|Name/Company||Approval Dates and Comments|
Dimethicone 50% topical solution
G. Pohl-Boskamp GmbH Pediapharm Inc.
Health Canada approved this new OTC pesticidefree pediculicide in September 2011 for the physical treatment of head lice infestation. The active ingredient, dimethicone, works by suffocating the lice, nymphs, and eggs. Due to its physical mode of action (interruption of the lice’s oxygen supply of the central nervous system) development of resistance appears unlikely.
Health Canada approved the marketing and distribution of this radiofrequency device in September 2011 for use in non-invasive body contouring, fat removal, wrinkle reduction, and skin tightening. It is the first focused radiofrequency technology in North America to receive approval for four aesthetic indications. This device has also received US FDA clearance for use in non-invasive dermatologic and aesthetic procedures with indications for non-invasive treatment of wrinkles and rhytids.
Skin barrier protectant
Neosalus® Lotion was launched in the US in November 2011 as a non-steroidal anti-inflammatory prescription product for the topical management of skin disorders, such as atopic dermatitis and allergic contact dermatitis. The key ingredients (dimethicone, glycerin, and stearic/ palmitic acids) are formulated for skin barrier repair, protection, and hydration, as well as restoration of ceramides, cholesterol, and other free fatty acids.
In October 2011, Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to recommend the routine use of the human papillomavirus (HPV) quadrivalent vaccine (Gardasil®) for boys aged 11 and 12 years. The ACIP also recommended vaccination for males aged 13 to 21 years who have not yet been immunized or have not completed the 3-dose series. Vaccinating males can confer protection from genital warts and HPV-related cancer, such as throat and anal cancers. This wider use of the vaccine may also prevent transmission of the HPV virus to females.
A recent article in the Canadian Medical Association Journal* reports that a commonly prescribed antimicrobial compound containing trimethoprim and sulfamethoxazole (e.g., Septra®, Bactrim®, and generics) can potentially cause serious adverse reactions and calls for physician vigilance when prescribing. The most common adverse effects found were rashes and fixed drug eruptions, drug-drug interactions, and hyperkalemia. Rashes and fixed drug eruptions occurred in about 3% of patients. Serious and/or lifethreatening adverse reactions (e.g., hyperkalemia, hypoglycaemia, and liver damage) have been reported and are usually the result of drug interactions.
*Ho JM, et al. Considerations when prescribing trimethoprim-sulfamethoxazole. CMAJ 2011 Nov 8; 183(16):1851-8.
In August 2011, the US FDA issued a Warning Letter citing Brazilian Blowout for safety and labeling violations. Formaldeyde, a known carcinogen, has been commonly found in a number of Brazilian style keratin-based hair straightening products tested. The letter lists health risks associated with inhaling formaldehyde when the product is used as directed. Reported adverse reactions include irritation/problems of the eyes and respiratory tract, headaches and dizziness, nausea, chest pain, vomiting, and rash. The letter also states that the labeling was misleading because the product is incorrectly labeled as “formaldehyde free” and neglects to warn of possible consequences from product usage under the conditions prescribed in the labeling.