A biodegradable polymer 'wafer' (Gliadel - Rh ne-Poulenc Rorer) impregnated with the alkylating agent carmustine (BCNU; Bicnu) has been marketed in the USA for local treatment of recurrent glioblastoma multiforme that requires re-operation. The dime-sized polyanhydride wafers are implanted into the surgical cavity left behind after resection. Release of the alkylating agent directly into the area of the tumor bypasses the blood-brain barrier (H Brem and R Langer, Sci Med, 3:1, 1996).

The US Public Health Service Advisory Committee on Immunization Practices has recently published new recommendations for prevention and control of meningococcal disease in college students.

The FDA has approved the use of a transcatheter mitral valve device (MitraClip – Abbott) for percutaneous treatment of significant symptomatic degenerative mitral regurgitation (grade 3-4+) in patients who are at prohibitive risk for mitral valve surgery. It is the first percutaneous nonsurgical treatment approved for this indication.

The FDA has approved an inhalation solution formulation of the long-acting antimuscarinic agent (LAMA) glycopyrrolate (Lonhala Magnair – Sunovion) for maintenance treatment of chronic obstructive pulmonary disease (COPD). The new formulation is delivered using a portable, handheld, electronic nebulizer. Glycopyrrolate is also available as a dry powder inhaler, both alone (Seebri Neohaler) and in combination with indacaterol (Utibron Neohaler), and as a metered-dose inhaler in combination with formoterol (Bevespi Aerosphere). Lonhala Magnair is the first nebulized LAMA to become...

Since the last Medical Letter article on surgical correction of refractive errors (Volume 41, page 122, 1999), some new techniques have been tried and new results have been reported.

Panitumumab (Vectibix - Amgen), a fully human IgG₂ monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), has been approved by the FDA for treatment of patients with EGFR-expressing metastatic colorectal cancer that has progressed despite standard chemotherapy. It is the second monoclonal antibody EGFR inhibitor to be approved for metastatic colorectal cancer; cetuximab (Erbitux), a human-murine chimeric IgG₁ monoclonal antibody, was approved in 2004.

The FDA has approved ThermaClear (Therative), a battery-powered, handheld device, to treat individual acne lesions with heat. ThermaClear is indicated only for use on mild to moderate inflammatory acne, not severe nodular or severe cystic acne, and it is not meant to be used on blackheads and whiteheads. Two similar devices are already on the market: Zeno, another handheld device that delivers heat to acne lesions, and the Radiancy Clear Touch Lite Acne Clearance System, a larger heat-delivery device.

The American Heart Association has issued its revised guidelines for prevention of infective endocarditis. Antimicrobial prophylaxis for dental procedures is now recommended only for patients at the highest risk of severe consequences from endocarditis who are undergoing the highest-risk procedures. Endocarditis prophylaxis is no longer recommended for gastrointestinal (GI) and genitourinary (GU) procedures. When these changes are implemented, the number of patients receiving antimicrobial prophylaxis to prevent endocarditis should decline sharply.

Olodaterol (Striverdi Respimat – Boehringer Ingelheim), a new inhaled long-acting beta2-agonist, has been approved by the FDA for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Olodaterol is the third long-acting beta2-agonist to be approved by the FDA for once-daily use; indacaterol (Arcapta Neohaler), which is available as a single agent, and vilanterol, which is available only in fixed-dose combinations with the...

Since 2008, because of safety concerns, the FDA has mandated that long-term cardiovascular outcomes trials be conducted for all new drugs for type 2 diabetes. Reductions in the incidence of macrovascular complications in these trials with some sodium-glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients at risk for cardiovascular disease (see Table 1) have led to new recommendations.