The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children as young as 5 years old (Pfizer) or 6 years old (Moderna). The bivalent Pfizer vaccine had previously been authorized for use in persons ≥12 years old and the bivalent Moderna vaccine in persons ≥18 years old. Bivalent vaccines are not authorized for...

Topical minoxidil (Rogaine, and others), which is available over the counter, has been used for treatment of hair loss in men and women for more than 30 years. Recently published trials suggest that off-label use of a low dose of oral minoxidil may also be effective.

Palonosetron (Aloxi - Helsinn Healthcare SA, Switzerland, distributed in the US by MGI Pharma) is the fourth serotonin (5-HT3) receptor antagonist to become available in the US and the first to be approved by the FDA for prevention of both acute and delayed nausea and vomiting due to moderately emetogenic cancer chemotherapy. It is also approved for prevention of acute nausea and vomiting due to highly emetogenic drugs such as cisplatin (Platinol, and others). Aprepitant (Emend), a substance P/neurokinin-1 receptor antagonist, was approved last year for use with a 5-HT3 antagonist and...

The FDA has approved lubiprostone (Amitiza - Sucampo/Takeda), a chloride channel activator, for treatment of chronic idiopathic constipation in adults. The only other prescription drug approved by the FDA for this indication (in 2004 for adults <= 65 years old) is tegaserod (Zelnorm), a partial agonist of serotonin that is also approved for constipation-predominant irritable bowel syndrome in women. Of course, numerous over-the-counter products are available for treatment of constipation.

Atripla (Gilead/Bristol-Myers Squibb) is the first once daily, single-tablet combination of 3 antiretroviral drugs for treatment of HIV infection. Each tablet contains 600 mg of the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva), 200 mg of the nucleoside reverse transcriptase inhibitor (NRTI) emtricitabine (Emtriva), and 300 mg of the nucleotide reverse transcriptase inhibitor (NRTI) tenofovir DF (Viread). These drugs have been recommended for use together, if resistance testing confirms susceptibility, as an initial regimen of choice for treatment-na∩ve...

Silodosin (Rapaflo - Watson Pharmaceuticals), an alpha1a-adrenoreceptor selective antagonist, has been approved by the FDA for treatment of benign prostatic hyperplasia (BPH). Some medications for BPH are listed in the table on page 4. Alpha1 blockers are commonly used with 5a-reductase inhibitors such as finasteride, which can shrink the size of the prostate, but may take months to do so.

The FDA has approved the prostaglandin analog bimatoprost in a 0.03% solution (Latisse - Allergan) for increasing eyelash length, thickness and darkness in patients with hypotrichosis of the eyelashes.

The FDA has approved mannitol powder for oral inhalation (Bronchitol – Chiesi) as add-on maintenance treatment to improve pulmonary function in adults with cystic fibrosis (CF). This product has been available in Europe for the same indication since 2012. Another formulation of mannitol inhalation powder (Aridol) is approved in the US for assessment of bronchial hyperresponsiveness.

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.