The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the FDA in 2020 for treatment of COVID-19 in hospitalized patients.

The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by IM injection for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of severe allergy that prevents their vaccination against COVID-19 or moderate or severe immune compromise (see Table 1). They are the first drugs to be authorized by the FDA for this indication. Two other pairs of antibodies, bamlanivimab plus etesevimab (Lilly) and casirivimab plus imdevimab (REGEN-COV), are authorized for post-exposure prophylaxis of COVID-19.

The antiplatelet drug clopidogrel (Plavix, and others) reduces major cardiovascular events, but can cause bleeding. Proton pump inhibitors (PPIs) are often used with clopidogrel to prevent gastrointestinal bleeding, however, some evidence suggests that PPIs may interfere with the activation of clopidogrel and diminish its antiplatelet effect. FDA-approved labeling recommends avoiding concurrent use of the PPIs omeprazole and esomeprazole with clopidogrel.

On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer) for oral treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh at least 40 kg and are at high risk of progressing to severe disease, including hospitalization or death. Paxlovid was the first oral antiviral drug to be authorized in the US for treatment of COVID-19; Merck's oral antiviral drug molnupiravir was granted an EUA for treatment of COVID-19 on December 23, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the FDA in 2020 for treatment of COVID-19 in hospitalized patients.

Many drugs can cause psychiatric symptoms, but a causal connection is often difficult to establish. Psychiatric symptoms that emerge during drug treatment could also be due to the underlying illness, previously unrecognized psychopathology, or psychosocial factors. The withdrawal of some drugs can cause symptoms such as anxiety, psychosis, delirium, agitation or depression.

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The FDA recently warned that accidental ingestion of the antitussive benzonatate (Tessalon Perles, and others) by children less than 10 years old can be fatal.1 This widely prescribed oral agent, which has been available in the US since 1958, can also cause severe morbidity and death in older children and adults, and not only in overdosage.

Benzonatate is a polyglycol derivative structurally related to procaine and tetracaine. It acts peripherally on stretch receptors in the lower respiratory tract to suppress the cough reflex. If the patient chews or sucks the liquid-filled capsules or "softgels", the drug can cause laryngospasm, bronchospasm and circulatory collapse. Adverse effects that can occur after swallowing an intact capsule include a feeling of numbness in the chest, mental confusion, a sensation of burning in the eyes, and visual hallucinations.

Taken in overdose, benzonatate can rapidly cause seizures, cardiac arrhythmias and death. Serious adverse outcomes reported to the National Poison Center between 2000 and 2006 occurred in 116 patients (41 in children <6 years old), with 4 deaths.2 The 5 children known to the FDA who died from benzonatate ingestion were ≤2 years old and some apparently took only one or two capsules. In one well-documented case report, a 17-year-old girl who intentionally took 10 or more 200-mg capsules developed seizures, cardiac arrest from which she was resuscitated, and then blindness, which persisted.3 When a cough suppressant is truly necessary, dextromethorphan or even codeine might be a safer choice.

1. FDA. FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age. Available at www.fda.gov/Drugs/DrugSafety/ucm236651.htm. Accessed January 27, 2011.

2. ML Winter et al. Benzonatate ingestion reported to the National Poison Center Database System (NPDS). J Med Toxicol 2010; 6:398.

3. V Cohen et al. Cardiac arrest with residual blindness after overdose of Tessalon (benzonatate) Perles. J Emerg Med 2009 Nov 4 (epub).

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The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody regimens are authorized for the same indication: casirivimab (REGN10933) and imdevimab (REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016) administered together. The FDA revoked its EUA for bamlanivimab alone in April 2021 because an increasing percentage of COVID-19 cases in the US are being caused by SARS-CoV-2 variants that are resistant to monotherapy with the drug.

The US Advisory Committee on Immunization Practices (ACIP) recommends routine use of the following vaccines in adults residing in the US: influenza, tetanus/diphtheria alone (Td) and in combination with acellular pertussis (Tdap), measles/mumps/rubella (MMR), varicella (VAR), herpes zoster (RZV; ZVL), human papillomavirus (HPV), and pneumococcal conjugate (PCV13) and polysaccharide (PPSV23) vaccines. For adults with certain medical conditions or occupational, behavioral, or other risk factors, hepatitis A (HepA), hepatitis B (HepB), meningococcal (MenACWY; MenB), and Haemophilus influenzae type b (Hib) vaccines are also recommended. Recommendations for vaccination against seasonal influenza and vaccination of travelers are reviewed separately.

On November 19, the FDA expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a booster dose for all adults ≥18 years old after primary immunization with either the same COVID-19 vaccine or a different one. Booster doses of these vaccines were previously authorized only for select populations (age ≥65 years or persons at high risk for severe COVID-19). The EUA for the adenovirus-based vaccine manufactured by Johnson & Johnson was amended in October 2021 to include administration of a booster dose for all adults ≥18 years old after primary immunization with the Johnson & Johnson vaccine.

Influenza is generally a self-limited illness, but complications such as pneumonia, respiratory failure, and death can occur, especially in patients at higher risk for complications (see Table 1). Antiviral drugs recommended for treatment and chemoprophylaxis of influenza this season are listed in Table 2. Updated information on influenza activity and antiviral resistance is available from the CDC at www.cdc.gov/flu.