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ABACAVIR Drug Information Page

Updated 08/09/2010 12:50:36 AM

ProductSourceDateLinkData
ABACAVIRMHRA2009-7-6ABACAVIR-MHRA-2009-7-6MHRA Safety Update. Clopidogrel and proton pump inhibitors: interaction Abacavir: risk of myocardial infarction - update from epidemiological studies Use of long-acting �-agonists in chronic obstructive pulmonary disease Mycophenolate mofetil: pure red cell aplasia Hydroxycut range of food supplements: risk of liver damage Priadel Liquid: potential for dosing errors Clarification: ACE inhibitors and angiotensin II receptor antagonists - use during breastfeeding
ABACAVIRFDA2008-7-24ABACAVIR-FDA-2008-7-24FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.
ABACAVIRFDA2008-6-24ABACAVIR-FDA-2008-6-24FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.
ABACAVIRHealth Canada2008-6-23ABACAVIR-Health Canada-2008-6-23GlaxoSmithKline, in consultation with Health Canada, would like to provide you with new safety information regarding a potential increased risk of myocardial infarction in HIV-infected patients treated with abacavir-containing medicinal products (ZIAGEN�, KIVEXA� and TRIZIVIR�). Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI) which is used in combination with other antiretrovirals in the treatment of human immune deficiency syndrome virus (HIV) infection.
ABACAVIRFDA2008-3-27ABACAVIR-FDA-2008-3-27The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA�(TM)s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking. This early communication is in keeping with FDA�(TM)s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
ABACAVIRFDA2007-4-10ABACAVIR-FDA-2007-4-10Two 60-count misbranded bottles of Combivir Tablets contained 300 mg tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009. The incident appears to be isolated and limited in scope to one pharmacy in California. Pharmacists should immediately examine the contents of each bottle of Combivir in their pharmacy to confirm that the bottles contain the correct medication.

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