Bedaquiline (bed ak' wi leen; Sirturo – Janssen), a diarylquinoline antimycobacterial, has been given accelerated approval by the FDA as an orphan drug for use in addition to other drugs for treatment of adults with multidrug-resistant pulmonary tuberculosis (MDR-TB). It is the first drug approved specifically to treat MDR-TB.

View Expanded Table: Some Conventional DMARDs for Rheumatoid Arthritis

The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.

Levodopa combined with carbidopa (Sinemet) is the treatment of choice for Parkinson's disease (Medical Letter, 30:113, 1988). After prolonged treatment, however, the symptoms of the disease often become difficult to manage. The benefit from each dose becomes shorter (the 'wearing-off' effect), sudden fluctuations occur between mobility and immobility (the 'on-off' phenomenon), and abnormal involuntary movements (dyskinesias) may become frequent. The dopamine agonist bromocriptine (Parlodel) can ameliorate some of these effects. Two new drugs, pergolide (Permax - Lilly), another dopamine...

Leflunomide (Arava - Hoechst Marion Roussel), which inhibits pyrimidine synthesis, and etanercept (Enbrel - Immunex/Wyeth-Ayerst), which blocks the action of tumor necrosis factor (TNF), have been approved by the FDA for treatment of rheumatoid arthritis. A third drug, infliximab (Remicade - Centocor), which also blocks TNF and has been used to treat rheumatoid arthritis, was approved earlier for treatment of Crohn's disease. Its use in Crohn's disease will be reviewed in a future issue.

FluMist (MedImmune), the first live-attenuated and first intranasally administered influenza vaccine, has been approved by the FDA to prevent influenza in healthy people 5-49 years old. Given as a nasal spray, it stimulates immunity by viral replication in the upper respiratory tract. This vaccine apparently will be advertised directly to the public as a "needle-free" alternative to intramuscular influenza vaccine.

Vytorin, a fixed-dose combination of the cholesterol absorption inhibitor ezetimibe (Zetia - Merck/Schering Plough) and the HMG-CoA reductase inhibitor ("statin") simvastatin (Zocor - Merck), has been approved by the FDA for treatment of hypercholesterolemia. It is available as tablets containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of simvastatin.

Recent publicity about symptoms of ovarian cancer will prompt many questions from patients about testing for the disease. Early-stage epithelial ovarian cancer is potentially curable, with survival rates of 90-95%, but about 75% of women have advanced or metastatic disease at diagnosis. Between physical examination and exploratory surgery, 2 tests are commonly used.1Transvaginal ultrasound (TVUS) images the ovaries better than transabdominal ultrasound. In a study in which 25,327 asymptomatic women were screened with TVUS annually from 1987 to 2005, 364 patients had exploratory surgery, and 44...

Fluvoxamine maleate, a selective serotonin reuptake inhibitor (SSRI) that has been available for many years in an immediate-release formulation (Luvox, and others) for treatment of obsessive-compulsive disorder (OCD) in children and adults, has now been approved by the FDA in an extended-release formulation (Luvox CR - Jazz Pharmaceuticals) for treatment of OCD and social anxiety disorder (SAD) in adults.

The US Preventive Services Task Force (USPSTF) has recently concluded that available evidence is insufficient to assess the balance between potential benefits and harms of using the prostate-specific antigen (PSA) to screen men < 75 years old for prostate cancer and has recommended against screening men > 75 years old.