Cadence Recalls OFIRMEV Due to Unidentified Particle

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Cadence Pharmaceuticals, Inc., announced Feb. 6, 2012, it was voluntarily recalling a single lot of its injectable acetaminophen product OFIRMEV®, used primarily for patients in the hospital.

Use of OFIRMEV® and Recalls Causes

OFIRMEV® is prescribed to treat mild to moderate pain and moderate to severe pain in conjunction with opioid analgesics and to treat fever. The manufacturer warned that the pain control medication might mask fever in patients following surgery.The recalled lot number is V005710. The recall was undertaken because an unidentified visible particle was found in one vial of the lot during routine stability testing. Cadence distributed the tainted lot beginning in January 2011 to hospitals, wholesalers and distributors. The company said it thinks that fewer than 1,000 vials are currently on the market.No adverse events associated with particulate matter have been reported to Cadence. The pharmaceutical company said it was taking the action as a precautionary measure.

What the Clinical Tests Says

Clinical trials leading up to the drug’s approval involved 1,020 adults and 355 children. Two of the trials were conducted to determine the safety and effectiveness of OFIRMEV® in treating pain. One trial tested the drug in treating fever. The efficacy of the medication has not been tested in children younger than two years old.The company warned patients not to exceed the daily dose of acetaminophen. Taking acetaminophen by any route in doses higher than recommended could injure the liver, the warning said, including severe toxicity to the liver and death.Health care providers are cautioned to administer OFIRMEV® for no more than a 15-minute intravenous infusion of the drug to patients with impairment or active disease of the liver, alcoholism, chronic malnutrition, severe hypovolemia (low blood volume), or severe kidney malfunction.Source: Sacramento Bee