The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.

Many fermented foods contain tyramine as a byproduct formed by the bacterial breakdown of the amino acid tyrosine; it can also be formed by para-hydroxylation of phenylethylamine or dehydroxylation of DOPA and dopamine. Tyramine and some other amines found in food can cause hypertensive reactions in patients taking monoamine oxidase (MAO)inhibitors.

Two new platelet glycoprotein IIb/IIIa receptor antagonists have been approved for marketing by the US Food and Drug Administration (FDA). Eptifibatide (ep ti fi' ba tyde; Integrilin - Cor, Key) is approved for use in acute coronary syndromes (unstable angina or non-Q-wave myocardial infarction) or percutaneous coronary intervention (angioplasty or atherectomy). Tirofiban (tye roe fye' ban; Aggrastat - Merck) is approved for acute coronary syndromes, but not for angioplasty without an acute coronary syndrome. Abciximab (ReoPro), a monoclonal antibody glycoprotein IIb/IIIa receptor...

Several new treatments are now available for actinic keratoses (AKs), scaly pink papules commonly found on sun-exposed areas of the face, scalp, forearms and dorsal surface of the hands, particularly in the elderly. Some AKs regress spontaneously, but a few may progress to squamous cell carcinoma; the risk of progression has been estimated to be about 0.25% to 1% per year (EWB Jeffes III and EH Tang, Am J Clin Dermatol 2000; 1:167).

Oxaliplatin (Eloxatin -Sanofi-Synthelabo) has been approved by the FDA for use in combination with fluorouracil (5-FU; Adrucil, and others) and leucovorin (LV; Wellcovorin) for patients with metastatic colorectal cancer whose disease has recurred or progressed despite treatment with 5-FU/LV plus irinotecan (Camptosar - Medical Letter 1997; 39:8).

The FDA has approved emtricitabine/tenofovir (Truvada - Gilead) and abacavir/lamivudine (Epzicom - GSK), two new fixed-dose combinations of nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), for once-daily use in treatment of HIV infection. Two other fixed-dose NRTI combinations were previously approved for twice-daily dosing. Dual NRTI therapy is generally used in either an NNRTI (non-nucleoside reverse transcriptase inhibitor)-based or a PI (protease inhibitor)-based regimen.

Options in screening for colon cancer include fecal occult blood tests, flexible sigmoidoscopy, colonoscopy, computed tomography (CT) colonography and fecal DNA tests. Since the last Medical Letter article on this subject, more data have become available on colonography.

The FDA has approved the new aminoglycoside antibiotic plazomicin (Zemdri – Achaogen) for IV treatment of adults with complicated urinary tract infections (cUTIs). Plazomicin is active against multi-drug- resistant Enterobacteriaceae, including strains resistant to other aminoglycosides.

Three products are currently available in the US for treatment of high-risk,1 nonhospitalized adults with mild to moderate COVID-19: oral ritonavir-boosted nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and oral molnupiravir (Lagevrio). Remdesivir is FDA-approved for such use; nirmatrelvir/ritonavir and molnupiravir are available under an FDA Emergency Use Authorization. Because the pivotal clinical trials of these products for outpatient use were conducted in patients who were not vaccinated against COVID-19, some clinicians have questioned whether they can benefit vaccinated...

Donanemab-azbt (Kisunla – Lilly), an IV amyloid beta-directed monoclonal antibody, has been approved by the FDA for treatment of Alzheimer's disease (AD). The label states that the drug should only be started in patients with mild cognitive impairment (MCI) or mild dementia. Donanemab is the third IV amyloid beta-directed monoclonal antibody to be marketed in the US. Lecanemab (Leqembi – Biogen/Eisai) was approved by the FDA in 2023 for the same indication as donanemab. Aducanumab (Aduhelm – Lilly) was granted accelerated approval in 2021, but it was withdrawn from the market...