A leading manufacturer of the blood-thinner heparin recalled the drug in the wake of adverse events and perhaps 19 deaths in the United States.
The recall – and the issuance of a government public health advisory – came after reports of 350 adverse events in January 2008, far more than the typical number. There was concern that the problem occurred because of the possible use of a counterfeit ingredient made in China.
Nearly all of the adverse events, some considered life-threatening, were noted when heparin was injected into patients undergoing kidney dialysis, certain cardiac surgeries and for the treatment or prevention of deep venous thrombosis and pulmonary emboli.
In all, said U.S. Food and Drug Administration officials, certain batches of heparin may have been ked to at least 19 deaths and more than 700 severe allergic reactions in the United States.
The FDA said some of the side effects noted were stomach pain, vomiting, low blood pressure, chest pain, fast heart rate, fainting, flushing, headache, shortness of breath and bleeding tendencies. Other side effects included nausea, diarrhea, dizziness, unresponsiveness, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, sweating, decreased skin sensitivity, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth.
Baxter International first removed nine lots of multi-dose heparin on Jan. 17, 2008 due to an increase of reported adverse events. On Feb. 28 it expanded the recall to all remaining lots of the anticoagulant, including single-vial doses, as well as its heparin lock flush products. Baxter International had been selling about 100,000 doses of heparin annually.
On March 7, medical officials in Germany announced a recall of heparin made in that country by RotexMedica GmbH because it was believed to be linked to contaminated ingredients made in China. They reported 80 patients had suffered adverse events including shortness of breath, low blood pressure and rapid heartbeats.
A few days later, three Japanese companies also recalled heparin products made with raw ingredients from China. And on April 2, U.S. heparin manufacturer Covidien announced it was recalling 32 lots of pre-filled heparin syringes because of contamination. The FDA said the company was reacting to a notice from Scientific Protein Laboratories (SPL), which supplies Covidien with the active ingredient used in heparin. SPL is also the supplier to Baxter.
Heparin is a widely used blood thinner that is derived from cow and pig intestines, with raw active ingredients often imported in bulk from China, considered the world’s leading source of heparin.
FDA officials announced after the Baxter International recall that they were asking all U.S. heparin producers to test the medication using two new procedures – nuclear magnetic resonance spectroscopy and capillary electrophoresis, the only tests that can uncover whether heparin contains a possibly counterfeit ingredient.
Kline & Specter, PC, a law firm based in Philadelphia has had success litigating product liability and prescription drug lawsuits.
- FDA says heparin contaminant found in China processing plant
- Concerns about the safety of the blood thinner heparin have spread to Germany after drug authorities there received reports of patients being sickened after getting the drug.