Heparin problems spark disagreement between FDA and Chinese authorities
In two different press conferences yesterday, Chinese health officials and FDA scientists presented conflicting views on the source of the recent heparin problems which have caused hundreds of people to suffer severe allergic reactions or die. While a fake chemical has been identified in raw heparin ingredients manufactured at a plant in China, Chinese investigators expressed doubt that the contaminant was the cause of the problems. Meanwhile, the FDA indicated that their data does link the contaminant to the heparin reactions and a letter was released which identified several production problems at the facility in China.
Early in the day yesterday, Chinese health officials held a news conference at their embassy in Washington, D.C. They suggested that the contaminant found in blood thinner ingredients supplied from China was not the cause of the deaths and allergic reactions associated with heparin in the United States. They indicated that the heparin problems may have originated in the United States, and Chinese investigators are continuing to review whether the reactions could be caused by other contaminants, problems with the devices used to inject the drug or health factors with the patients receiving the heparin.
Later in the day, the FDA said that new data does link the contaminant found in the ingredients produced in China to the heparin problems. Through test tube and animal data, U.S. health officials indicate that the contaminant, over-sulfated chondroitin, can trigger the types of allergic reactions which have been tied to 81 heparin deaths in the United States. They found that the problems appear more likely to occur when larger doses of the blood thinner are administered quickly, such as when heparin is used in kidney dialysis treatment or cardiac surgery.
The FDA also released a letter on Monday which was sent to Changzhou SPL, the Chinese manufacturer of the contaminated heparin ingredient. Following inspections of the facility on February 20-26, the FDA cited the manufacturer for failing to have adequate systems in place to ensure that raw heparin materials they produced were safe and without impurities. The plant had “significant deviations” from good manufacturing processes and the equipment used to make the heparin ingredients was deemed “unsuitable for intended use.” Inspectors found that production tanks that had been labeled as “clean” contained “unidentified material…adhering to the inside surfaces.”
Since the heparin problems surfaced, a lot of controversy has surrounded the FDA’s oversight of foreign drug production. The Chinese facility where the heparin ingredients were made was never inspected by FDA officials due to a mix up over the name of the manufacturer. Now the agency has informed the Chinese manufacturer that no active pharmaceutical ingredients produced by the company will be allowed into the United States until the problems are addressed.
HEPARIN LAWSUITS
The lawyers at Saiontz & Kirk, P.A. represent individuals who are pursuing a heparin lawsuit after suffering problems following the use of the blood thinner. The heparin problems could result in allergic reactions with symptoms such as nausea, vomiting, shortness of breath and severe drop in blood pressure. Heparin lawsuits are being investigated on behalf of individuals who died or suffered severe physical injury as a result of the problems. To determine if you, a friend or family member may be entitled to financial compensation, request a free consultation and claim evaluation.
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