Germany's Federal Institute for Drugs and Medical Devices, known as BFARM, asked 10 manufacturers to conduct additional tests and expects results soon, perhaps by next week, Ulrich Hagemann, a pharmaceutical safety official at the agency, tells the paper, although he couldn't name the companies for legal reasons, but said all are German. BFARM's move follows last week's recall in Germany of Heparin made by Rotexmedica GmbH, a unit of the French company Groupe Panpharma. The product was recalled after reports that some patients suffered allergic reactions.
In the US, the FDA has received reports of hundreds of serious adverse events and 19 deaths of patients who appear to have suffered allergic reactions after taking Heparin sold by Baxter International, although it remains unclear how many took the Baxter product. Baxter says the contaminant was found in batches made from an active ingredient made in China.
In a statement, Rotexmedica said the ingredient also came from China. "The supplier of the API is qualified and registered and the API used complies with the agreed specifications," the company said, adding that "it has not been possible to exclude any possibility of a contamination with an unknown impurity."
Rotexmedica said it recalled three batches of heparin last week, and has begun recalling another 12 batches made from the same API "as a preventative action." Hagemann said BFARM last week asked all sellers of Heparin in Germany to report whether they had purchased API in China. But BFARM can't be sure the problem is related to China and has therefore ordered all heparin sellers to test their products for contamination, he said. "We have to look: what are companies doing, what do they import, what do they use for production of their medicinal products?" he said.
The German regulator initially received about 80 reports of allergic reactions in people who took heparin at dialysis centers but has narrowed these down to about 30 cases, he tells the Journal. Reactions included rashes, a decrease in blood pressure, sweating and difficulty breathing, but none died. Three of these cases occurred in people using the Rotexmedica product, he said, but the regulator isn't sure which companies made the heparin taken by the other patients.
Source: The Wall Street Journal