WASHINGTON—Baxter Healthcare Corp. has stopped manufacturing and has recalled all multiple-dose vials of the injectable blood-thinning drug heparin after receiving more than 300 reports of allergic reactions since the start of the year.
Four people have died after receiving heparin, according to the FDA, but it’s still unclear what their connection is to the drug. Some of the serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure, which can lead to life-threatening shock.
Baxter said the adverse reactions happened in three areas: hemodialysis, invasive cardiovascular procedures and apheresis procedures. The company added that it is cooperating with the FDA to start an investigation into the issue and has suspended manufacturing multi-dose heparin vials.
In February, the news broke that U.S. Food and Drug Administration violated its own policy by approving the blood-thinning drug without inspecting the plants in China and Wisconsin that made heparin’s active ingredient.
Since 1980, the FDA has been required to inspect manufacturing plants before a drug can be approved. The New York Times quoted an FDA spokeswoman as saying the problem "was obviously a glitch."
"Although the agency must inspect domestic drug plants every two years, the investigators [from the Government Accountability Office] found that it inspected foreign drug plants at best once every 13 years," according to the New York Times. "The agency’s record in China, now one of the biggest drug suppliers in the world, is even worse. Of the 700 approved Chinese drug plants, the agency has been able to inspect only 10 to 20 each year and would need 40 to 50 years to inspect them all."
The FDA sent a team to inspect the Chinese plant between Feb. 20 and Feb. 26. The inspectors found a number of procedural problems with the Changzhou SPL Co. plant, but still could not pinpoint the exact cause of the side effects.
The reactions generally happened in patients who received large doses of heparin intravenously in a short period of time, according to the FDA. The agency said that these adverse events have not been seen in patients receiving lower doses over longer periods of time. In addition, many of the cases have taken place in dialysis centers.
There have been more than 350 reported cases of adverse events associated with Baxter’s heparin since Jan. 1, according to the FDA. There were less than 100 events reported in 2007.
The Centers for Disease Control and Prevention was first notified of allergic reactions to Baxter’s heparin in January, and this resulted in Baxter voluntarily recalling nine lots of heparin on Jan. 17.
Fearing a nationwide shortage of the blood-thinner in hospitals and dialysis clinics, the FDA and Baxter initially decided against a nationwide recall and instead warned doctors about the risks. In the interim, the FDA said it worked with other manufacturers to fill the void left by Baxter halting production.
Baxter said it annually sells 35 million units of heparin in the United States, which creates revenues of approximately $30 million.
Heparin is made from pig intestines and has been sold in the United States since the 1930s, according to the FDA. And kidney-disease patients are given heparin to prevent blood clotting during dialysis treatments.
