Tainted Heparin Kills 62
April 9, 2008
The FDA said today there have been 62 fatal allergic reactions following the use of contaminated heparin.
In the 15 months from Jan. 1, 2007 through March 31, 2008, the FDA received reports of 103 deaths following heparin use, but only 62 of the deaths were linked to one or more allergic reactions, including severe hypotension, that have been linked to contaminated heparin.
The FDA has identified as the “heparin-like” contaminant called hypersulfated chondroitin sulfate in crude heparin from Scientific Protein Laboratories’ plants in Zhangzhou, China, and Waunakee, Wis.
Popularity: 64% [?]
FDA Missed Heparin Plant Inspection in China
February 19, 2008
A mix-up with similar names meant the FDA did not inspect a Chinese plant that makes the active ingredient in the heparin products linked to a recent spike in adverse events.
The mix-up wasn’t discovered until recently and an FDA inspection team is now headed to China to remedy the lapse, FDA officials said today in a press conference.
In principle, a foreign plant that makes an active pharmaceutical ingredient for use in products sold in the U.S. is inspected before the product is approved, said Joseph Famulare, deputy director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research.
But if the plant has been recently inspected for another product, the agency may rely on paperwork from the previous inspection, Famulare told reporters.
The Changzhou SPL plant in China, which makes the active ingredient in Baxter Healthcare’s multiple-dose vials of heparin sodium, had not been inspected and should have been, Famulare said.
Popularity: 54% [?]
Heparin Sodium Injection Serious Adverse Events
February 18, 2008
FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.
The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.
Popularity: 55% [?]
