Plavix Internal Bleeding Lawsuit

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Plavix (clopidogrel) is a prescription medication designed to prevent unwanted blood clotting in individuals who have had or are at risk for a heart attack or stroke. Unfortunately, in some cases this effect can be harmful and may actually prevent wounds from healing after surgery, leading to episodes of severe internal bleeding. Even minor internal bleeding injuries can end up being fatal if the problem is not treated in a timely manner.

Plavix Overview

Plavix was approved for sale on the U.S. market in 1997 for the prevention of blood clots in patients who have had a bleeding or hemorrhagic stroke or heart attack, including acute coronary syndrome or myocardial infarction, or in those diagnosed with peripheral arterial disease (PAD). When taken with aspirin, Plavix has also been used to treat patients who have been hospitalized with heart-related chest pain, or with a certain type of heart attack (non-Q-wave MI), a condition referred to as acute coronary syndrome (ACS).

Manufactured and marketed by a partnership between Sanofi-Aventis and Bristol-Myers Squibb, Plavix is an antiplatelet medication that works by preventing platelets in the blood from sticking together and forming clots. This is designed to protect you from a future heart attack or stroke.

Plavix & Internal Bleeding

For years, it was thought that Plavix would cause less internal bleeding and other types of hemorrhaging than a similar drug called Warfarin. But a recent study conducted by the Centers for Disease Control and Prevention (CDC) found that the risk of internal hemorrhaging among Plavix-aspirin patients was substantially higher than originally expected.

While the CDC research did find that Warfarin was linked to a higher rate of bleeding than the Plavix-aspirin regimen, the combo therapy did much more poorly than expected. For both courses of treatment, the number of hospital admissions because of bleeding were statistically very similar. And bleeding-related emergency room visits were only 50% lower for those patients on the Plavix-aspirin regimen.

Another recent study published in the New England Journal of Medicine (NEJM) found that individuals taking Plavix were 12 times more likely than those taking aspirin and a heartburn drug to experience severe internal bleeding and chronic ulcers. The study also revealed that Plavix and aspirin combined offer no significant benefit compared to standard low-dose aspirin treatments.

To reduce the risk of internal bleeding, heartburn drugs like Prilosec, Nexium, Prevacid, Aciphex and Protonix are often prescribed to patients taking Plavix. But now it appears that patients cannot even rely on these medications to reduce the risk of Plavix internal bleeding. In November 2009, the FDA issued a press release warning the public that Prilosec could interfere with the body’s production of the liver enzyme CYP2C19. This enzyme is required to convert Plavix into its active form.

Signs & Symptoms of Internal Bleeding

Signs and symptoms of Plavix-induced internal bleeding depend on where the bleeding is located, how long the bleeding has been going on, and what body functions have been affected. Bleeding outside the circulatory system tends to be very irritating to the tissues, causing inflammation and pain. Examples of different types of internal bleeding include:

Intracranial bleeding – Occurring mainly due to trauma or from a leaking aneurism, intracranial bleeding may be accompanied by:

  • pain
  • confusion
  • weakness
  • slurred speech
  • loss of vision
  • coma

These symptoms depend upon where and how much blood is present in the patient’s brain. If left untreated, signs and symptoms become progressively easier to recognize.

Intra-abdominal bleeding – May be hidden and present only with pain, but if there is sufficient blood loss, the patient may experience:

  • weakness
  • lightheadedness
  • shortness of breath
  • shock
  • decreased blood pressure

Gastrointestinal bleeding – Patient may vomit bright red blood. If it has been in the stomach for a prolonged period of time, the vomit may look like coffee grounds. Bowel movements may be bloody or black and tarry, depending on the location of the bleeding in the gastrointestinal tract.

Plavix Injuries

In addition to the risk of internal bleeding, Plavix has also been linked to the following types of injuries:

  • gastrointestinal bleeding
  • cerebral bleeding or hemorrhage
  • thrombotic thrombocytopenic purpura (TTP)
  • bone marrow damage
  • heart attack
  • stroke
  • ulcers
  • death
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