Multiple-dose vials of heparin recalled due to severe allergic reactions

Though the doses currently in distribution will not be recalled, FDA urges physicians to use an alternate source.

Reports of serious allergic reactions, hypotension and even death have caused Baxter Healthcare Corporation to temporarily discontinue manufacturing its multiple-dose vials of heparin.

The decision comes only weeks after the company recalled nine lots of its product.

According to an FDA press release, 350 adverse events associated with the product were reported since the end of last year, compared with less than 100 reports in 2007. An overwhelming majority of adverse events occurred in patients receiving the drug in high bolus doses.

Patients receiving heparin for hemodialysis, cardiac surgery and photopheresis are among those most recently affected.

Reactions include difficulty breathing, nausea, vomiting, sweating and rapidly falling blood pressure that could lead to life-threatening shock. Four people died after receiving heparin but the association to the drug is unclear, according to the press release.

The FDA urges health care professionals to select a different source of heparin or use blood-thinning drugs when possible, the press release states.

In the event that only Baxter products are available, the FDA urges health care providers to take the following action:

Do not administer heparin as a bolus, only as an infusion, when possible.
Use the lowest dose necessary at the slowest infusion rate tolerable.
Monitor patients closely for adverse events like hypotension and signs of hypersensitivity.
Consider corticosteroids or antihistamines as pretreatment, though the efficacy of this option is not yet known.

– by Stacey L. Adams