Thalidomide (Thalomid - Celgene), a synthetic derivative of glutamic acid, has been approved by the FDA for use in treatment of leprosy. Thalidomide was marketed in Europe in 1957 as a sedative but withdrawn four years later after being associated with severe human teratogenicity. The drug has since been found to be effective for several different indications.

Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with previously untreated chronic lymphocytic leukemia (CLL). Two other anti-CD20 antibodies, rituximab (Rituxan) and ofatumumab (Arzerra), were previously approved for treatment of CLL.

The FDA has approved a new formulation of glucagon (Gvoke – Xeris) for subcutaneous treatment of severe hypoglycemia in patients ≥2 years old with diabetes. Conscious patients with symptoms of hypoglycemia can take oral glucose. Glucagon is usually administered by a caregiver to an unresponsive patient. The new formulation is available in a single-use prefilled syringe (Gvoke PFS) and is expected to become available in a single-use auto-injector (Gvoke HypoPen) in 2020. Unlike previously available injectable glucagon products (Glucagon Emergency Kit, and others), Gvoke does not...

The FDA has approved the oral tyrosine kinase inhibitor avapritinib (Ayvakit – Blueprint Medicines) for treatment of unresectable or metastatic gastrointestinal stromal tumors (GISTs) harboring a platelet-derived growth factor receptor alpha (PDGFRA) D842V or other PDGFRA exon 18 mutation. Avapritinib is the first drug to be approved for this indication in the US.

The FDA has approved lacosamide (Vimpat - UCB Pharma) for oral or intravenous (IV) use as add-on therapy in adults with partial-onset seizures.

Almost 300,000 cases of epidemic cholera have occurred in the Western Hemisphere in 1991, mostly in South and Central America (Morbid Mortal Weekly Rep, 40:562, Aug 16, 1991). The few US cases caused by the epidemic strain have been in returning travelers or associated with contaminated food they brought back illicitly, with no secondary spread to date.

Sertraline (Zoloft - Roerig), a serotonin reuptake inhibitor, was recently approved for marketing by the US Food and Drug Administration for treatment of depression. Another serotonin reuptake inhibitor, fluoxetine (Prozac), is prescribed more frequently in the USA than any other antidepressant (Medical Letter, 32:83, 1990).

Docetaxel (Taxotere - Rh ne-Poulenc Rorer), a semisynthetic taxoid similar to paclitaxel (Taxol - Medical Letter, 35:39, 1993), has been approved by the US Food and Drug Administration for use in locally advanced or metastatic breast cancer that has progressed or relapsed during treatment that included an anthracycline such as doxorubicin (Adriamycin, and others).

The FDA had approved an intrauterine contraceptive device that releases the synthetic progestin levonorgestrel over a period of five years. The device has been available in Europe for 10 years.

The FDA has added a "black box" warning about the risks of QT prolongation and the potentially fatal torsades de pointes (TdP) ventricular tachycardia to the labeling of droperidol (Inapsine - Akorn), an antiemetic used mostly in anesthesia. The Canadian Health Protection Branch has issued a similar warning. Some anesthesiologists have written to The Medical Letter to express their displeasure with these warnings.