Drug Injury

Stewart & Stewart Injury Lawyers

Heparin Nationwide Recall

There has been an urgent nationwide recall of heparin units manufactured by Baxter Healthcare Corporation and B. Braun Medical Inc. The recall is the result of an increased number of adverse reactions to the drug, some of which may be life-threatening.

According to the Food and Drug Administration (FDA), reactions to the recalled heparin doses include:

• 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
• Difficulty opening the mouth

If you are experiencing these symptoms after receiving the drug heparin (probably during dialysis or a heart procedure), you may need to speak with a heparin lawyer at our firm.

Update:

In February of 2008, the FDA learned of a steep increase in adverse events involving heparin sodium injections and launched an investigation in both the United States and China, where some heparin ingredients are supplied from.

The investigation discovered that a chemical close in nature to heparin—but not, in fact, heparin—was present in some of the ingredients supplied by a certain lab that made its way into the heparin injections. The chemical, considered a contaminant by the FDA, was discovered in significant amounts--up to 20% in some cases--in the recalled batches.

It is believed that this contaminant is the cause of the adverse reactions in many recipients of the tainted heparin, although no definitive link has been established.

The FDA later issued the following statement:
"There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded [...] Serious adverse events have recently been reported in patients who received these higher bolus doses."

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

Source: FDA’s Information on Heparin Sodium Injectionhttp://www.fda.gov/cder/drug/infopage/heparin/default.htm.

Update II:

Yet another manufacturer has recalled certain lots of heparin because product was contaminated. Covidien has issued the recall after discovering that thirty-two lots of its heparin product contained a "heparin-like contaminant."

Source:Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin

What is heparin?
Heparin is a prescription injectable blood thinner commonly used for hemodialysis (the use of a dialysis machine to clean or filter the blood in kidney failure patients) and during invasive heart procedures.

Heparin is one of the oldest drugs still in widespread clinical use and acts as an anticoagulant to prevent blood clots.

What should I do if I was exposed to recalled heparin?
Consult your doctor if you are experiencing any of the above symptoms, as the FDA warns that some reactions may be severe or life threatening. If you’ve become ill after exposure to recalled heparin, you may need to contact a heparin lawyer at our firm immediately. We may be able to help you or someone you care about.

Source: “Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials” from the Food and Drug Administration. Accessed 1/25/08 viawww.FDA.gov.

This law firm is not associated with, sponsored by, or affiliated with Baxter Healthcare Corporation, Covidien, or the Food and Drug Administration.

This article is for informational purposes only and does not constitute medical advice.