NASHVILLE, Tenn., Dec. 18 Cumberland Pharmaceuticalsannounced today that the U.S. Food and Drug Administration (FDA) has approvedupdated labeling for Acetadote(R) (acetylcysteine) Injection, the company'sintravenous treatment for acetaminophen overdose. The revised package insertprovides new information from a post-marketing safety study reporting a lowerincidence of side effects compared to previously reported data.
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The FDA decision is based on a recent Canadian study evaluating 4,709adults and 1,905 children who were treated with IV acetylcysteine foracetaminophen overdose. Data from the multi-center study comprises the largestknown database addressing the safety of intravenously administeredacetylcysteine. While Acetadote was deemed safe and effective in 2004 upon FDAapproval, this new study found the observed overall rate of reactions commonlyassociated with IV acetylcysteine -- such as urticaria (hives), pruritis(itching) and respiratory symptoms -- to be 8.4 percent, or approximatelyone-half of the 17 percent rate reported in a previous study.
"We are pleased to have access to this large patient database and tocommunicate important new safety information about our product," said A.J.Kazimi, CEO of Cumberland Pharmaceuticals. "As acetaminophen poisoning inadults and children continues to rise(1), we believe this data reinforces theFDA's previous finding that Acetadote offers a valuable treatment option forpatients suffering from this overdose occurrence."
Acetadote is used in the emergency department to prevent or lessenpotential liver damage resulting from an overdose of acetaminophen, a commoningredient in many over-the-counter painkillers. It is the only approvedinjectable product in the United States for the treatment of acetaminophenoverdose, the leading cause of poisonings presenting in emergency departmentsin the country(2).
Acetadote is contraindicated in patients with hypersensitivity or previousanaphylactoid reactions to acetylcysteine or any components of thepreparation. Serious anaphylactoid reactions, including death in a patientwith asthma, have been reported in patients administered acetylcysteineintravenously. Acetadote should be used with caution in patients with asthma,or where there is a history of bronchospasm. The total volume administeredshould be adjusted for patients less than 40 kg and for those requiring fluidrestriction. To avoid fluid overload, the volume of diluent should be reducedas needed. If volume is not adjusted, fluid overload can occur, potentiallyresulting in hyponatremia, seizure, and death.
Please visit www.acetadote.net for the full Prescribing Information, whichalso reflects formatting changes to conform to new FDA mandates.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialtypharmaceutical company that develops and markets niche pharmaceutical productsfor specific physician segments, including hospital acute care andgastroenterology. Cumberland is dedicated to providing high-quality productswhich fill unmet medical needs. For more information, please visit theCumberland Pharmaceuticals web site at www.cumberlandpharma.com.
This release contains forward-looking statements which reflectmanagement's current views of future events and operations. Forward-lookingstatements involve certain significant risks and uncertainties, and actualresults may differ materially from these statements. Cumberland does notundertake to publicly update or revise any of its forward-looking statementseven if experience or future changes show that the indicated results or eventswill not be realized.
(1),(2) National Poison Data System, American Association of PoisonControl Centers
Acetadote(R) is a registered trademark of Cumberland Pharmaceuticals Inc.
SOURCE Cumberland Pharmaceuticals