adr.org.uk » Health Canada

Canadians withdraw lumiracoxibâ–¼ (PrexigeÂ®)

admin — Fri, 12 Oct 2007 09:10:51 +0000

The NPCi blog documents the recent withdrawal of lumiracoxibâ–¼ (PrexigeÂ®) in Canada and argue that:

The concern about lumiracoxibâ€™sâ–¼ potential for rare but serious, even fatal liver reactions must feature in prescribing decisions about the drug, along with the increased risk of thrombotic events seen with all coxibs (note that all coxibs are now contraindicated for people with established ischaemic heart disease, cerebrovascular disease and peripheral artery disease, and individual risk assessment is appropriate for patients with risk factors for cardiovascular events)

AVASTINÂ® (bevacizumab) and tracheo-esophageal fistulas

admin — Fri, 29 Jun 2007 09:14:49 +0000

Health Canada and Hoffmann-La Roche Limited have issued a letter to health care professionals warning of the risk of tracheo-esophageal fistula associated with bevacizumab:

Serious adverse events, including fatal events, of tracheo-esophageal (TE) fistula have been reported in association with use of AVASTIN clinical trials of small cell lung cancer (SCLC), non small cell lung cancer (NSCLC) and esophageal cancer.

AVASTIN should be permanently discontinued in patients with tracheo-esophageal (TE) fistula or any gastrointestinal fistula. There is limited information on the continued use of AVASTIN in patients with other fistulas.

In cases of internal fistula not arising in the GI tract, discontinuation of AVASTIN should be considered.

Ezetrol (ezetimibe) – Canadian advisory

admin — Mon, 07 Feb 2005 13:45:06 +0000

The Canadian Therapeutic Products Directorate have posted about the association of Ezetrol (ezetimibe) with myalgia, rhabdomyolysis, hepatitis, pancreatitis, and thrombocytopenia.

Merck Frosst/Schering Pharmaceuticals briefing for patients.

Merck Frosst/Schering Pharmaceuticals briefing for professionals.

Latest Canadian ADR Bulletin published

admin — Fri, 07 Jan 2005 12:22:25 +0000

This edition contains articles on Telithromycin and warfarin, Linezolid and neuropathy, Camphor and eucalyptus oils, Natural weight loss product and myopathy, and olanzapine and pulmonary embolism

Updated safety information on disodium pamidronate and zoledronic acid

admin — Wed, 22 Dec 2004 08:38:32 +0000

Health Canada and Novartis have advised of reports of osteonecrosis of the jaw in cancer patients being treated with disodium pamidronate (Aredia) and zoledronic acid (Zometa).

Health Canada advisory
Dear Healthcare professional letter

Use of celecoxib to treat Familial Adenomatous Polyposis

admin — Sun, 19 Dec 2004 00:55:00 +0000

Health Canada advise of increased cardiovascular risks when celecoxib is taken at doses of 400mg and 800mg per day. They advise that celecoxib should not be taken for the prevention of recurrence of Familial Adenomatous Polyposis.

Health Canada advisory

Rosuvastatin (Crestor®)

admin — Fri, 03 Dec 2004 15:29:40 +0000

Health Canada have issued an advisory notice about rosuvastatin, following 6 cases of rhabdomyolysis being reported.

Health Canada wishes to advise Canadians of safety concerns about Crestor®, a cholesterol lowering drug, when used at the highest recommended dosage of 40 mg daily. The risk of rhabdomyolysis (muscle breakdown) may be increased at higher doses. Health Canada recommends that all patients taking CrestorÂ®, or any cholesterol lowering drug, should be using the lowest dose that will meet their treatment goal.

Pegolide and heart valve problems

admin — Thu, 28 Oct 2004 13:19:52 +0000

Sire BioChem Inc in association with Health Canada have issued a Dear Healthcare Professional letter warning of a greater risk of cardiac valvulopathy in patients being treated with pergolide for Parkinson’s disease.

Dear Healthcare Professional letter
Notice for Patients

Eprex (epoetin alfa) and thrombotic vascular events

admin — Wed, 20 Oct 2004 10:54:19 +0000

Janssen-Ortho and Health Canada warn of a possible association between Eprex and blood clots in patients with cancer treated to raise their level of red blood cells to higher than usual. Some of the clots proved fatal.

Dear Health Care Professional letter