Baxter halts high dosages of heparin
U.S. regulators urged doctors to limit use of Baxter International Inc.'s blood thinner heparin after getting reports of severe reactions among patients taking the drug.
The blood pressure of some patients dropped so low they were at risk of life-threatening shock, the Food and Drug Administration said Monday in a statement. Other reactions included vomiting and difficulty breathing. Four patients have died after receiving injections of heparin, although the relationship to the drug is unclear, the agency said.
Baxter agreed to temporarily halt the manufacture of the drug in the multiple-dose vials associated with the reactions, the FDA and the company said. Heparin, used by millions of people, generates about $30 million in annual sales for Baxter. The Deerfield-based company reported $11.3 billion in total revenue for 2007.
About 350 cases of side effects already have been reported since Jan. 1, compared with fewer than 100 in all of 2007, according to the FDA. Baxter announced on Jan. 25 a voluntary recall of nine lots of the drug in the multiple-dose vials. No further recalls were announced Monday.
Baxter produces about half the multidose vials of heparin in the U.S., according to the FDA. The agency said it's "investigating whether similar events have been seen with other heparin manufacturers."
The drug is a "medical necessity" and a recall would have caused a severe shortage, said John Jenkins, the director of the FDA's Office of New Drugs. The agency is working with APP of Schaumburg and suppliers from overseas to limit a shortage of the drug.
The reactions occurred in patients who took a high dose in a short period of time, not among people on a lower dose taken over a longer period of time, the FDA said. Patients about to undergo kidney dialysis or heart bypass surgery often get the high doses to prevent clotting during the procedure, Jenkins said.
The agency advised doctors to limit the risks by giving heparin as an intravenous infusion rather than in a single high dose and to use the lowest dose possible over a longer period.
The FDA is inspecting Baxter's manufacturing plants looking for trace contaminants that also could come from rubber stoppers in packaging, he said.
Heparin is a complex mix of carbohydrates derived from pig intestines, then purified for use in humans, the FDA said. It has been marketed in the U.S. since the 1930s.
Actor Dennis Quaid sued Baxter late last year, saying his newborn children were wrongly given adult doses of heparin.
The "removal of Baxter's heparin from the market would create more risk to the population of patients requiring heparin therapy than the increased potential for experiencing an adverse reaction," Baxter said in a statement.