Baxter Healthcare Corporation, a maker of heparin, has issued a nationwide recall of its version of heparin. Heparin is a blood thinner (anticoagulant) which has been manufactured since 1930. It is used in heart surgery, dialysis, and other procedures. Heparin prevents blood clots from forming. It can have very dangerous side effects, but it can also save lives and many patients depend on it. Baxter is not the only company which makes heparin, but the recall was delayed to prevent a potential shortage of the drug.
The Problem with Heparin Made by Baxter
Over 400 people have report side effects and 21 have died after using heparin made by Baxter. The active ingredient in heparin is made from the membrane of pig intestines. A plant in China called Changzhou SPL supplies Baxter with the active ingredient. The FDA, violating its own policy, failed to inspect the plant before it began shipping the ingredient to Baxter. The Chinese did not inspect the plant either.
When the FDA eventually inspected the plant it said that it found problems with cleanliness, quality control, and its equipment, and that the source of the pigs is questionable.
Although the FDA found problems with the Chinese plant, it says it does not know for sure what is causing the side effects.
Symptoms and Side Effects
Adverse reactions which have been reported have been primarily allergic-type reactions. Some are life-threatening. These reactions include:
- Nausea
- Vomiting
- Stomach pain or discomfort
- Diarrhea
- Difficulty breathing
- Shortness of breath
- Chest pain
- Rapid heart rate
- Low blood pressure
- Rapid drop in blood pressure
- Dizziness
- Fainting
- Unresponsiveness
- Excessive sweating
- Redness or paleness of skin
- Flushing
- Abnormal sensation of the skin, mouth, or lips
- Decreased skin sensitivity
- Burning sensation
- Watery eyes
- Thirst
- Throat swelling
- Difficulty opening the mouth
- Restlessness
- Feeling unwell
- Headache
- Drug ineffectiveness
Known Problems With Heparin
Heparin is known to have side effects; the most dangerous being heparin-induced thrombocytopenia (HIT), also called white clot disorder. HIT causes clotting and can lead to:
- Deep vein thrombosis
- Pulmonary embolism
- Skin lesions at injection sites
- Swelling
- Limb ischemia
- Gangrene
- Necrotic adrenal glands
- Organ failure
- Acute inflammatory responses
Prior Problems with Baxter
Heparin made by Baxter made headlines in 2007, after actor Dennis Quaid’s twin newborns were given 1,000 times the appropriate dose of the drug twice in one day, due to poor labeling of the vials used to package the drugs.
If you or a loved one has experienced heparin side effects, contact an experienced pharmaceutical injury attorney today.
