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Samsca Safety Alert

The Strom Law Firm is now investigating cases against Samsca

The Strom Law Firm is now investigating and evaluating potential cases against Samsca.  The FDA issued a Drug Safety Communication Tuesday, April 30, 2013.  The safety announcement notes that Samsca should not be used for any longer than 30 days and should not be used in those with an underlying liver disease as it can cause liver injury that may potentially require liver transplant or cause death.

Samsca is a drug used to treat low sodium levels in blood.  Recent clinical trials showed an  increased risk of liver injury when evaluating Samsca’s use in patients with autosomal dominant polycystic kidney disease (“ADPKD”).

The FDA has worked with the drug manufacturer to ensure Samsca’s label includes these new limitations:

  • Limitation of the duration of Samsca treatment to 30 days;
  • Removing the indication for use in patients with cirrhosis- a condition that involves scaring of liver due to injury or long-term disease;
  • Description of liver injuries seen in clinical trials of patients with atuosomal dominant polycystic kidney disease (“ADPKD”);
  • Recommendation to discontinue use of Samsca in patients with symptoms of liver injury.

Otsuka American Pharmaceutical, Inc., the manufacturer of Samsca issued a “Dear Health Care Provider” letter on the potential risk of liver injury January 22, 2013.  The FDA is reviewing the information from the clinical trials of patients with ADPKD and will update the public on the risk of liver injury if more information is available.

What You Need to Know About Samsca

Samsca may cause liver problems, including life-threatening liver failure.  You should contact your health provider immediately if you experience any of these symptoms:

  • Loss of appetite, nausea, or vomiting
  • Fever, not feeling well, unusual tiredness
  • Itching
  • Jaundice- yellowing of the skin or whites of the eyes
  • Unusual darkening of the urine
  • Pain or discomfort in the right upper abdomen, where the liver is located.

The Strom Law Firm Can Help with Defective Drug Recall Cases, Including Against Samsca

Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, like Samsca. We represent individuals who have been killed or injured by defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drug or medical product such as Samsca, contact our defective drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. Call us today at 803.252.4800.



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