Heparin Ingredient Made In China, No FDA Review

A Chinese facility that has never been inspected by the FDA made the active ingredient in Baxter International’s Heparin blood thinner, which the agency is now reviewing after 350 reports of allergic reactions and four deaths among its users, The Wall Street Journal reports.

An FDA spokeswoman said the plant making the active ingredient “was supposed to be inspected,” but “due to human error, and inadequate information-technology systems, a pre-approval inspection, which would normally be conducted, was not.” Currently, she tells the paper, “preparations are being made to perform an inspection as soon as possible.” The FDA has inspected a Cherry Hill, N.J., facility where the finished version of the drug was made, but adds, but couldn’t provide the name or location of the supplier.

Both Baxter and the FDA said it wasn’t clear that the product from the Chinese supplier is tied to the reactions, the cause of which has not yet been determined. “We honestly don’t know” the cause, the agency spokeswoman told the Journal. An FDA official earlier this week indicated the reactions could even theoretically be tied to the product’s packaging. The drugmaker this week temporarily halted manufacture of multiple-dose vials of its injectable drug.

The disclosure is likely to immediately spark inquiries from Congress and consumer advocates, the Journal writes, noting that lawmakers have already been investigating the safety of drugs imported from overseas. A recent report from the Government Accountability Office found that few foreign factories are regularly inspected, even though they constitute a large portion of ingredients for US drugs.

An FDA official estimated that around 40 percent of the 350 adverse events potentially linked to Heparin were classified as serious. Patient reactions ranged from stomach pain to vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting, the Journal notes.

A Baxter spokeswoman confirmed the active pharmaceutical ingredient comes from a US supplier that operates a plant in China, but declined to identify the supplier. She says Baxter, in cooperation with the FDA, plans to inspect the Chinese factory, but declined to say when. And she tells the paper that Baxter has been working with the US supplier for 20 years, and the supplier has made the ingredient for three decades.

Baxter has only sold Heparin since late 2002, when it bought a unit of Wyeth, the spokeswoman tells the Journal. “There have not been changes” in the Chinese operation, and “it’s not a foregone conclusion” that the Chinese facility is connected to the problem, she insists.

Source: The Wall Street Journal