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

Supercomputers link proteins to drug side effects

Oct 20, 2014

New medications created by pharmaceutical companies have helped millions of Americans alleviate pain and suffering from their medical conditions. However, the drug creation process often misses many side ...

No added benefit proven for umeclidinium/vilanterol in COPD

Oct 20, 2014

The drug combination umeclidinium/vilanterol (trade name Anoro) has been approved since May 2014 for adults with chronic obstructive pulmonary disease (COPD). In an early benefit assessment pursuant to the Act on the Reform ...

User comments