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news.US-based Cumberland Pharmaceuticals has announced that the FDA has approved updated labeling for Acetadote injection, the company's intravenous treatment for acetaminophen overdose. The revised package insert provides new information from a post-marketing safety study reporting a lower incidence of side effects compared to previously reported data.
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The FDA decision is based on a recent Canadian study evaluating 4,709 adults and 1,905 children who were treated with intravenous (IV) acetylcysteine for acetaminophen overdose. Data from the multi-center study comprises the largest known database addressing the safety of intravenously administered acetylcysteine, the company said.
While Acetadote was deemed safe and effective in 2004 upon FDA approval, this new study found the observed overall rate of reactions commonly associated with IV acetylcysteine such as urticaria (hives), pruritis (itching) and respiratory symptoms – to be 8.4%, or approximately one-half of the 17% rate reported in a previous study.
A Kazimi, CEO of Cumberland Pharmaceuticals, said: “We are pleased to have access to this large patient database and to communicate important new safety information about our product. As acetaminophen poisoning in adults and children continues to rise, we believe this data reinforces the FDA’s previous finding that Acetadote offers a valuable treatment option for patients suffering from this overdose occurrence.”