Baxter withdraws heparin blood thinners made from Chinese supplies
29 February 2008
Baxter International withdrew nearly all its heparin blood-thinning products on 28 February, after the severe allergic reactions they were reported to have caused in some patients. Baxter's heparin products have been linked to four deaths in January this year and over 400 reports of severe allergic reactions, according to the US Food and Drug Administration.
Heparin is a vital drug that is used in various medical and surgical procedures. Baxter had delayed the full recall for six weeks on the advice of the FDA, which wished to ensure that another US manufacturer, APP Pharmaceuticals, would be able to ramp up production to avoid a shortage. The company had already stopped manufacturing these products earlier in February.
The recall once again brings the safety of Chinese products imported into the US into the limelight. This time the controversy revolves around a Chinese plant, Changzhou SPL, near Shanghai, which is behind half of America's supplies of heparin. The Chinese unit is a joint venture of Waunakee, Wisconsin, based Scientific Protein Laboratories LLC.
The US Food and Drug Administration found the heparin products to contain impurities caused by "potential deficiencies" at the Chinese plant that supplied much of the active ingredient for the drug. References have been made to impurities, the quality and use of equipment, and lack of quality control.
FDA inspectors referred to "at least one instance" of the company using active ingredients made from pig intestines supplied by a workshop, which were considered "unacceptable". It turns out that the FDA inspection was not done at the Chinese plant designated for these supplies to Baxter but at another plant.
The FDA has issued an update on the recall, informing the public that Baxter Healthcare has extended its recall to single-dose as well as multi-dose vials of heparin sodium for injection. It said that as a precautionary measure Baxter was also recalling its heparin lock flush products since the ingredients for these products come from the same Chinese source that supplies ingredients for Baxter's heparin sodium for injection.
According to Baxter, "Nearly all reported adverse reactions have occurred in three specific areas of product use - renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening."
The 'drug shortages team' at FDA has been working closely with APP, the other US supplier of heparin multi-dose and single-dose vials, to ensure that APP can now adequately supply the US market. The FDA has also confirmed that there are multiple US suppliers of heparin lock flush products with substantial inventory, making a shortage of these products unlikely.