Plavix, the generic drug clopidogrel, is made by Bristol-Myers Squibb and is available now as the brand name and through other manufacturers as a generic since the patent ran out. It is used as an antiplatelet medication to reduce the incidence of death from heart attack or stroke in people with certain conditions that make them vulnerable to developing life-threatening blood clots.

Although it was developed to save lives there are some very serious Plavix side effects, and one in particular, that makes this drug both risky and controversial. As a drug that prevents clot formation in the blood, it puts patients at risk for serious bleeding. This is a potentially deadly side effect that has led to deaths. Furthermore, this side effect has led to lawsuits because of how Plavix is used in combination with aspirin, another blood thinner, and recent research that indicates it may not be as effective as Bristol-Myers Squibb claimed it was.

Plavix and Its Uses

Clopidogrel is an antiplatelet drug. Platelets are small particles in the blood that clump together, or aggregate, to form clots, such as when there is bleeding that needs to be stopped. As an antiplatelet, Plavix prevents the platelets from sticking together. This prevents the formation of clots. It is a blood thinner, but acts differently to prevent clots than others in the class of drugs. Unlike these other drugs, there is no antidote for Plavix. Once it inactivates the ability of a platelet to clump, it is permanent until the platelet is recycled.

The U.S. Food and Drug Administration (FDA) approved Plavix for some specific uses in 1997. The general use is that it prevents deaths by preventing blood clots that cause heart attacks and stroke. The approval of the drug, however, is only for people prone to clot formation because of certain specific health conditions.

These include people who have already had a heart attack or stroke or who has severe chest pains. These people are prone to forming blood clots and having a recurrence. Plavix may also be used in people with peripheral artery disease because the antiplatelet action helps improve poor blood circulation. Finally, patients undergoing angioplasty surgery with or without a stent insertion and coronary artery bypass grafting surgery may also be given Plavix to prevent clots.

Mild Side Effects

Plavix side effects range from mild to life-threatening. Some are common, while others are rare. Users of the drug have reported having shortness of breath, headaches, stomach pains, nausea, vomiting, diarrhea, dizziness, lightheadedness, and fatigue or weakness. For most patients these more common side effects are not concerning, but they can be if they persist over a long period of time or become more severe.

Thrombotic Thrombocytopenic Purpura

A very rare, but potentially serious side effect of Plavix is a condition called thrombotic thrombocytopenic purpura, or TTP. This condition occurs when multiple small clots form in smaller blood vessels resulting in poor flow of blood as well as a low platelet count in the blood. If not recognized and treated this condition can be fatal because of the low level of platelets. This puts a patient at risk for dangerous bleeding.

The signs of TTP include fatigue and weakness, headaches, fever, a fast heart rate, pale or yellowish skin, confusion, and shortness of breath. There may also be bleeding under the skin or in the mucus membranes, which may look like small red or purple spots all over the body.

Excessive Bleeding

By far the most dangerous side effect of Plavix is bleeding and it is not that uncommon. Plavix is taken along with aspirin, which also has blood thinning effects and adds to the risk that a patient will bleed to a dangerous degree. The fact that the effect of Plavix is not reversible adds even more risk and increases the risk of patients actually dying from excessive bleeding.

Patients who use Plavix should be aware of the signs of unusual bleeding, which include any kind of bleeding that seems excessive or unusual. Signs of bleeding are tarry and bloody stool, blood in the urine, blood in vomit or vomit that resembles coffee grounds, unusual or deep bruising, blood pooling under the skin, mouth ulcers, sudden severe headaches, and excessive or frequent nosebleeds.

Another risk of using Plavix is the opposite of excessive bleeding. For the drug to work, it has to be metabolized a certain way in the body. Some people, due to genetic factors, cannot metabolize it. For these people the drug won’t work and they will continue to be at risk for blood clots and deadly heart attacks and strokes.

The Bleeding Side Effect and Effectiveness

That bleeding is such a serious and dangerous potential side effect is just part of the problem with Plavix. Although the drug has been on the market since 1997, only recently information has come out to suggest that patients have been put at risk of bleeding unnecessarily. Part of what makes Plavix so risky when it comes to bleeding is that it is combined with aspirin. Research from several studies has shown that this combination is actually no more effective than using the drug alone, but did put people at risk for more bleeding.

The warning about this problem didn’t come from the FDA until 2015, nearly 20 years after it first approved Plavix. This means that many, many people were put at risk for life-threatening bleeding when there were safer alternatives available that were as or more effective in preventing blood clots. The warning from the FDA also stated that research showed long-term use of Plavix, for 12 months or more, was no more effective at preventing death than six months of use. More patients were put at risk and for longer periods of time.

Because of this terrible Plavix side effect and the newest research that has brought the question of effectiveness to light, Bristol-Myers Squibb has faced a number of lawsuits. There have been suits brought by the loved ones of people who died because of bleeding and cases brought by state governments all claiming that the drug maker misled the public regarding the safety and effectiveness of Plavix, that it marketed the drug unethically, and that it failed to warn patients and doctors of the risks.