Heparin is a medication that’s been available for approximately 75 years, and its main function is to help prevent blood clotting during surgery. It’s manufactured by the Bayer Healthcare Corporation, and has been used in millions of surgeries of several types. It’s administered via injection prior to a surgical procedure.
Heparin is ordered by doctor in order to keep the clotting of blood to a minimum during surgery, as the clotting process can present significant problems to surgeons who are attempting to work on a particular area of the body. Heparin works by simultaneously boosting a naturally occurring anticoagulant molecule in the body that’s known as antithrombin III (AT-III) and inactivates the production of thrombin, which is one of the main components of the body-generated blood-clotting process.
The combination of these two functions stops the formation of fibrin, which by result stops the process of blood-clotting by the patient. Heparin accomplishes this in a foundational sense by attaching to the AT-III molecule and prompting the processes mentioned above. Therefore, the risk of clotting blood around the surgical incision is substantially reduced.
Heparin has been approved for general use and has been used both for the anticoagulant benefits described above during surgery as well as for use in the treatment of such conditions as deep venous thrombosis in a post-operative sense. Heparin has also been used for its main benefits during a blood transfusion. Heparin was originally discovered as a potential medical benefit in 1916, passed through several trials in the 1930’s and was ultimately approved for use in 1937.
Generally, when a drug encounters problems with side effects, these issues will generally arise within the first few years of its use on the market. However, Heparin was available for decades before negative reports of the development of side effects began to surface. The first set of negative reports that generated negative attention in regards to Heparin began to surface in 2007, and these side effects were very serious in nature.
In response to these negative reports, investigations revealed that the problem was centered on the lab in which Heparin was manufactured. As it turned out, Baxter had outsourced the production of Heparin to a lab in China. Given the reality that the location of this lab was outside the jurisdictional reach of the federal government, the scope of the investigation was limited to the analysis of samples of Heparin.
Ultimately, investigators concluded that the side effects that developed in patients were the result of the presence of contaminants in batches of Heparin that set off dangerous allergic reactions in more than 300 people. These reactions generated the following side effects:
- Dangerous drops in blood pressure
- Breathing difficulties
In addition to the reports of 300 people developing any combination of the side effects listed above, it was revealed that at least four people had died as a result of a Heparin injection.
When an investigatory entity is as limited as the FDA was in regards to this specific issue, its options are extremely limited. Given the laboratory’s location, there was no way that the specific problem with the presence of contaminants could be closely analyzed and corrected, which meant that the government only had one option in terms of dealing with the issue as soon as possible. That option was an order to halt the sales of Heparin, which is exactly what the government did.
Baxter Healthcare complied with that order and also announced a recall of several lots of the drug. While the continued sale of Heparin has not been ruled out in the future, the drug’s status as approved must be regained after the completion of an exhaustive and meticulous investigation that pinpoints the cause or causes of the issue and Baxter Healthcare can show that these problems have been corrected.
Given its time on the market, there have been several situations identified where Heparin should either not be used or only used with a high degree of caution. These include instances where the patient:
- Is bleeding heavily, unless in life-threatening situations
- Has displayed any hypersensitivity to Heparin in the past
- If the patient has any sort of liver disease
- During menstruation
Should I ask my doctor if he or she uses Heparin before surgery?
If you’re getting ready for surgery, you should ask that question, but it’s highly unlikely that your medical care providers will use Heparin given the status of the drug. However, it’s always better to err on the side of asking too many questions.
Can I file a lawsuit if I have suffered damages from taking Heparin?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Heparin, you should contact your doctor immediately. You may also wish to contact an experienced Heparin lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.