Certain lots of a drug used to re-start hearts after cardiac arrest are being voluntarily withdrawn from the market because of a possibility that the drug might contribute to some deaths it is supposed to prevent, the government said yesterday.
The Food and Drug Administration announced the drug withdrawal by Abbott Laboratories of North Chicago, Ill. A consumer group last week had urged the agency to act immediately to remove the drug from the market.
FDA representative William Grigg said that the risk of the drug could not be defined at this time but that it was being withdrawn because "there is a theoretical possibility that the drug . . . might add to the burden of the heart . . . after a heart stoppage."
The product is a 10-milliliter syringe containing a solution of epinephrine hydrochloride, which is injected directly into the hearts of patients who have suffered cardiac arrest. Its trade name is Abboject.
Dr. Sidney Wolfe, director of Public Citizen's Health Research, called on FDA to "explicitly warn doctors and other medical personnel not to use these products." Wolfe also recommended that action be taken against Abbott for failing to promptly warn doctors about an acid problem that he said was known last June.
Abbott spokesman Tom Craig said the company agreed to voluntarily withdraw older lots of the drug because "exaggerated press reports" about a medical journal article had raised questions in the medical community. "There are no adverse health consequences involved," Craig said.
He said Abbott changed the formulation of the solution in the syringes last July, in part due to research documenting high acidity in the solution.
Excess acidity may contribute to the cause of death in cardiac-arrest patients who might otherwise be revived, medical experts said.
The company is withdrawing the Abboject syringe made before July, which is in lots with the code 44-145-DK or lower. The syringe made since July is coded 44-146-DK or higher, has less acid and is not in the withdrawal.