An automatic, noninvasive, glucose-monitoring device (GlucoWatch Biographer) has been approved for marketing by the FDA. The manufacturer states that it is not meant to replace a regular blood glucose meter.

Azelaic acid 15% gel (Finacea Berlex) is now available in the US for treatment of mild to moderate rosacea. A 20% cream formulation of the drug (Azelex Allergan; Medical Letter 1996; 38:52) has been marketed here since 1996 for treatment of acne. The effectiveness of Finacea compared to its own vehicle and to metronidazole gel is discussed. Information on the drug's mechanism of action, adverse effects, dosage and cost are also included.

Our May 24, 2004 article on use of the immune response modulator imiquimod (Aldara) for treatment of actinic keratoses stated that no systemic effects have been detected. A physician reader objected, stating that he had developed fatigue while using the cream and had heard from dermatologists that other patients had also reported systemic effects.

At a US Senate hearing prompted by the withdrawal of Vioxx, an FDA officer cited 5 drugs as potentially dangerous. It may be useful to revisit Medical Letter reviews of these drugs.

Sevelamer carbonate (Renvela – Genzyme), a buffered form of the anion-exchange resin sevelamer hydrochloride (Renagel – Genzyme),1 has been approved by the FDA for use in patients with chronic kidney disease on dialysis. According to the manufacturer, Renvela will replace Renagel, which has been shown to induce or exacerbate metabolic acidosis in patients on dialysis. Two randomized, crossover studies found the two sevelamer salts equivalent in their ability to lower serum phosphate.2,3 Patients taking the carbonate had higher serum bicarbonate concentrations and fewer gastrointestinal...

The drug of choice for patients who require parenteral treatment for malaria is IV artesunate, which is available now from the CDC Malaria Branch (M-F, 8 AM-4:30 PM eastern time, 770-488-7788 or, after hours, 770-488-7100). Artesunate appears to be more effective than quinine1 and safer than quinidine, the other parenteral alternatives in the US. The CDC has supplies of artesunate in Atlanta and in 8 quarantine stations in major airports around the US. It will release the drug for appropriate patients (severe disease or unable to take oral drugs) if it can be supplied as quickly as quinidine,...

The goal for drug therapy of type 2 diabetes is achieving and maintaining a near-normal glycated hemoglobin (HbA1C) concentration without inducing hypoglycemia; the target has generally been an HbA1C of 6.5-7.0% or lower. Whether treating to this level prevents macrovascular (cardiovascular) events has been unclear. Now, 2 large randomized, double-blind trials in patients with long-standing diabetes and at high risk for cardiovascular disease have found no decrease in macrovascular events with intensive glucose control.The ACCORD trial in about 10,000 patients found that patients intensively...

In 2007, Merck voluntarily recalled some lots of PedvaxHIB and Comvax, two Haemophilus influenzae type b (Hib) vaccines, and temporarily stopped their production because of possible contamination, resulting in a shortage during which pediatricians were urged to defer giving Hib booster doses (normally given at 12-15 months) to healthy children. Now the FDA has granted accelerated licensure of Hiberix (GlaxoSmithKline), a monovalent vaccine conjugated with tetanus toxoid that has been used in Europe since 1996, as a booster (final) dose of the Hib series in children 15 months-4 years old....

The FDA has granted regular approval to the oral kinase inhibitor tepotinib (Tepmetko – EMD Serono) for treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases and are associated with advanced disease and a poor prognosis. Tepotinib received accelerated approval for the same indication in 2021 based on initial overall response rates and duration of response.

Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic cervical cancer that progressed on or after chemotherapy. It is the first antibody-drug conjugate to be approved for treatment of cervical cancer. The drug received accelerated approval from the FDA in 2021 for the same indication.