Update on Drugs - February 2009

Ceftobiprole Zeftera®
Johnson & Johnson/ Basilea Pharmaceuticals

The US FDA rejected the New Drug Application for this antibiotic in November 2008. The FDA asked that additional audit work of clinical investigator sites be conducted and that specific questions related to site monitoring be addressed. This formulation has been approved in Canada and Switzerland to treat complicated skin and soft-tissue infections.

IV Iclaprim
Arpida Ltd.

The Therapeutic Products Directorate of Health Canada received, in September 2008, a New Drug Submission for this hospital antibiotic drug candidate for the treatment of complicated skin and skin structure infections. This dihydrofolate reductase inbitor has potent bactericidal activity against MRSA and an extended range of pathogens.

HPV Vaccine
Gardasil®
Merck & Co.

The US FDA approved additional indications for this HPV vaccine in September 2008 to include the prevention of vaginal and vulvar cancer caused by HPV types 16 and 18 in girls and women aged 9 to 26 years. The vaccine’s label has been revised to note that presently available information is insufficient to support use beyond age 26.

Alitretinoin
Toctino®
Basilea Pharmaceuticals

Atazanavir sulfate
REYATAZ®
Bristol-Myers Squibb

In October 2008, Genentech issued a Dear Healthcare Provider letter to inform potential prescribers of a case of progressive multifocal leukoencephalopathy (PML) in a 70-year old patient who had received Raptiva^® (efalizumab) for more than 4 years for treatment of chronic plaque psoriasis. The case was recently reported to the company in late September as part of Genentech’s ongoing safety monitoring and surveillance program. There are no other cases of confirmed PML in patients treated with this humanized therapeutic antibody, which is approved by the US FDA for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years of age or older who are candidates for systemic therapy or phototherapy. The company will work with the US FDA to update the prescribing information for Raptiva^® and determine if further action is needed. The Dear Healthcare Provider letter has been posted to the Genentech web site along with the current package insert that includes Raptiva^® safety information and is available by clicking the Raptiva^® link at http://www.gene.com/gene/products.

The US FDA notified healthcare professionals in November 2008 that it is investigating new preliminary data regarding a potential increase in the risk of serious skin reactions, incoluding Stevens-Johnson syndrome and toxic epidermal necrolysis from phenytoin therapy in Asian patients who are positivie for the human leukocyte antigen allele HLA-B*1502. This allele occurs almost exclusively in Asian patients with ancestry from areas such as China, the Philipines, Malaysia, India, and Thailand. This concern also applies to fosphenytoin because it is a prodrug that is converted to phenytoin after administration. Because this new data suggests a possible association between HLA-B*1502 and phenytoin or fosphenytoininduced SJS/TEN, and because of the known association between phenytoin and SJS/TEN, healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.