart rate and preventing death in the event of an overdose. The most prevalent and vital disadvantage is mild withdrawal symptoms from opiates.

Non-cardiogenic pulmonary edema has been found in some people who have received naloxone (incidence rates range from 0.2% to 3.6%), generally within 4 hours of administration. Researchers feel that the potential benefit of naloxone outweighs the danger of pulmonary edema and that healthcare professionals should be aware of this.  

Even though more than 16 million people globally are addicted to opioids, the United States is responsible for more than 20% of these deaths, or more than 2.1 million people. From April 2020 to April 2021, 100,306 persons died in the United States of America due to a drug overdose, a 28.5% rise from the previous year; of these deaths, 75,673 were directly attributable to opioids.

Natural and semi-synthetic opioids, as well as synthetic opioids such as fentanyl, play a significant role. Because of its low price and greater potency, illicitly manufactured fentanyl is frequently combined with other recreational drugs, increasing the risk of lethal overdose for all users, especially first-time or infrequent users. Concerningly, fentanyl is currently present in around 60% of illegal substances.  

Approximately 20% of those who have overdosed on opioids also abuse alcohol, and more than half of people with chronic pain who are on opioids abuse alcohol. High-dosage opioid prescription holders are frequently exposed to the tragedy of seeing someone close to them overdose, yet only around 3% of these people have access to naloxone.

Healthcare practitioners should urge addicts’ families to get naloxone nasal spray or auto-injectors. Compared to epinephrine auto-injectors, which are used to treat anaphylaxis in medical situations, naloxone is frequently less than $100 at retail. Furthermore, in a news statement, Harm Reduction Therapies announced that 90% of the drug would be sold at cost to pharmacies and healthcare practitioners for around $18 per dosage, with the remaining 10% being donated.  

Patients with alcohol or drug use disorders, such as the 22.5 million Americans (or around 8.5% of the population), have an excellent benefit-to-risk ratio. Approximately two-thirds of people in syringe service programs, detoxification programs, and opioid treatment programs have observed an overdose, yet only approximately one-seventh have access to naloxone.

Patients undergoing substance abuse disorders should ideally have access to naloxone as part of their treatment programs. This drug can be taken in two ways: nasal spray or auto-injector. Regardless of the illness being treated, naloxone should be delivered to the patient if a high dose or extended half-life opioid is recommended.  

Naloxone, a medicine that may reverse the effects of opioids, should be widely available in nasal spray or auto-injector form wherever portable defibrillators are maintained because its usage might save the lives of patients who suffer cardiac arrest as a result of an opioid overdose.  


Historically, the United States has been more reactive than proactive in minimizing COVID-19 and gun violence, particularly among young Black men and schoolchildren. However, in the fight against opioid-related mortality, the time has come to be more forceful. The number of lives cruelly cut short by opioid overdoses in the United States is second only to the COVID-19 epidemic.

Providers should advise their drug-addicted patients and their family to maintain a naloxone nasal spray or auto-injector on hand. Increased naloxone delivery to first responders might save almost 20% of opioid overdose deaths, and its usage would benefit the medical community. Researchers conclude with a call to action for all health practitioners and state medical associations to ensure widespread distribution and easy access to naloxone before its upcoming FDA clearance. 


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