FDA issues Samsca warning over liver injury risk

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by Jim Orr

The FDA and drug manufacturer Otsuka are notifying healthcare professionals of “significant” liver injury associated with the use of the drug Samsca. The agency is urging clinicians to conduct liver tests promptly in patients who report symptoms that may indicate liver injury.

Three participants in a large study of patients with autosomal dominant polycystic kidney disease who were treated with the drug “developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin.” On discontinuation of treatment, all three patients improved, said the agency. An external panel that reviewed the cases concluded that the issues were “probably or highly likely to be caused by tolvaptan.” According to the FDA, these findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.

Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of hyponatremia (low blood sodium levels). Samsca is not approved for the treatment of ADPKD.

The FDA is recommending that healthcare providers perform liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. 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 liver injury is definitively established to be unrelated to treatment with Samsca.

The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions. As a result, we have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. We have represented hundreds of people regarding dangerous fentanyl pain patches, defective hip and knee implant devices, Yaz, Actos, Avandia and Accutane—to name just some examples.

Heygood, Orr & Pearson is AV-rated, the highest legal and ethical rating available from the leading law firm rating service. Our partners Michael Heygood, Jim Orr, and Eric Pearson are all Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization. Mr. Heygood and Mr. Orr are additionally Board Certified in Civil Trial Advocacy Law by the National Board of Trial Advocacy. Our partners been voted by their peers as “Super Lawyers” in the state of Texas for several years in a row.*

At Heygood, Orr & Pearson, we believe that when a drug company sells a drug or medical device that is dangerous and unsafe, they should be held responsible for the damage. In addition, we have the resources and experience to protect a person’s rights and the rights of their loved ones against irresponsible pharmaceutical companies and medical device manufacturers.

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Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.