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ODAC recommends against approving Tarceva for first-line maintenance use in advanced non-small cell lung cancer

OSI Pharmaceuticals and Genentech announced that FDA ( Food and Drug Administration ) Oncologic Drugs Advisory Committee ( ODAC ) voted 12 to one recommending against approval of Tarceva ( Erlotinib ) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer ( N...
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Hyponatraemia associated with drugs

TGA ( Therapeutic Goods Administration ) continues to receive reports of hyponatraemia in association with various medicines. Severe hyponatraemia is a potentially devastating condition that can develop rapidly and without obvious prior symptoms, particularly in the elderly. Since May 2005 we ...
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CYP3A4 inhibitors may increase potential for Colchicine toxicity

Colchicine is indicated for the treatment of acute gout, but it has a narrow therapeutic index with significant potential for toxicity and severe drug interactions. In mid-2007, the TGA required updates to the Colgout and Lengout product information to limit Colchicine usage to only where NSAID...
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Oral Terbinafine can be associated with rare but serious and life-threatening toxicities

Oral Terbinafine ( Lamisil ) is approved for the treatment of fungal infections of the nails and skin that are not responsive to topical therapy. ADRAC ( Adverse Drug Reactions Advisory Committee ) is concerned that in some cases the oral form of Terbinafine may be selected without any trial of t...
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Zolpidem and bizarre sleep related effects

Zolpidem ( Stilnox ) was marketed in Australia in late 2000 for the short term treatment of insomnia. It is structurally unrelated to the benzodiazepines, but has a similar pharmacological action. In 2002, ADRAC ( Adverse Drug Reactions Advisory Committee ) reviewed the first year of use and it ...
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Renal impairment associated with Zoledronic acid

There is a well-known risk of deterioration in renal function with intravenous bisphosphonates administered at a rapid infusion rate. ADRAC ( Adverse Drug Reactions Advisory Committee ) has received few reports of renal impairment or failure with Pamidronate ( Aredia ) and the oral bisphosphonates...
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TNF-alpha inhibitors are associated with several serious reactions

Tumour necrosis factor alpha ( TNF-alpha ) is a cellular protein produced by the immune system and is an important mediator of many diseases, including inflammatory arthritis and inflammatory bowel disease. Currently, three tumour necrosis factor alpha blocking agents are registered in Australia: ...
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Interstitial lung disease associated with Leflunomide

Leflunomide ( Arava ) is a disease-modifying anti-rheumatic drug ( DMARD ) for the treatment of rheumatoid arthritis, which has been available in Australia since 2000. A publication described 7 Australian and 7 New Zealand reports of pneumonitis in association with leflunomide. ADRAC ( Adverse ...
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Human papillomavirus vaccine safety: VAERS reports 6 months after approval of Gardasil

On June 8th 2006, the FDA ( Food and Drug Administration ) announced the approval of Gardasil, and on June 29th the Advisory Committee on Immunizations Practices ( ACIP ) voted to recommend adding Gardasil human papillomavirus vaccine to the Centers for Disease Control's national childhood recommend...
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Aripiprazole may cause neuroleptic malignant syndrome

ADRAC ( Adverse Drug Reactions Advisory Committee ) has previously noted that the two oldest of the atypical antipsychotics, Clozapine ( Clozaril ) and Olanzapine ( Zyprexa ), can cause neuroleptic malignant syndrome ( NMS ). Although it appears that, of the atypical antipsychotics, neuroleptic...
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