Cisapride (Propulsid - Janssen), a piperidinyl benzamide prokinetic drug, is now available in the USA for symptomatic relief of nocturnal heartburn due to gastroesophageal reflux disease. In Canada, cisapride is also marketed for treatment of gastroparesis.

Tegaserod maleate (teg a ser' od; Zelnorm - Novartis), a serotonin derivative, has received FDA approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Alosetron (Lotronex), which was withdrawn previously because of toxicity, will soon be available again for women with severe diarrhea-predominant IBS (Medical Letter 2002; 44:67).

The FDA has approved subcutaneous injection of methylnaltrexone (Relistor - Wyeth/Progenics), a selective mu-opioid receptor antagonist, for treatment of opioid-induced constipation in patients with advanced illness (such as incurable cancer or end-stage chronic obstructive pulmonary disease) who are receiving palliative care.

Current guidelines recommend use of a proton pump inhibitor (PPI) to decrease the risk of gastrointestinal bleeding in patients taking clopidogrel (Plavix) with aspirin. A recent issue of The Medical Letter considered whether omeprazole (Prilosec, and others) or other PPIs could interfere with the antiplatelet effect of clopidogrel. The conclusion was that patients taking both drugs should probably continue to do so until more data became available. Several new publications require reconsideration of that recommendation.

The FDA has approved mipomersen (Kynamro – Genzyme) and lomitapide (Juxtapid – Aegerion), each in addition to a low-fat diet and other lipid-lowering medications, to reduce cholesterol levels in patients with homozygous familial hypercholesterolemia (HoFH).

Berotralstat (Orladeyo – Biocryst), an oral plasma kallikrein inhibitor, has been approved by the FDA for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. The subcutaneously-injected plasma kallikrein inhibitor lanadelumab-flyo (Takhzyro) and the human plasma-derived C1 esterase inhibitors (C1INHs) Cinryze, which is given IV, and Haegarda, which is given SC, have been available for prophylaxis of HAE for years.

The FDA has approved icatibant (Firazyr – Shire), a selective bradykinin B2 receptor antagonist, for treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare autosomal dominant disorder (estimated prevalence 1:10,000-50,000) in which patients experience recurrent and frequently unpredictable attacks of angioedema lasting 2-5 days, typically involving the extremities, gastrointestinal tract, genitalia, face, oropharynx or larynx. Laryngeal edema may be life-threatening. HAE is usually caused by a mutation of the C1-inhibitor (C1-INH) gene. C1-INH is a serine proteinase...

The FDA has approved an oral tablet formulation of deferasirox (Jadenu [ jade' new] – Novartis) for once-daily treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients ≥2 years old or chronic iron overload in patients ≥10 years old with non-transfusion-dependent thalassemia syndromes. A once-daily, oral tablet for suspension formulation of deferasirox (Exjade) was approved in 2005 for the same indications.1 Jadenu and Exjade are the only once-daily oral formulations for iron chelation available in the US.No new clinical trials were required...

Cefuroxime axetil (Ceftin - Glaxo), an oral form of the second-generation parenteral cephalosporin cefuroxime (Zinacef), was recently marketed in the USA. Previously available oral cephalosporins are the first-generation drugs cephalexin (Keflex; and others), cephradine (Anspor; and others) and cefadroxil (Duricef; and others), and the second-generation cefaclor (Ceclor); second-generation cephalosporins have more activity against gram-negative bacteria.

Cefixime (Suprax - Lederle), an oral cephalosporin antibiotic, was recently approved for marketing by the US Food and Drug Administration. Claimed to be the first oral third-generation cephalosporin, the new drug is offered for once-a-day treatment of otitis media, pharyngitis, bronchitis and urinary tract infections.