FDA: Samsca may cause irreversible liver damage

January 26, 2013
FDA: samsca may cause irreversible liver damage
Patients who take Samsca (tolvaptan) may be at elevated risk for significant liver injury, according to a Jan. 25 safety alert issued by the U.S. Food and Drug Administration.

(HealthDay)—Patients who take Samsca (tolvaptan) may be at elevated risk for significant liver injury, according to a Jan. 25 safety alert issued by the U.S. Food and Drug Administration.

The FDA and Otsuka notified health care providers of this potential risk after three patients with Autosomal Dominant (ADPKD) participating in a drug trial developed significant increases in serum alanine aminotransferase, along with significant increases in serum total bilirubin. The patients were taking a higher dose (90 mg in the morning and 30 mg in the afternoon) than the 60-mg dose approved for hyponatremia. Samsca is not approved for treating of ADPKD.

An external panel of liver experts determined that tolvaptan was most likely the culprit in these three cases; all of the patients improved once they stopped taking the drug.

" should perform liver tests promptly in patients who report symptoms that may indicate liver injury," the authors write. "If hepatic injury is suspected, Samsca should be promptly discontinued, appropriate treatment should be instituted, and investigations should be performed to determine probable cause. Samsca should not be re-initiated in patients unless the cause for the observed is definitively established to be unrelated to treatment with Samsca."

Explore further: Common antibiotics pose a rare risk of severe liver injury in older patients

More information: More Information

Related Stories

Recommended for you

Why kicking the opioid habit can be so tough

July 20, 2016

(HealthDay)—He was 26, a specialist fifth class with the U.S. Army, and stationed abroad, when an accident on the German autobahn sent him careening through the windshield of his car.

New research shows vaccine protection against Zika virus

June 28, 2016

The rapid development of a safe and effective vaccine to prevent the Zika virus (ZIKV) is a global priority, as infection in pregnant women has been shown to lead to fetal microcephaly and other major birth defects. The World ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.