|Class||Name/Company||Approval Dates and Comments|
The US FDA issued an approvable letter in August 2002, for treating women with systemic lupus erythematosus (SLE). A Genelabs study demonstrated a positive effect on bone mineral density in women with mild-to-moderate SLE who were taking low does glucocorticoids. Approval is contingent on the successful completion of an additional clinical trial confirming this positive effect.
The US FDA approved a supplemental new drug application in September 2002, for the treatment of cold sores in healthy adults. It is the first one-day, oral antiviral medication shown to shorten the duration of a cold sore outbreak.
TPP Canada approved this transdermal product in August 2002, for birth control. This contraceptive patch is applied once/week and the first one to be approved by Health Canada.
Pharmacia has issued a “Dear Health Care Professional” letter recommending that valdecoxib (Bextra®) not be given to any patient with a previous allergic reaction to sulfonamides, and that it should be stopped at the first sign of a skin rash or hypersensitivity reaction. This nonsteroidal antiinflammatory agent (NSAID) was recently linked to a risk of hypersensitivity reactions (i.e., anaphylaxis, angioedema) and potentially severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme. Furthermore, some of the more life-threatening reactions occurred in patients with a history of allergic reactions to sulfonamides.
Allergan has entered into a research collaboration and license agreement for the right to develop and commercialize PEP005, a topical treatment for non-melanoma skin cancer and actinic keratosis from Peplin Biotech, a biomedical research company based in Brisbane, Australia. This product has shown early promise in pre-clinical studies and in a small open-label human proof of principle clinical study for the treatment of a wide range of human cancers, including melanoma and other skin cancers. Allergan will have exclusive license to develop and market this product for the topical and intralesional treatment of skin and eye conditions in North and South America.
The Institute for Safe Medication Practices recently reported cases of accidental daily administration of oral methotrexate where weekly dosing was intended. Some cases have resulted in fatalities. They state that because of the number of fatalities from errors, clinicians should consider it a high alert medication.