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Meta
Monthly Archives: December 2004
EMEA press release on review of Cox-2 inhibitors
The EMEA is accelerating its review into the safety of Cox-2 inhibitors, and will present them at the CHMP meeting fron 17th-20th January 2005. Press release
Posted in EMEA
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Interaction between atazanavir/ritonavir and omeprazole
The EMEA report new pharmacokinetic data showing that atazanavir when combined with ritonavir has an interaction with omeprazole 40mg resulting in a 76% reduction in atazanavir AUC and 78% reduction in Cmin. EMEA public statement
Posted in EMEA, Interactions
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Updated safety information on disodium pamidronate and zoledronic acid
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
Posted in ADRs, Health Canada
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Atomoxetine (Strattera) and liver disease
The FDA announce a labelling change for Stattera (atomoxetine) listing the potential for severe liver disease following 2 reports in children. FDA talk paper
Naproxen and cardiovascular events
The FDA announce the decision to stop a trial of NSAIDs in patients at risk of Alzheimer’s disease in the US. Preliminary results show a greater risk of cardiovascular events in patients treated with naproxen over placebo. Note that naproxen … Continue reading
Posted in FDA
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MHRA warns of illegal importation of TCM containing aristolochia
The MHRA have seized a consignment of traditional Chinese medicine (TCM) which reportedly contains the toxic herb Aristolochia. They repeat their advice that all products containing Aristolochia are banned in the UK because of the potential for kidney failure MHRA … Continue reading
Posted in Herbal safety, MHRA
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Further advice on Cox-2 inhibitors from the MHRA
The MHRA advises patients not to be alarmed about the latest news of Cox-2 inhibitors but suggests that they make a non-urgent appointment with their GPs to have their treatment reviewed. Health professionals are advised that all patients with ischaemic … Continue reading
Posted in MHRA
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Our latest bulletin is published
Our Christmas edition of re:Action 31 has just been published (pdf). It contains articles on drug-induced hallucinations, drug-induced gambling addiction, isotretinoin and neuropathy, and moxifloxacin and bronchospasm, and a thank you to reporters for making 2004 one of our best … Continue reading
Posted in Publications
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Use of celecoxib to treat Familial Adenomatous Polyposis
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
Posted in Health Canada
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Cardiovascular safety of celecoxib (Celebrex)
Pfizer has released information from two long term trials of celecoxib in cancer patients. One of the trials showed an increased cardiovascular risk over placebo. Pfizer’s statement FDA statement MHRA statement EMEA’s press release ADRAC media statement