A reader commenting on our Treatment of Lyme Disease article (Med Lett Drugs Ther 2016; 58:57) objected to a footnote in the table advising against use of doxycycline in children <8 years old. This warning has been included in the labeling of all tetracyclines since 1970 when it was recognized, after decades of use, that these drugs caused permanent staining and enamel hypoplasia of developing teeth. The CDC recently stated that short courses of doxycycline, which was first marketed in the US in 1967 and has less affnity for calcium than other tetracyclines, have not been shown to cause...

Essure (Bayer) is the only nonsurgical, permanent contraceptive available in the US. The coil-like devices are placed hysteroscopically in both fallopian tubes and, after several months, scar tissue causes tubal occlusion.1 In 2016, the FDA required Bayer to revise the device's labeling to include a patient decision checklist and a boxed warning about the risks of uterine and fallopian tube perforation, migration of the device to the abdominal or pelvic cavity, persistent pain, and hypersensitivity reactions. Some women were apparently not being informed of these risks before implantation of...

Telithromycin (Ketek - Aventis) has been approved by the FDA for oral treatment of mild to moderate community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute bacterial sinusitis in patients age 18 and older. The drug is the first in a new class of antibiotics, the ketolides, derived from the macrolide erythromycin. Telithromycin has been marketed in Europe since 2001.

Photopheresis is a new technique recently approved by the US Food and Drug Administration for treatment of cutaneous T-cell lymphoma. It combines oral administration of a photoactivatable cytotoxic drug with leukapheresis and extracorporeal exposure of leukocytes to long-wave ultraviolet light (UVA). This procedure requires use of a 'UVAR Instrument' manufactured by Therakos, a subdivision of Johnson and Johnson.

Vinorelbine (Navelbine - Burroughs Wellcome), a semisynthetic vinca alkaloid, has been approved by the US Food and Drug Administration for parenteral use in the treatment of advanced non-small-cell lung cancer (NSCLC). Various combinations of cisplatin (Platinol), vinblastine (Velban, and others), mitomycin (Mutamycin), ifosfamide (Ifex), etoposide (VePesid) and paclitaxel (Taxol) have been used previously for this indication.

Anagrelide (an ag' gre lide) hydrochloride (Agrylin - Roberts), a quinazolin derivative, has been approved by the FDA for oral treatment of essential thrombocythemia. Patients with this uncommon myeloproliferative disorder have an increased number of circulating platelets and are at risk for both thrombosis and hemorrhage.

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 FDA has asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) antidepressant citalopram (Celexa, and others) to revise the labeling of the drug to include new warnings about the risk of QT interval prolongation.

The FDA has approved the oral tyrosine kinase inhibitor cabozantinib (Cabometyx – Exelixis) for treatment of patients with advanced renal cell carcinoma previously treated with antiangiogenic therapy. Cabozantinib was first approved in 2012 as Cometriq for treatment of progressive, metastatic medullary thyroid cancer.Anti-VEGF antibodies, tyrosine kinase inhibitors, and mTOR kinase inhibitors have become the standard of care for treatment of unresectable or metastatic renal cell cancer.1FDA approval was based on the results of a randomized open-label trial (METEOR) comparing cabozantinib to...

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...