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Tolvaptan News

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 V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca for a new use in patients with autosomal dominant polycystic kidney disease (ADPKD). RECOMMENDATION: Samsca treatment should be stopped if the patient develops signs of liver ... Read more

Related support groups: Tolvaptan, Hyponatremia, euvolemic, Samsca

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 concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia. Most of the liver enzyme abnormalities were observed during the first 18 months of therapy. Following discontinuation of treatment, all 3 patients improved. An external panel of liver experts assessed these 3 cases as being either ... Read more

Related support groups: Hyponatremia, Tolvaptan, Samsca

Accidental Medication Poisonings in Kids on the Rise

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 of children in the United States in this age group rose by only 8 percent during the study period. "The problem of pediatric poisoning in the U.S. is getting worse, not better," Dr. Randall Bond, of Cincinnati Children's Hospital Medical Center, said in a hospital news release. In conducting the study, which is scheduled for publication in the Journal of Pediatrics, the researchers reviewed information on over 544,000 children who landed in the emergency department due to medication poisoning ... Read more

Related support groups: Xanax, Suboxone, Oxycodone, Hydrocodone, Methadone, Percocet, OxyContin, Klonopin, Vicodin, Lisinopril, Norco, Fentanyl, Clonazepam, Morphine, Ativan, Ambien, Valium, Codeine, Metoprolol, Lortab

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Further Information

Related Condition Support Groups

Hyponatremia, Hyponatremia, euvolemic

Related Drug Support Groups

Samsca

Tolvaptan Patient Information at Drugs.com