October 04, 2005 Volume 41 Issue 33

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ALERTS

By Terry Murray
http://tinyurl.com/dlpe5

NEW SAFETY information has been issued recently for the following drugs:

Natalizumab (Tysabri)

Trials of natalizumab, a drug that had looked hopeful in the treatment of multiple sclerosis (MS), were stopped earlier this year because of several cases of progressive multifocal leukoencephalopathy, at least one of which was fatal (see the Medical Post, March 22, 2005.)

But last month, Biogen Idec. and Elan Corporation announced their safety evaluation of the drug in Crohn's disease and rheumatoid arthritis would be completed "in the coming weeks," and they planned to seek U.S. regulatory approval to resume study of the drug for Crohn's disease and rheumatoid arthritis.

For more information, see a joint press release from the two companies using the quick link tinyurl.com/7tsrr.

Long-acting beta-2 agonist bronchodilators

Product monographs for several long-acting beta-2 agonist bronchodilators (salmeterol and formoterol) have been revised as a result of a meeting in July of the U.S. Food and Drug Administration (FDA) pulmonary-allergy drugs advisory committee.

The FDA group considered the findings of the Salmeterol Multi-Centre Asthma Research Trial (SMART), in which there was an increased risk of asthma-related death and other serious respiratory-related outcomes in patients who used beta-2 agonists in addition to their usual asthma therapy.

Monographs have been revised for GlaxoSmithKline's salmeterol products (Serevent and Advair products), Novartis's formoterol (Foradil) and AstraZeneca's formoterol (Oxeze). For more information, go on-line and use the quick links tinyurl.com/8dbbb, tinyurl.com/dyhf8 and tinyurl.com/9d5j8.

Transdermal fentanyl (Duragesic)

Janssen-Ortho has revised the product monograph for Duragesic to reflect the serious, life-threatening and sometimes fatal hypoventilation that can result from overdose with transdermal fentanyl. The revision, made in consultation with Health Canada, follows a similar warning from the FDA (see the Medical Post, Aug. 9, 2005). For more information, use the quick online link tinyurl.com/8o9dw.

COX-2 inibitor (Celebrex)

New safety information for Celebrex has been incorporated into the drug's monograph by Pfizer Canada, based on ongoing scientific review of COX-2 inhibitors by Health Canada and other agencies. The monograph addition includes the acknowledgement that the drugs are associated with an increased risk of cardiovascular events and recommends the drug be used at the lowest effective dose for the shortest possible length of time. It also lists new contraindications including the peri-operative setting of coronary artery bypass graft surgery, pregnancy and breastfeeding, and cautions use of Celebrex in patients with ischemic heart disease, cerebrovascular disease and/or congestive heart failure, and those with risk factor for vascular or renal disease. For more information, use the quick link tinyurl.com/cpdzz.

Cetuximab (Erbitux)

New prescribing information has been added for cetuximab (Erbitux), indicated for the treatment of epidermal growth factor receptor-expressing metastatic colorectal cancer. ImClone Systems, Bristol-Myers Squibb and the FDA are now recommending an observation period of at least one hour following infusion of the drug, and electrolyte monitoring because of an increased incidence of hypomagnesemia. For more information, use the quick link tinyurl.com/ck4u4.

http://www.medicalpost.com/mpcontent/article.jsp?content=20051002_130531_4216