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Bayer Schering Pharma AG and Genzyme Europe BV have informed Healthcare Professionals on six infection-related deaths, reported from a trial ( CALGB10101 ) in which previously untreated, symptomatic ...


Cephalon informed Healthcare Professionals of the following new warnings and safety information for Provigil ( Modafinil ) regarding serious skin rash and psychiatric symptoms which have been provided ...


In agreement with the EMEA, F.Hoffmann-La Roche informed Health Care Professionals of new safety information regarding CellCept ( Mycophenolate mofetil ). • Isolated cases of progressive multifoca ...


The FDA ( Food and Drug Administration ) has received information regarding a study that was performed to investigate the possibility of an increased risk of cancer in patients with diabetes who appl ...


The FDA ( Food and Drug Administration ) has been made aware of recent findings from analyses of data collected from " The Data Collection on Adverse Events of Anti-HIV Drugs ( D:A:D ) Study ". The ...


The FDA ( Food and Drug Adminsitration ) is investigating a possible association between the use of Singulair ( Montelukast ) and behavior/mood changes, suicidality ( suicidal thinking and behavior ) ...


GlaxoSmithKline has informed Healthcare Professionals of a recent update to the Relenza ( Xanamivir ) Inhalation Powder package insert. The revision to the product label is a result of information a ...


The Exubera label has been updated by Pfizer and FDA ( Food and Drug Administration ). The update resulted from Pfizer and FDA ’s safety reporting and review processes related to clinical trials pro ...


The FDA ( Food and Drug Administration ) has approved Amitiza ( Lubiprostone ) for the treatment of irritable bowel syndrome with constipation ( IBS-C ) in adult women aged 18 and over. There is cur ...


The FDA ( Food and Drug Administration ) has approved Relistor ( Methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a c ...


The FDA ( Food and Drug Administration ) has approved a new drug for treating Crohn's disease. Cimzia ( Certolizumab pegol ) received approval for adults with moderate to severe Crohn's disease who ...


In Canada the use of intravenous immune globulin ( IVIG ) is reported to have increased by approximately 115% over the past 7-8 years, making Canada one of the highest per capita users of IVIG in the ...


Evra is a transdermal hormonal contraceptive system containing 6 mg of Norelgestromin and 0.6 mg of Ethinyl Estradiol per patch. Since its introduction on the Canadian market in early 2004, 16 cas ...


Topiramate ( Topamax ) is an antiepileptic indicated for either monotherapy or add-on therapy in adults and in children aged two years and over; and for the prophylaxis of migraine in adults. Topir ...


The FDA ( Food and Drug Administration ) has approved Entereg ( Alvimopan ) to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small ...


Aprotinin ( Trasylol ) is associated with a 50 per cent increase in the relative risk of death, according to a major Canadian clinical trial comparing three drugs routinely used to prevent blood loss ...


Access to Trasylol ( Aprotinin ) is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients ...


The FDA ( Food and Drug Administration ) has required manufacturers of conventional antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increas ...


Safety reviews of tumor necrosis factor-alpha ( TNF-a ) antagonists, Infliximab ( Remicade ), Etanercept ( Enbrel ), and Adalimumab ( Humira ) identified rare cases of serious skin reactions, includin ...


The FDA ( Food and drug Administration ) has informed healthcare professionals of the risk of adverse injection site reactions in patients receiving Naltrexone ( Vivitrol ). Physicians should instr ...


Since October 2007, FDA ( Food and Drug Administration ) has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta ( Exenatide ). Byetta is a medicine giv ...


The FDA ( Food and Drug Administration ) has approved Xenazine ( Tetrabenazine ) for the treatment of chorea in people with Huntington’s disease. Chorea is the jerky, involuntary movement that occur ...


The FDA ( Food and Drug Administration ) is investigating a report from the SEAS trial ( Simvastatin and Ezetimibe in Aortic Stenosis ) of a possible association between the use of Vytorin ( a combina ...


Duloxetine ( Cymbalta ) is a serotonin and norepinephrine reuptake inhibitor ( SNRI ) for oral administration initially approved in August 2004 to treat major depressive disorder. Subsequently, FDA ap ...


The FDA ( Food and Drug Administration ) and Cephalon notified healthcare professionals of updates to the Warnings section of the prescribing information for Provigil ( Modafinil ). Provigil is indi ...


The FDA ( Food and Drug Administration ) has approved Ixempra ( Ixabepilone ), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer who have not responded ...


The FDA ( Food and Drug Administration ) has approved Tasigna ( Nilotinib ) capsules for treatment of Philadelphia chromosome positive chronic myeloid leukemia ( CML ) in adult patients whose disease ...


Thiazolidinediones include Rosiglitazone ( Avandia and Avandamet ) and Pioglitazone ( Actos ). These medicines act to increase insulin sensitivity and are widely prescribed to treat type II diabetes m ...


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 ...


Patients given Rimonabant are at increased risk of severe psychiatric events. The prevalence of obesity continues to increase worldwide, and there is a demand for effective and safe anti-obesity ag ...


Patients taking anti-obesity drugs will only see modest weight loss and many will remain significantly obese or overweight. The study, which looked at the long-term effectiveness of anti-obesity me ...


The FDA ( Food and Drug Administration ) has approved Crestor ( Rosuvastatin ) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. The submissio ...


The FDA ( Food and Drug Administration ) issued its second safety warning about the Fentanyl transdermal system ( Duragesic ), an adhesive patch that delivers a potent pain medicine through the skin. ...


The FDA ( Food and Drug Administration ) has approved Kuvan ( Sapropterin ), the first drug of its kind approved to slow the effects of a rare genetic disorder that causes mental retardation, smalle ...


The FDA ( Food and Drug Administration ) has required that manufacturers of over-the-counter ( OTC ) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient Nonox ...


Rimonabant ( Acomplia / Zimulti ) is a cannabinoid receptor antagonist. It acts by blocking a specific type of receptor called cannabinoid type 1 ( CB1 ) receptors. These receptors are found in the ne ...


Recombinant human erythropoietins ( r-HuEPOs ) are indicated for the treatment of anaemia in patients with chronic kidney disease. Some r-HuEPOs are also authorised for the treatment of patients with ...


Rosiglitazone (Avandia, Avandamet ) and Pioglitazone ( Actos, Competact ) are treatments for patients with type 2 diabetes and belong to a class of drugs called thiazolidinediones ( also called glita ...


Ace ( angiotensin converting enzyme ) inhibitors and sartans ( also called angiotensin II receptor antagonists ) are licensed for various indications, including hypertension, and may be particularly ...


Short-acting beta-agonists are indicated for reversible airway obstruction, or prevention of premature labour, or both. Short-acting beta-agonists are available as inhalation, oral, intravenous, or su ...


Gastrointestinal toxicity and cardiovascular toxicity are the two most important safety concerns for non-steroidal anti-inflammatory drugs ( NSAIDs ) and COX-2 inhibitors ( coxibs ). Clinical trial ...


Varenicline ( Champix ) is an aid to smoking cessation; it was launched in the United Kingdom ( UK ) in December, 2006. Varenicline is a partial agonist at the nicotinic alpha4beta2 receptor. 15 ...


Most of the cases of osteonecrosis of the jaw are seen in oncology patients that, besides intravenous bisphosphonates, have received chemotherapy in the long term for their base disease with or with ...


The FDA ( Food and Drug Administration ) is concerned that nursing infants may be at increased risk of Morphine overdose if their mothers are taking Codeine and are ultra-rapid metabolizers of Codeine ...


The FDA ( Food and Drug Administration ) announced manufacturers, GlaxoSmithKline ( GSK ) and Takeda, of glitazones approved to treat type 2 diabetes, have agreed to add a stronger warning on the risk ...


As of 10 August 2007, the TGA ( Therapeutic Goods Administration ), in Australia, had received eight reports of serious liver adverse reactions associated with use of Lumiracoxib ( Prexige ), includin ...


The Therapeutic Goods Administration ( TGA ) has cancelled the registration of the osteoarthritis drug, Lumiracoxib because of serious liver side effects associated with the use of the drug. Lumira ...


As of 10 August 2007, the TGA ( Therapeutic Goods Administration ) had received eight reports of serious liver adverse reactions associated with use of Lumiracoxib ( Prexige ), including two deaths an ...


Researchers at University of Manchester, UK, evaluated the risk of myocardial infarction associated with the use of selective cyclooxygenase-2 ( COX-2 ) inhibitors ( coxibs ). A systematic review ...


The purpose of the researchers at Université Victor Segalen, Bordeaux, France, has been to monitor the potential clinical neurotoxic symptoms in patients treated with Leflunomide ( Arava ) in daily p ...