Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article on this subject, some new data have become available.

The FDA has approved Diclegis (Duchesnay), a fixed-dose, delayed-release combination of the H1-antihistamine doxylamine and the vitamin B6 analog pyridoxine, for treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. It is only available by prescription. Doxylamine and pyridoxine, both currently available over the counter, were previously available by prescription in a fixed-dose combination (Bendectin) for morning sickness. Bendectin was voluntarily withdrawn in the US in 1983 because of claims of teratogenicity that have since been...

New guidelines from The National Cholesterol Education Program recommend, as a therapeutic option, lowering treatment goals for LDL cholesterol (LDL-C) from <100 mg/dL to <70 mg/dL for patients at very high risk for coronary heart disease and from 130 mg/dL to <100 mg/dL for those at moderately high risk. A likely consequence of these recommendations is increased use of statins and use of higher doses with a concomitant increase in adverse effects.

The Medical Letter reported last year that sildenafil (Viagra - Pfizer) appeared to be effective for idiopathic pulmonary arterial hypertension (PAH), but confirmation from a controlled trial was needed. Now the results of such a study are about to be published, and the drug has been approved by the FDA for this indication under the trade name Revatio.

A transdermal patch formulation of methylphenidate (Daytrana - Noven/Shire) has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥ 6 years old. Like other methylphenidate products, the patch is a schedule II controlled substance. According to the manufacturer, it will be available in pharmacies by the end of June.

A recent advertisement for the proton pump inhibitor (PPI) lansoprazole (Prevacid - TAP) suggests that children who cough at night, complain of abdominal pain, refuse to eat, or have a bad taste in their mouths may all have gastroesophageal reflux disease (GERD). A Bunny's Tummy Trouble, a children's book about GERD published by TAP, is now available as a patient handout in pediatricians' waiting rooms. The use of acid-suppressive drugs in infants and children has increased markedly in recent years and many of these drugs are now available in child-friendly formulations. A table in the article...

The FDA has approved Cabenuva (ViiV Healthcare), an extended-release formulation of the new integrase strand transfer inhibitor (INSTI) cabotegravir copackaged with an extended-release formulation of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine, as a once-monthly complete regimen for intramuscular (IM) treatment of adults with HIV-1 infection who are virologically suppressed (HIV-1 RNA...

Eravacycline (Xerava – Tetraphase), a new synthetic tetracycline antibiotic, has been approved by the FDA for IV treatment of complicated intra-abdominal infections (cIAIs) in adults. Eravacycline is structurally similar to tigecycline (Tygacil, and generics), a broad-spectrum tetracycline approved by the FDA for IV treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia. A higher rate of mortality has been reported with use of tigecycline compared to other antibacterial drugs; it should be used only...

Implantable cardioverter defibrillators (ICDs) are widely used in patients at risk for sudden cardiac death (SCD) because these devices have been highly successful in terminating life-threatening ventricular arrhythmias and in increasing survival.

The FDA has approved daprodustat (Jesduvroq – GSK), a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months. It is the first HIF-PHI and the first oral drug to be approved in the US for this indication.