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FDA Medwatch Alert: Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death
Posted 30 Apr 2013 by Drugs.com
ISSUE: FDA has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations. BACKGROUND: Samsca is a selective vasopression ...
FDA Medwatch Alert: Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury
Posted 29 Jan 2013 by Drugs.com
ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with ...
Posted 16 Sep 2011 by Drugs.com
FRIDAY, Sept. 16 – Despite ongoing prevention efforts, a growing number of young children are being accidentally poisoned with medications, according to new research. The study, which was based on data reported to the American Association of Poison Control Centers between 2001 and 2008, found that medication poisoning among children aged 5 and under increased by 22 percent, although the number ...