The contaminated heparin is believed to have come from farms around Changzhou, China. This toxic compound mimics real heparin, but costs less to make and may have been added to the supply. Because China is beyond the reach of U.S. regulators, these tainted heparin shipments were able to make their way into the U.S., Canada and elsewhere. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research says, “Contamination of the heparin supply is a worldwide problem.”

Overdose due to unclear labeling of products may also be a factor in some of the reported deaths. HepLock, a diluted form of heparin which is designed for use in children, has been sold in vials that are the same size, shape, and with similar labeling to full strength heparin. This creates confusion and more than one pharmacist or health care provider has mistakenly given the wrong drug to a patient.

While some of the reported deaths cannot be conclusively linked to heparin since the patients were ill and may have suffered from other causes, there is enough evidence suggesting heparin may have been the cause to create concern.

The Faces of Grief

The tragedy of these deaths has had far reaching effects. Leroy Hubley lost both his wife and son to contaminated heparin. An emotional Hubley told a U.S. House of Representatives subcommittee hearing, “Now I am left to deal not only with the pain of losing my wife and son, but anger that an unsafe drug was permitted to be sold in this country.”

Relatives of other victims have come forward to urge the public to insist that greater measures be taken to assure that life-saving medications are free from contamination. Some have criticized the FDA for not making closer inspections of China’s plants.

Baxter International, Inc.

Baxter International is one of the largest producers of heparin in the U.S. and has been at the center of the controversy. After reports of sometimes severe reactions in patients who had been given the drug, Baxter voluntarily recalled nine lots of heparin on January 17, 2008.

Approximately a month later, as reports of injuries and deaths continued to rise, Baxter recalled virtually all of its heparin products as precautionary measures. These products included al single-dose vials of heparin as well as the diluted solution, Hep-Lock, a flushing product used to prevent blood clots from forming in intravenous lines.

If you have lost a loved one due to a heparin overdose or contaminated heparin, you may be able to receive compensation. Fill out the form to the right for more information on this drug and its effects.

Children are often at greatest risk of heparin overdose. For one, children’s metabolism is different from adults and caution must be used when administering any drug to young children. Another reason may be a matter of labeling. A diluted form of heparin called HepLock which is made specifically for children is often sold in vials that are the same size, shape and with similar labeling as adult heparin.

Several tragic infant deaths have been attributed to heparin overdose. In 2006 three infants in and Indiana hospital died after being administered the adult 10,000 units/mL vial instead of the 10 units/mL vial meant for children. A few months previous to this incident, heparin made world news when actor Dennis Quaid’s newborn twins and another infant were given an overdose of heparin at Cedars-Sinai Medical Center in California. In both cases, the adult and children’s heparin were labeled with a similar blue label. Since this experience, Quaid has become a vocal advocate for the prevention of medical errors.

In 2008 at least 17 infants in a Corpus Christi hospital were accidently given a heparin overdose which resulted in at least two deaths. In this situation, the overdose was due to hospital error rather than confusion over labeling. Nurses were using the blood thinner to flush IV tubes, a common practice, to prevent blood clots from forming. However, pharmacists had erroneously mixed the solution and made a dose that was over 100 times too strong.

To date there have been nearly 300 medical errors concerning children under 18 months of age.

Heparin overdoses have also occurred in adult patients. One patient was given a dosage ten times too strong because the pharmacist couldn’t read the doctor’s handwriting on the prescription: an abbreviation for units was mistaken for an extra zero. The patient was given an antidote and survived with no long term effects.

Antidote

Protamine sulfate is the typical antidote given in case of a heparin overdose. Protamine sulfate counteracts the anti-clotting effects of heparin by binding to the molecules.

The usual dosage is one mg administered very slowly for every 100 IU of heparin a patient has taken.

Although many hospitals are becoming more vigilant and attempting to install safeguards against accidental overdoses, there is still a margin for human error and heparin overdose remains a serious concern.

If you have a child who has died or been injured as the result of heparin overdose, you may want to file a lawsuit. While there is no compensation for the loss of a child, you may be able to prevent the same tragedy from happening to others.

Anytime you take medications, side effects may occur. This is dependent on many things such as age, alcohol use, over-the-counter medications such as aspirin, your unique body composition, your sensitivity to foreign agents, your overall health and the time of administration. Even your diet, amount of sleep or stress in your life can affect the way you react to medication. Proper administration and strength of dosage may also have an effect.

Many people take heparin with little or no side effects while others can have severe allergic reactions. Some of these reactions can be quite serious and even life-threatening.

Injuries, on the other hand, can often be prevented by vigilance on the part of drug companies and education of health care providers.

Symptoms of Injuries

Drugs.com, an online drug information site dedicated to educating and informing the public about medication lists the following possible reactions to heparin as serious concerns and recommends immediate treatment if you experience any of them:

• rash, hives, itching
• difficulty breathing
• tightness in the chest
• swelling of the mouth, face, lips or tongue
• black, tarry or bloody stools
• bleeding from the gums when brushing or flossing teeth
• blood in the urine
• calf or leg pain
• tenderness or swelling
• chest pain
• confusion
• coughing up blood
• excessive bleeding from cuts
• fever or chills
• increased menstrual bleeding
• lower back pain
• nosebleeds
• excessive numbness or color change of the skin, fingers or toes
• one-sided numbness or weakness
• severe headache or dizziness
• severe or persistent pain, swelling or redness at the injection site
• shortness of breath
• slurred speech
• stomach pain or swelling
• unexplained vaginal bleeding
• unusual bruising
• vision problems
• vomit that looks like coffee grounds

The most common side effect of heparin or the heparin flush is likely to be bleeding or hemorrhaging and can generally be controlled by withdrawing the drug. Two types of Heparin Induced Thrombocytopenia (HIT)–Type I and Type II which results in a low platelet count have also been reported in a significant number of patients. Type I in usually not serious and doesn’t require intervention or other treatment. Type II, on the other hand, may have serious consequences if not addressed.

If you or a loved one has suffered from any of these heparin-indued side effects, you may be eligible to receive compensation from the appropriate manufacturer. Fill out the form to the right if you would like to talk to one of our representatives or get help finding a personal injury lawyer.

It’s also an unfortunate fact that even if you are doing everything correctly, you may be exposed to tainted heparin or have fallen into the hands of incompetent health care providers. If you believe you may be having a severed allergic reaction to heparin or a heparin lock flush, don’t hesitate! Get yourself to the nearest medical facility. Your life may depend upon it!

Drugs.com, an online drug information site dedicated to educating and informing the public about medication lists the following possible reactions to heparin as serious concerns and recommends immediate treatment if you experience any of them:

• rash, hives, itching
• difficulty breathing
• tightness in the chest
• swelling of the mouth, face, lips or tongue
• black, tarry or bloody stools
• bleeding from the gums when brushing or flossing teeth
• blood in the urine
• calf or leg pain
• tenderness or swelling
• chest pain
• confusion
• coughing up blood
• excessive bleeding from cuts
• fever or chills
• increased menstrual bleeding
• lower back pain
• nosebleeds
• excessive numbness or color change of the skin, fingers or toes
• one-sided numbness or weakness
• severe headache or dizziness
• severe or persistent pain, swelling or redness at the injection site
• shortness of breath
• slurred speech
• stomach pain or swelling
• unexplained vaginal bleeding 
• unusual brusising
• vision problems
• vomit that looks like coffee grounds

The most common side effect of heparin or the heparin flush is likely to be bleeding or hemorrhaging and can generally be controlled by withdrawing the drug. Two types of Heparin Induced Thrombocytopenia (HIT)–Type I and Type II which results in a low platelet count have also been reported in a significant number of patients. Type I in usually not serious and doesn’t require intervention or other treatment. Type II, on the other hand, may have serious consequences if not addressed.

If you or a loved one has suffered from any of these heparin-indued side effects, you may be eligible to receive compensation from the appropriate manufacturer. Fill out the form to the right if you would like to talk to one of our representatives or get help finding a personal injury lawyer.

2008 Recalls

The first recall came on January 17, 2008. At that time approximately 150 reports had been received of adverse reactions including stomach and chest pain, dizziness, vomiting, headache, fainting, low blood pressure, sweating, throat swelling among others.

Some of the reactions are severe and even life-threatening.

A number of deaths are also believed to be related to contaminated heparin or severe allergic reactions to the drug.

The batches affected in this recall are:

NDC numbers:

• 0641-2440-45
• 0641-2440-41
• 0641-2450-45
• 0641-2450-41.

Lots:

• 107054
• 117085
• 047056
• 097081
• 107024
• 107064
• 107066
• 107074
• 107111

In February 2008, Baxter Healthcare also recalled both multi-does and single dose vials of heparin sodium used for injection. It also recalled HEPLOCK heparin flush products. The FDA launched an investigation and discovered that contaminated heparin has also been found in some medical devices such as catheters. Some of these have also been recalled.

2009

The death toll continues to rise, as does allergic reactions to heparin.

At least one death and two illnesses were reported at the Beebe Medical Center in Lewes, Delaware after patients were given Baxter supplied heparin. The latest batches were manufactured in Ohio, not China. Although the FDA has cleared Baxter, it is clear that there are still dangers associated with heparin use.

The heparin involved in the Delaware incident was premixed intravenous bags rather than the over-sulfated chondroitin (OSCS), a heparin-mimicking substance.

The Delaware victims suffered intracranial bleeding and severe low blood pressure.

The FDA and Baxter both sent medical teams to test the heparin. FDA spokeswoman, Karen Rilely says “As far as we can determine at this pint, it appears to be an isolated incident.”

In many cases, a patient may have other medical conditions that caused the reaction which makes it difficult to determine whether or not the heparin was to blame. Patients who believe they are experiencing allergic reactions should seek immediate medical help.

If you or a loved one have experienced heparin-related problems, you may have a case. If you would like to speak to a legal representative or need help finding an attorney, please fill out the form to the right.

The primary manufacturer of heparin is Baxter Healthcare. 

What exactly is this drug and why is it causing such a stir?

Definition

Heparin is an anticoagulant (anti-clotting) medication, commonly referred to as a blood thinner. Used properly, heparin makes the anti-clotting protein in your body function better and decreases the ability of the blood to clot.

Heparin is made from pig intestines and it has been marketed in the United States since the 1930s.

It is available as a liquid and is injected intravenously. A less concentrated solution is sometimes injected into intravenous catheters. It is generally administered by a nurse or health care provider, although some patients may be instructed in injecting the medication on their own at home.

Uses of Heparin

Heparin is used to prevent and treat blood clots in the veins, arteries and lungs. These are known as thromboembolic complications; in other words, clots that travel from their site of origin through the blood stream and clog up another vessel. It is often used in the early stages of pulmonary embolisms–blood clots in the lungs.

Heparin is commonly used in certain types of surgeries, such as coronary artery bypass graft surgery. Kidney patients are also often given heparin before undergoing dialysis.
Some medical devices also are coated with heparin and some diagnostic testing products use heparin when they are manufactured. 


One of the serious complications that frequently arises with heparin use is heparin-induced thrombocytopenia, a bleeding disorder. The thrombocytopenia may be the result of the development of a heparin-dependent antibody that causes platelet aggregation and release. There are two types of heparin-induced thrombocytopenia. Type I is generally mild and while it requires careful monitoring, it general doesn’t require a person to stop using heparin. Type II is more serious, usually occurring 7-10 after heparin therapy has begun. In the case of Type II, the heparin should be stopped immediately and replaced by another anticoagulant.

Structure of Heparin

Wikipedia provides the following information on the structure of heparin:

“Native heparin is a polymer with a molecular weight ranging from 3 kDa to 50 kDa, although the average molecular weight of most commercial heparin preparations is in the range of 12 kDa to 15 kDa. Heparin is a member of the glycosaminoglycan family of carbohydrates (which includes the closely-related molecule heparan sulfate) and consists of a variably-sulfated repeating disaccharide unit.[5] The main disaccharide units that occur in heparin are shown below. The most common disaccharide unit is composed of a 2-O-sulfated iduronic acid and 6-O-sulfated, N-sulfated glucosamine, IdoA(2S)-GlcNS(6S). For example, this makes up 85% of heparins from beef lung and about 75% of those from porcine intestinal mucosa.[6] Not shown below are the rare disaccharides containing a 3-O-sulfated glucosamine (GlcNS(3S,6S)) or a free amine group (GlcNH3+). Under physiological conditions, the ester and amide sulfate groups are deprotonated and attract positively-charged counterions to form a heparin salt. It is in this form that heparin is usually administered as an anticoagulant.

One unit of heparin (the “Howell Unit”) is an amount approximately equivalent to 0.002 mg of pure heparin, which is the quantity required to keep 1 mL of cat’s blood fluid for 24 hours at 0°C.[7]“