|Class||Name/Company||Approval Dates and Comments|
The United States FDA approved the addition of pediatric indications, including topical treatment of impetigo.
Hoechst Marion Roussel
Approved by Japanese drug regulatory authority for treatment of severe acne. Rulid was first launched in 1991, and has numerous other indications.
The United States FDA designated priority review in March, 1999, to this photodynamic therapy for the palliative treatment of recurrent, refractory or second primary squamous cell carcinomas of the head and neck in patients considered to be incurable with surgery or radiotherapy. Scotia hopes to file an NDA for this product by the end of September, 1999.
HPB Ottawa approved for the treatment of atopic dermatitis in infants three months of age or older.
The United States FDA has approved this vaginal tablet insert for treatment of atrophic vaginitis. There are a number of contraindications, including known/suspected breast carcinoma, estrogen-dependent neoplasia, pregnancy, abnormal genital bleeding, porphyria, thrombophlebitis or thromboembolic disorders, and hypersensitivity to VAGIFEM constituents.
The United States FDA approved this antifungal agent in March, 1999, for treatment of histoplasmosis, blastomycosis, and refractory aspergillosis, including use in immunocompromised patients. Contraindications include use with specific other drugs, such as Propulsid (cisapride), Halcion (triazolam), Versed (midazolam), Mevacor (lovastatin) or Zocor (simvastatin).
Johnson & Johnson/McNeil
The European Commission approved this wound healing agent in April, 1999, for the treatment of full thickness neuropathic, chronic diabetic ulcers.
The United States FDA approved the additional indication of use in pediatric patients.
Herbs and Anesthesia
The American Society of Anesthesiologists (JAMA 1999; 281:1882) is advising that the use of herbal products be discontinued for ≥ 2 weeks before surgery. Anesthesiologists have reported substantial changes in heart rate or blood pressure in some patients who were taking herbals such as St. John’s wort, gingko biloba and ginseng.
Deaths Related to Liposuction
A study in the New Engl J Med (1999;340:1471-75) suggests that tumescent liposuction can be fatal, possibly due to lidocaine toxicity or lidocaine related drug interactions. A total of 48,527 deaths were investigated, and of those, 5 occurred during or after liposuction. In this procedure, lidocaine doses can range from 10-88 mg/kg, much higher than the maximum recommended dose of 4.5mg/kg typically used for SC infiltration.