FDA reports Samsca may cause liver damage

FDA: samsca may cause liver damage
After reviewing data from recent large clinical trials, the U.S. Food and Drug Administration has determined that Samsca (tolvaptan) should not be used for longer than 30 days and should not be used at all by patients with underlying liver disease.

(HealthDay)—After reviewing data from recent large clinical trials, the U.S. Food and Drug Administration has determined that Samsca (tolvaptan) should not be used for longer than 30 days and should not be used at all by patients with underlying liver disease.

Samsca, a selective vasopression V2-receptor antagonist indicated for the treatment of patients with hypervolemic and euvolemic hyponatremia, was shown to increase the risk of in trials evaluating the drug in patients with autosomal dominant .

Samsca's recognized limitations will be reflected in its drug label, created in tandem by the FDA and Otsuka, the drug's manufacturer.

According to the FDA, "Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis. Patients should be aware that Samsca may cause liver problems, including life-threatening , and should contact their health care professional to discuss any questions or concerns about Samsca."

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

FDA: Samsca may cause irreversible liver damage

Jan 26, 2013

(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.

US regulators approve new hepatitis C drug

May 14, 2011

US regulators on Friday approved the first new treatment for hepatitis C in more than a decade, a Merck pharmaceutical known as Victrelis, to be taken with the current two-drug regimen.

Aubagio approved for multiple sclerosis

Sep 13, 2012

(HealthDay)—Aubagio (teriflunomide) has been approved by the U.S. Food and Drug Administration to treat adults with relapsing forms of multiple sclerosis (MS).

Recommended for you

Medical charity warns India over patent rules

Jan 21, 2015

Doctors without Borders on Wednesday warned the Indian government not to bow to US pressure to amend patent regulations that allow millions access to affordable medicines, ahead of a visit by President Barack Obama.

Why are some generic drugs getting so expensive?

Jan 21, 2015

More than eight out of every 10 prescriptions dispensed in the US is generic. This growth is due to a large number of top-selling drugs going off patent over the past decade, as well as innovations in t ...

Supreme Court sides with Teva in drug dispute

Jan 20, 2015

The Supreme Court on Tuesday sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug.

User 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.