An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational use (at Princeton University only) of a meningococcus B vaccine (4CMenB; Bexsero – Novartis) that has not been approved in the US. Bexsero has been approved for use in the European Union and in Australia.THE VACCINE — Until recently, no serogroup B vaccine was widely available because the polysaccharide capsule of the B serogroup, unlike those of the other main meningococcal serogroups (A, C, Y, and...

The FDA has approved Duopa (Abbvie), a carbidopa/levodopa enteral suspension, for treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). It has been available in Europe since 2001.In patients with advanced PD, emptying of the stomach may be delayed and unpredictable, which can affect the rate and amount of absorption of carbidopa/levodopa and its efficacy. To bypass the stomach, the new formulation is delivered through a nasojejunal (NJ) tube or percutaneous endoscopic gastrostomy with jejunal (PEG-J) tube.A randomized, double-blind, active-controlled, 12-week...

The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of migraine in adults. Now the FDA has added a new warning to its labeling about a risk of new-onset hypertension and worsening of preexisting hypertension associated with use of the drug. CGRP is a potent microvascular vasodilator; blocking or deleting it has produced hypertensive effects in animals.

The FDA has approved a 1.5% topical cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) for short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients ≥12 years old whose disease has not been adequately controlled with other topical prescription drugs. Ruxolitinib is the first JAK inhibitor to be approved for topical use and the first to be approved in the US for treatment of AD. An oral formulation of ruxolitinib (Jakafi) is approved for treatment of myelofibrosis, polycythemia...

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.

Recent reports have suggested that some obese patients may benefit from long-term pharmacologic treatment (RL Atkinson and VS Hubbard, Am J Clin Nutr, 60:153, August 1994; DJ Goldstein and JH Potvin, Am J Clin Nutr, 60:647, November 1994). Fluoxetine (Prozac), widely used for treatment of depression and near approval by the US Food and Drug Administration (FDA) for treatment of bulimia, is also being tried for treatment of obesity.

Botulinum toxin type A (Botox Cosmetic - Allergan) has received formal approval from the FDA for treatment of glabellar ("frown") lines in adults not more than 65 years old, and is being heavily advertised. Even before this approval, cosmetic use of botulinum toxin to reduce wrinkles on the face and neck had become a popular alternative to cosmetic surgery (Medical Letter 1999; 41:63). Botulinum toxin type A (Botox) and type B (Myobloc) are approved for treatment of cervical dystonia (Medical Letter 2001; 43:53), and type A has been approved since 1989 for treatment of strabismus and...

Daptomycin (Cubicin - Cubist), a cyclic lipopeptide (a new class of antibiotics), has been approved by the FDA for intravenous (IV) treatment of complicated skin and skin structure infections. It is being promoted as a once-daily bactericidal alternative to vancomycin (Vancocin, and others) for methicillin-resistant Staphylococcus aureusinfections.

Venlafaxine (Effexor, Effexor XR - Wyeth), an antidepressant that inhibits both norepinephrine and serotonin reuptake, was first approved by the FDA in 1993. It has been used mainly as a second-line agent for patients who have not responded to a selective serotonin reuptake inhibitor (SSRI). Some Medical Letter consultants have had the clinical impression that venlafaxine is more effective than an SSRI, particularly for patients with severe, classic depression (melancholia), and believe it should be considered a first-line drug (Treatment Guidelines from the Medical Letter 2003, 1:69). Is...

The FDA has approved pegaptanib sodium (Macugen - Pfizer/Eyetech) as an intravitreous injection for treatment of all subtypes of neovascular (wet) age-related macular degeneration (AMD). The only other approved treatment for this condition is photodynamic therapy with intravenous verteporfin (Visudyne), which is recommended only for patients with one subtype (predominantly classic) of neovascular AMD.