The FDA issued an advisory instructing healthcare professionals and patients to limit the use of Baxter's multi-dose heparin vials, and to switch to other sources of the drug due to reports of severe allergic reactions and hypotension associated with Baxter's product. Baxter also announced that it is temporarily suspending production of multi-dose vials of heparin as it "works to determine the cause of the increase in adverse reactions."

In an update on Monday, the company said the reported adverse events were not limited to nine lots of the multi-dose vials that were recalled in January, but it is not recalling additional lots at this time. Meanwhile, the FDA noted that it has received over 350 reports of adverse events so far this year linked to Baxter's product, compared to fewer than 100 received in all of 2007. Most reports involved intravenous administration of high doses of heparin from multi-dose vials, although the agency said some reports have been received regarding single-dose vials.

Baxter said adverse events have primarily been reported in patients undergoing haemodialysis, invasive cardiovascular procedures, and apheresis procedures. Reported reactions include respiratory difficulties, chest pain and rapid heart rate, nausea and rapidly falling blood pressure. Four deaths have been reported, the FDA said, but the agency indicated that it is unclear whether the deaths were related to the drug.

Janet Woodcock, the acting director of the FDA's Center for Drug Evaluation and Research, commented that the regulator "is vigorously investigating to determine the root cause of these serious reactions." The agency stopped short of issuing a recall for all Baxter multi-dose heparin vials over concerns that the move might result in a severe shortage in the country. The regulator is asking other drugmakers to increase heparin production to offset the loss of Baxter's heparin, which accounts for about half the US supply. The FDA also said it is investigating whether similar side effects have been observed with heparin from other manufacturers.

Reference Articles

Baxter provides update on heparin reactions - (Baxter)

Baxter's heparin may be linked to severe reactions - (Bloomberg)

FDA: Stop use of Baxter blood thinner - (CNBC)

Baxter halts heparin production after reports of allergic reactions - (Chicago Tribune)

Baxter's multiple-dose vial heparin linked to severe allergic reactions - (FDA)

Baxter temporarily suspends manufacture of multi-dose heparin vials - (Forbes)

Baxter added heparin instructions to mitigate risk of reaction - (Morningstar)

Baxter suspends manufacture of some heparin vials - (The Guardian)

Baxter halts heparin production amid reports of allergic reactions - (The Wall Street Journal)