Reversal Spray Causes More Side Effects
A recently conducted study has revealed that a new, higher-dose nasal spray for reversing opioid overdoses does not save more lives than the previous standard dose. Published by the Centers for Disease Control and Prevention (CDC), the study focused on rural areas of New York state and compared the efficacy of an 8-milligram naloxone spray, which is twice as potent as the previous highest dose available. Although the higher-dose spray did not provide any additional benefit in terms of survival, it did cause more vomiting and other side effects, as detailed by the researchers.
Real-World Data
This study is the first to provide real-world data on the differences between the two doses of naloxone sprays. The higher-dose spray was approved two years ago in response to concerns raised by experts and patient advocates who noted that lower-dose antidotes were often administered multiple times to individuals suffering from overdoses. The research, conducted independently of the CDC, sheds light on the effectiveness of the higher-dose spray.
No Endorsement of Products
Dr. Michael Dailey of Albany Medical College, one of the authors of the study, emphasized that the findings did not lead him to endorse one product over another. However, he underlined the importance of recognizing the potential for increased side effects with the higher-dose spray. The study’s results should be taken into account when considering the use of naloxone sprays for opioid overdose reversal.
Study Methodology and Results
The researchers collaborated with the New York State Police, who respond to emergencies in rural and highway areas. Three troops were provided with 8-milligram sprays, while eight troops further from Albany were given 4-milligram doses. The study analyzed 354 instances in which troopers administered naloxone sprays between late March 2022 and mid-August 2023.
Regardless of the dose administered, 99% of overdose patients survived when troopers arrived while still alive. However, patients who received 4-milligram sprays often required more than one dose, averaging 1.67 doses equivalent to 6.7 milligrams. Similarly, those treated with the 8-milligram sprays received an average of 1.58 doses, equivalent to 12.6 milligrams.
Increased Side Effects
While disorientation and lethargy were common in both groups upon regaining consciousness, the study found that patients who received the higher-dose sprays experienced significantly more side effects. Approximately 38% of patients who received the higher dose exhibited signs and symptoms of withdrawal, such as vomiting, abdominal pain, sweating, shaking, and diarrhea. In contrast, only 19% of patients who received the lower dose experienced these problems.
It is crucial to consider these findings when evaluating the potential benefits and risks associated with different doses of naloxone sprays for reversing opioid overdoses.
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