Baxter Recalls All Heparin, as Reports of Reactions, Deaths IncreaseFeb 29, 2008 | Parker Waichman LLP
Baxter Heparin, implicated in hundreds of life-threatening reaction in the US, is now subject to a full-scale recall. The massive Baxter Heparin recall was announced yesterday, the same day the Food & Drug Administration (FDA) said it completed an inspection of a Chinese plant that supplies raw ingredients for Baxter Heparin. Despite finding problems during that inspection, the FDA still has not determine what is responsible for the tainted Baxter Heparin.
Baxter International recalled 9 lots of its Heparin in January, following reports of 100 allergy type reactions in patients who had received the drug. According to the Baxter Heparin recall notice sent out at the time, a variety of reactions were been reported in relation to the recalled Heparin, including abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. Since the January recall, Baxter Heparin has been implicated in more than 400 reactions, including four deaths.
Following the January Baxter Heparin recall, the company had suspended making Heparin and the FDA warned doctors to avoid using the Baxter drug. Baxter said yesterday that it had waited to issue the full-scale Heparin recall because the company wanted to avoid causing a Heparin shortage. Heparin is a vital drug used in surgery, dialysis, and for the bedridden. Other drugs thin blood, but their effects are not as quick or easily reversed. Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S. The company said that because other manufacturers had been able to step in and increase the supply of the drug, it was now going ahead with a full-scale Heparin recall.
Meanwhile, the FDA has finished its inspection of the Chinese plant that had made a raw ingredient for Baxter Heparin. The FDA said it had found "irregularities" at that plant, but had not determined if they were responsible for the tainted Heparin. The agency also said it was also investigating two Chinese wholesalers that supplied crude Heparin to the Chinese plant, as well as those that sold raw ingredients to the wholesalers.
Among the potential problems the FDA found during the inspection of the Chinese Heparin plant was a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment. According to a redacted inspection report released by the agency, the plant appeared to have made at least some Heparin with “material from an unacceptable workshop vendor.” According to the New York Times, Scientific Protein Laboratories, a Wisconsin company that is the majority owner of the Chinese plant, issued a statement Thursday saying the FDA’s finding did not represent its final determination as to whether the plant complied with federal regulatory rules.
Following the first Baxter Heparin recall in January, the FDA revealed that it had never inspected the Chinese plant before the factory began shipping the Heparin ingredient to Baxter in 2004, a clear violation of US policy. China’s drug agency also did not inspect the plant.