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New vaccine for smallpox, monkeypox

The FDA has approved Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults age 18 and older determined to be at high risk for smallpox or monkeypox infection. Smallpox, a highly contagious and often fatal disease, is caused by the variola virus. Signs and symptoms include fever, headache, and a characteristic raised rash. Monkeypox, a rare disease found in tropical African rainforests, causes similar but usually milder signs and symptoms and may be transmitted by infected rodents and primates. Although monkeypox does not occur naturally in the US, an outbreak occurred in 2003.


The routine vaccination of US children against smallpox ended in 1972 and smallpox was eradicated worldwide in 1980. Consequently, most people today have no natural immunity. "Although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect," said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research. Jynneos has been added to the Strategic National Stockpile, the nation's largest supply of potentially lifesaving drugs and medical supplies for use in a public health emergency.


The safety of Jynneos was assessed in more than 7,800 individuals who received at least one dose of the vaccine. No safety concerns that would require a Medication Guide were identified. Jynneos is administered in two subcutaneous injections given 4 weeks apart.


Source: US Food and Drug Administration. FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox. News release. September 24, 2019.



Coming soon: Insulin in a pill?

Insulin and many other drugs cannot be given orally because they are degraded in the gastrointestinal (GI) tract before they can take effect. Many patients with diabetes must inject insulin daily or rely on oral antidiabetic drugs, which are more chemically stable, painless to administer, and do not generate biohazardous needle waste.


Hoping to confer the advantages of oral administration to insulin and other injectable drugs, scientists are developing a novel oral delivery system called the luminal unfolding microneedle injector. This ingestible capsule protects insulin as it passes through the stomach to the small intestine. There, the higher pH triggers it to break open and release three folded arms. Each arm contains patches of 1 mm microneedles that attach to the intestinal wall and release insulin for uptake into the bloodstream. Testing indicates that the capsule can carry an insulin dose comparable to that of an injection, and that the insulin is absorbed into the bloodstream even faster than a dose injected into subcutaneous tissue. The microneedles are designed to dissolve within hours to prevent GI obstruction.


Giovanni Traverso, a senior author of the study, notes that the small intestine lacks pain receptors, allowing for painless microinjection of drugs. "A lot of this work is motivated by the recognition that both patients and healthcare providers prefer the oral route of administration over the injectable one," he says. He and his colleagues believe the delivery device will be applicable to many other agents besides insulin, such as hormones, enzymes, antibodies, and even vaccines.


This research is funded by Novo Nordisk and the National Institutes of Health.


Sources: Abramson A, Caffarel-Salvador E, Soares V, et al. A luminal unfolding microneedle injector for oral delivery of macromolecules. Nat Med. [e-pub ahead of print October 7, 2019] Massachusetts Institute of Technology. New capsule can orally deliver drugs that usually have to be injected. News release. October 7, 2019.



Pharmacists reduce time to treatment in ED

In patients taking oral anticoagulants who are experiencing life-threatening bleeding or who need emergency surgery, rapid reversal of anticoagulation is critical. To determine if having a pharmacist present speeds the process, researchers conducted a retrospective cohort study that included 252 patients who received four-factor prothrombin complex concentrate (4F-PCC) for life-threatening bleeding or an urgent procedure in the ED from 2014 to 2018. Patients with pharmacists at the bedside (PharmD group, n = 50) were compared with patients cared for by physician teams (control group, n = 66). The anticoagulant taken by most patients was warfarin. The most common life-threatening bleeding event was intracranial hemorrhage. The primary outcome was time from ED presentation to 4F-PCC administration.


The findings showed that median time to 4F-PCC administration was significantly shorter in the PharmD group (66.5 versus 206.5 minutes), and that having a pharmacist at the bedside was the only factor independently associated with this reduction in time. No significant difference was found between the groups in hemostasis or mortality, but patients in the PharmD group had a shorter length of stay in both the ICU (2 versus 5 days) and hospital (5.5 versus 8 days).


Source: Masic D, Hidalgo DC, Kuhrau S, Chaney W, Rech MA. Pharmacist presence decreases time to prothrombin complex concentrate in emergency department patients with life-threatening bleeding and urgent procedures. J Emerg Med. [e-pub ahead of print August 22, 2019]



Tramadol raises the risk of hypoglycemia

Compared with most other opioids, tramadol is associated with a 10-fold greater risk of hypoglycemia, according to an analysis of more than 12 million adverse event reports submitted to the FDA in patients without concurrent medication use and comorbidities. Tramadol is a centrally acting weak synthetic opioid analgesic.


In addition to 11 widely prescribed opioids, researchers evaluated adverse reactions reported for some similar-acting nonopioid drugs: four serotonin-norepinephrine reuptake inhibitors such as duloxetine, and five N-methyl-d-aspartate receptor modulators such as ketamine. They found a significantly greater risk for hypoglycemia with tramadol in patients without diabetes compared with almost every other drug studied. The exception was methadone, which had an association with hypoglycemia similar to that of tramadol.


The authors suggest monitoring glucose levels in patients with and without diabetes taking tramadol or methadone and considering alternative medications for patients at risk for hypoglycemia or any complications associated with hypoglycemia.


Source: Makunts T, U A, Atayee RS, Abagyan R. Retrospective analysis reveals significant association of hypoglycemia with tramadol and methadone in contrast to other opioids. Sci Rep. 2019;9(1):12490.