Heparin recalled in Europe and Australia as Covidien initiates voluntary recall of syringes in U.S.

Australia's Therapeutic Goods Administration (TGA) March 26 warned doctors and patients about the safety of the blood thinner heparin after finding a contaminated sample distributed by AstraZeneca, Bloomberg News reported, while France, Italy and Denmark also recalled the blood-thinning drug heparin or its ingredients, raising the question of whether a previously trusted supplier may have contamination problems, according to "The Wall Street Journal."

"It is unclear whether the contamination is related to single batches or affects heparin products more generally," TGA said in a statement on its Web site http://www.tga.gov.au/alerts/index.htm#latest There has been no increase in the number of reports associated with the drug, the regulator said. Doctors should use heparin "only where it is medically essential," the TGA said.

The European withdrawals hold potential worry for the United States. China's Shenzhen Hepalink Pharmaceutical Co., which supplies ingredients to APP Pharmaceuticals--currently the sole supplier of large-dose heparin for surgery and kidney dialysis in the U.S.--also supplied Italian company Opocrin SpA, which announced that some ingredients it bought from Shenzhen turned out to be contaminated.

APP, based in Schaumburg, IL, said the Italian heparin ingredients were obtained through a different slaughterhouse than are APP's. APP heparin has consistently tested contaminant-free in its own and in FDA testing, APP spokeswoman Maili Bergman told The Journal.

There have been no reports of patients in France, Italy or Denmark suffering adverse events after taking heparin. But some batches of finished heparin and its active pharmaceutical ingredient are being recalled because they are contaminated or suspected of being contaminated, Martin Harvey-Allchurch, a spokesman for the European Medicines Agency (EMEA), based in London, said.

"We presume it is the same contaminant," over-sulfated chondroitin sulfate, as found in batches of heparin in the U.S., because the screening test being used is specifically designed to identify that particular contaminant, he said. The EMEA has been in close contact with FDA on heparin and has passed along FDA's contamination-screening test to all European Union countries, Harvey Allchurch said. He added that he believed all EU countries are now testing their heparin batches for contamination.

An FDA spokeswoman said the agency has tested APP heparin batches in the past and found no contamination, and APP has promised to test the active ingredient for its U.S. heparin for the contaminant.

France started recalling finished heparin made by Rotexmedica, the same company that made heparin that was recalled from the German market earlier this month, Harvey-Allchurch said.

In the U.S., Covidien, formerly Tyco Healthcare, began a voluntary recall March 28 of 32 lots of pre-filled heparin syringes in the U.S. after its supplier, Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien had a heparin-like contaminant.

Covidien began recalling the lots as a precautionary measure, FDA noted. To date, the company has not received any adverse event reports related to this issue.

FDA has received at least 785 adverse event reports of which 21 were deaths related to the heparin in question. Typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.