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Safety Update to the Prescribing Information for Diclofenac Products
The FDA has required revisions to the prescribing information for diclofenac to add new warnings about the potential for increases in liver enzymes during treatment. There have been post-marketing reports of cases of drug-induced liver toxicity reported in the first month of use of diclofenac. Increased liver enzymes can be an early sign of liver toxicity. The prescribing information is being updated for all products containing diclofenac, including capsules, gels, patches, solutions, and tablets. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used in the treatment of pain and inflammation caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Diclofenac is also used to treat painful menstrual periods and pain from other causes. Diclofenac is sold under the names Cambia, Cataflam, Flector Solaraze, Voltaren, Voltaren-XR, ZIpsor, and as a combination product called Arthrotec (containing diclofenac and misoprostol). For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm
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Safety Update to Prescribing Information for Lexiva (Fosamprenavir)
GlaxoSmithKline (GSK) and the FDA have announced a potential link between Lexiva (fosamprenavir) and heart attacks and hypercholesterolemia (high cholesterol and triglycerides) in HIV infected adults. GSK has updated the prescribing information for Lexiva to include this new safety information. Lexiva is used in the treatment of HIV-infection and belongs to the class of antiretroviral medicines called protease inhibitors. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm
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Date Published Title Drug Source
2009-12-08 Safety Update to the Prescribing Information for Diclofenac Products Diclofenac FDA
2009-12-03 Safety Update to Prescribing Information for Lexiva (Fosamprenavir) Fosamprenavir FDA
2009-12-03 Changes to the Warnings Sections of Norpramin (desipramine) Prescribing Information Desipramine FDA
2009-11-23 FDA Early Communication About Ongoing Safety Review of Sibutramine (Meridia) Sibutramine FDA
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Oxymetazoline FDA
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Phenylephrine FDA
2009-11-20 Recall on A Single Lot of OPANA ER (Oxymorphone) 10 mg Extended Release Tablets Oxymorphone FDA
2009-11-20 Recall of Single Lot of Advanced Listerine with Tartar Protection Listerine FDA
2009-11-20 Recall of a Single Lot of Ranbaxy Sotret (Isotretinoin) 40 mg Capsules Isotretinoin FDA
2009-11-20 Recall of a Single Lot of Teva / Ivax Oxazepam 15 mg Capsules Oxazepam FDA
2009-11-20 Recall of Several Lots of Brompheniramine Tannate Suspension Brompheniramine FDA
2009-11-20 Recall of a Single Lot of Brompheniramine Phenylephrine Tannate Suspension Brompheniramine with Phenylephrine FDA
2009-11-17 Updated Safety Information About A Drug Interaction Between Clopidogrel (Plavix) and Omeprazole (Prilosec, Prilosec OTC) Clopidogrel FDA
2009-11-14 Possible Contamination of Thyrogen Thyrotropin Alfa FDA
2009-11-14 Possible Contamination of Aldurazyme Laronidase FDA
2009-11-14 Possible Contamination of Myozyme Alglucosidase Alfa FDA
2009-11-14 Possible Contamination of Fabrazyme Agalsidase Beta FDA
2009-11-14 Possible Contamination of Cerezyme Imiglucerase FDA
2009-11-12 Recall on a Single Lot of Invega Extended Release 6 mg Tablets Paliperidone FDA
2009-11-12 Recall on a Single Lot of Temodar Capsules 5 mg Temozolomide FDA
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