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Bulletin Today

Image of a man in a hospital bed

What’s the longer-term effect of treatment for critically ill patients with COVID-19?

Researchers of a new study published December 16, 2022, in JAMA found that among critically ill patients with COVID-19, there was a high likelihood of improved 180-day mortality among patients treated with IL-6 receptor antagonists and antiplatelet agents.
Researchers used data from the ongoing REMAP-CAP trial to gauge the longer-term effectiveness of 6 categories of treatment used among critically ill patients with COVID-19: immune modulators, convalescent plasma, antiplatelet therapy, anticoagulation, antivirals, and corticosteroids. For the study, patients were randomized to receive one or more of these treatment interventions.

“When considered with previously reported short-term results, the findings indicate that initial in-hospital treatment effects were consistent for most therapies through 6 months,” concluded the study authors.

Specifically, they were looking at longer-term mortality, disability, and health-related quality of life.

The REMAP-CAP trial included critically ill adult patients with COVID-19 enrolled between March 9, 2020, and June 24, 2021. Patients came from 14 countries.

The primary outcome was survival through day 180. Of the 4,869 randomized patients, 84.3% had known vital status and 63.1% were alive at 180 days.

According to the study, the pooled IL-6 receptor antagonists and antiplatelet treatment groups each had a high probability of benefit compared with the control groups. The probability of benefit for fixed-dose corticosteroids and shock-dependent corticosteroids compared with no corticosteroids was 61.6% and 57.1%, respectively. However, the corticosteroid domain was stopped early on the basis of external evidence.

In contrast, the likelihood of trial-defined statistical futility was high for therapeutic anticoagulation in critically ill patients, convalescent plasma, and lopinavir/ritonavir. In addition, there was a high likelihood of harm for hydroxychloroquine and its combination with lopinavir/ritonavir. ■


Image of homepathic items

FDA issues guidance on homeopathic drugs

A final guidance document from FDA details the agency’s efforts to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States. There are currently no FDA-approved products labeled as homeopathic.

The agency has created a risk-based approach under which it aims to prioritize certain categories of homeopathic drug products that potentially pose a greater risk to public health, such as those intended for populations at higher risk for adverse reactions as well as ophthalmic and injectable products, as the routes of administration for these products bypass some of the body’s natural defenses.

FDA noted it expects many homeopathic drug products will fall outside the types of drug products it plans to prioritize for enforcement and regulatory action. ■

Image of a pill with a skull and cross bones on it.

Drug overdose deaths among teenagers surged during the COVID-19 pandemic

A new CDC report found that monthly drug overdose deaths nearly tripled among adolescents aged 10 to 19 years during the first 2 years of the COVID-19 pandemic. Deaths increased from 31 to 87 per month from July 2019 to May 2021 before declining to 51 per month in December 2021.

“Although deaths appear to have begun declining in late 2021, they are still alarmingly higher than in 2019,” wrote the study authors in CDC’s Morbidity and Mortality Weekly Report.

More than 2,200 adolescents fatally overdosed during the 2.5-year period, 96% of whom were teens aged 15 to 19 years. Fentanyl was implicated in 84% of the deaths, while opioid analgesics of any type were involved in 91% of deaths.

Among adolescents, fentanyl deaths more than tripled from 31 per month in July 2019 to a peak of 87 per month in May 2021, declining to 44 per month in December 2021. Approximately 70% of the fatalities were among males and 30% in females. Roughly 60% of those who died were white, 21% were Hispanic, and 13% were Black.

An estimated 25% of the adolescent overdose deaths may have involved counterfeit drugs resembling oxycodone (OxyContin—Purdue Pharma) or alprazolam (Xanax—Pfizer). Both often contain fentanyl.

“Whether adolescents intended to take legitimate pharmaceutical medications or were aware pills were counterfeit is unclear,” the authors wrote.

Roughly 41% of those who overdosed had a prior history of mental health issues, with about 24% reporting prior mental health treatment; 19% diagnosed with depression; and 15% had a prior history of suicidal or self-harm behavior.

The authors stressed the importance of teaching teenagers about the risks of fentanyl and its likelihood of contaminating counterfeit drugs. ■


An image of the structure of mifepristone

FDA gives certified pharmacies green light to dispense mifepristone

In early January 2023, FDA announced modifications to the REMS for mifepristone (Mifeprex–Danco Labs). The revisions would allow pharmacies to become certified to dispense this FDA-approved drug to patients with a prescription, as long as they comply with the certification requirements.
Among other requirements, a certified pharmacy must ensure certain processes and procedures are in place, and dispense, including by mail-order, within a specific timeframe.

The U.S. Postal Service announced on December 23, 2022, that current law supports delivery of mifepristone and misoprostol through the mail.

Some states, however, still ban or restrict access to mifepristone following the Supreme Court’s recent Dobbs v Jackson decision overturning Roe v Wade. ■

Image of the chemical structure of naloxone

A second naloxone nasal spray gets FDA fast track for OTC clearance

A nasal spray version of naloxone (Rivive—Harm Reduction Therapeutics) is now on the FDA fast track for OTC clearance. According to the manufacturer, FDA is aiming for April 28, 2023, as an approval date after priority review.
With cost and access in mind, Harm Reduction Therapeutics also noted that it would price the overdose antidote at about $18 per dose for sale to pharmacies, public-sector workers, and advocacy organizations. The nonprofit company will also donate one-tenth of its production, which is slated to reach 2 million doses annually.

This approval shortly follows FDA’s decision in late 2022 to put an OTC version of naloxone nasal spray (Narcan—Emergent BioSolutions) on the fast track to approval. That opioid overdose antidote tentatively could receive clearance early this spring.

Another company, Pocket Naloxone Corp., has submitted its application for a nasal-swab version of naloxone that it says would be more affordable than the sprays and faster acting than prescription formulations. ■



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