When to contact an attorney
If you have suffered a personal injury as a result of the dangerous drug Heparin, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation and dangerous drug litigation against pharmaceutical companies.
Heparin Adverse Events from FDA
Serious injuries and deaths have been associated with the use of Heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, angioedema, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.
- There have been 246 reports of death reported to FDA since January 1, 2007; 238 were reported to FDA on or after January 1, 2008.
- Of the 149 reports that included one or more allergic symptom(s) or symptoms of hypotension and death, 146 were reported to FDA on or after January 1, 2008.
- The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases.
- FDA received reports of 97 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.
- In the majority of reports with a death outcome, there was not enough clinical information to assess the relationship between death and the use of heparin.
Heparin Changes
On October 1, 2009, the United States Pharmacopeia (USP) changed the standard for how the amount of heparin (the “USP unit”) is determined in products used in the United States. USP is an organization that sets standards for the quality, purity, strength, and consistency for medicines sold in the United States. These changes will make the amount of heparin available in a single “USP unit” dose the same as the “International Unit” that is used in most other countries. As a result, overall, heparin in the U.S. will be about 10% less potent, unit for unit, than it is today.
Medtronic Heparin Recall
Medtronic, Inc. today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration’s April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.
Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.
Covidien Heparin Recall
Covidien, formerly Tyco Healthcare, was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nation-wide recall of Heparin Sodium USP active pharmaceutical ingredient. The voluntary recall affects 32 lots manufactured and distributed by Covidien in the United States.
B. Braun Medical Heparin Recall
B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.
American Health Packaging Heparin Recall
American Health Packaging (AHP), a subsidiary of AmerisourceBergen Corporation (NYSE:ABC), today announced a voluntary recall of 1,421 units (25 vials per unit) of 10000 USP units/ml heparin sodium injection 1ml vials as part of the broader February 29, 2008 recall of Heparin products made by Baxter Healthcare Corporation. The vials were manufactured by Baxter and then placed by AHP into individually labeled bags for use in pharmacy automation equipment. The AHP packages where sold to five hospitals in Georgia and California, all of whom were notified of the recall earlier this month. Baxter Healthcare will reimburse AHP for the recalled product.
Baxter Heparin Recall
Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type reactions.
Adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Some of these reactions may be severe or life threatening.