Product News and Recalls

FDA warns Samsca linked to liver injury

The U.S. Food and Drug Administration has issued a warning that the kidney drug tolvaptan, sold under the brand name “Samsca,” carries a risk of liver injuries, “potentially leading to liver transplant or death.”

According to a story on MedPage Today, the drug is used to treat low serum sodium levels.

Last January, the company that markets the drug, Otsuka American Pharmaceutical, notified physicians that it was linked to liver injury.

In a letter to providers, Otsuka American Pharmaceutical stated: “Three patients out of some 1,400 participating in a clinical trial of tolvaptan, a selective vasopressin V2-receptor antagonist, in autosomal dominant polycystic kidney disease (ADPKD) developed increases in serum alanine aminotransferase (ALT) three times above the upper limit of normal, as well as elevated serum total bilirubin above twice the upper limit of normal.”

The FDA statement says Treatment patients should take the drug for a maximum of 30 days, and that patients with underlying liver disease including cirrhosis should avoid taking it.

According to the FDA advisory, the agency has worked with the manufacturer to revise the Samsca drug label to include new limitations.

The advisory also says that patients should contact their health care professionals if they want to discuss any questions or concerns about Samsca.

See the FDA warning here:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350185.htm?source=govdelivery

See the MedPage story here:

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/38766