Plavix is a brand name drug that was developed by Bristol-Myers Squibb and that is known by the generic name clopidogrel. This is a drug known as an antiplatelet medication, which means that it prevents the formation of blood clots by preventing platelets in the blood from sticking together. It was first approved by the U.S. Food and Drug Administration (FDA) in 1997 and the patent has since run out, meaning that generic versions are available.
Clopidogrel was a huge hit for Bristol-Myers Squibb, partly because the company marketed it so heavily in the late 1990s. That may prove to be a big problem for the company now as evidence is coming to light that this risky drug, which can cause fatal bleeding, may not be any better at preventing deaths from blood clots than the much cheaper and safer over-the-counter drug aspirin.
What is Plavix?
Plavix is the generic drug clopidogrel, an antiplatelet drug that prevents clot formation in certain patients. The main goal of using this drug in patients is to prevent heart attacks and strokes, and thereby to prevent deaths. Plavix is essentially a blood thinner, although it works in a different way than other blood thinners, like warfarin, Eliquis, or Pradaxa. Similarly to other blood thinners, though, Plavix carries the risk of dangerous bleeding. There is no antidote for Plavix, so excessive bleeding is a major concern.
Uses and How It Works
Clopidogrel works to prevent clots in patients by preventing platelets from sticking to each other. This is called platelet aggregation and is one way in which clots form in the bloodstream. To prevent platelets from aggregating, Plavix inhibits certain receptors on their membranes. This inhibition is irreversible and lasts as long as an individual platelet lasts. This means there is no antidote to reverse the action of Plavix once it starts working.
Plavix is often prescribed to be used in conjunction with aspirin, which also has blood thinner properties, but it may also be used alone. The FDA approved the use of Plavix for preventing heart attacks and strokes in patients with certain conditions. For instance, someone who has already had a stroke, a heart attack, or severe chest pains may be prescribed Plavix to prevent future episodes. Patients who underwent certain types of heart surgery may also use Plavix. Peripheral artery disease, characterized by poor circulation, may also be treated with Plavix to prevent life-threatening complications.
Some of the reported side effects of using clopidogrel are not considered very serious. These include stomach pain, nosebleeds, diarrhea, headaches, shortness of breath, nausea, vomiting, dizziness, and tiredness. If they do become severe or persist, these side effects may indicate that something more serious is going on and they should be reported to a doctor.
Some of these side effects, like the purple or red spots, may be signs of a rare condition called thrombotic thrombocytopenic purpura, or TTP. This occurs when small clots form in small blood vessels throughout the body. This condition can be serious for a couple of reasons. One is that the multiple clots can restrict blood flow to other parts of the body, causing major problems.
Another issue of TTP is that the numerous small clots that form involve platelets, the result being that blood in the rest of the body has low platelet levels. This means that excessive bleeding becomes more of a risk. Internal bleeding or cuts and external wounds can become dangerous because of the low platelet levels.
Serious Risks of Plavix
The most serious potential side effect of Plavix is the risk of bleeding, as is the case with most blood thinners. This is especially a risk with Plavix because there is no antidote to reverse the drug’s action. If bleeding starts, it can be very hard to stop and bleeding to death is possible. Signs of dangerous bleeding may include blood in the stool, urine, or vomit, bruising and patches of blood under the skin, a sudden, severe headache, mouth ulcers, excessive nosebleeds, and any other type of unusual bleeding.
The risk of bleeding becomes greater for anyone using clopidogrel along with other medications that also cause bleeding. These may include non-steroidal anti-inflammatory drugs like ibuprofen, aspirin, and other prescription blood thinners, like warfarin.
Another serious risk of Plavix is included in a black box warning on the packaging. It states that Plavix may not be effective in some patients because of genetic factors. The effectiveness of the drug depends on how it is metabolized in the body. Some people are poor metabolizers of the compound and are at risk for clots and adverse events simply because the drug is not effective for them. Doctors are urged to give patients a genetic test before prescribing Plavix.
Controversies over Effectiveness
Plavix is often prescribed along with aspirin to increase the effectiveness of preventing blood clots. This is dangerous because the combination of the two drugs increases the risk of excessive and life-threatening bleeding. Research from the last few years determined that this combination of Plavix and aspirin was not more effective than using aspirin alone and that Plavix used for 12 months or more along with aspirin was no more effective than using the combination for only six months.
This finding has been hugely controversial because it means that a lot of patients were put at risk for serious bleeding with no real improvements in death rates from blood clots. The FDA made this safety announcement in 2015 and stated that a final review of the data made it clear that “long-term use of the blood-thinning drug Plavix does not increase or decrease overall risk of death in patients with, or at risk for, heart disease.”
Because the latest information finds that patients may have been put at risk for serious side effects of Plavix in combination with aspirin, lawsuits have been started by individuals, as class actions, and by some states. People who used this combination therapy, now known to be no more effective than aspirin are accusing Bristol-Myers Squibb of producing a defective drug, of promoting a drug when there were safer alternatives, for promoting a drug for unsuitable uses, and for the fact that the side effects outweigh the benefits of using Plavix.
Some people died while taking Plavix and their loved ones are bringing suits against Bristol-Myers Squibb over these losses. Whether it was you or a loved one who suffered because of treatment with Plavix, you may be prepared to start a lawsuit as well. A lawsuit may provide compensation that can cover medical expenses, lost wages, funeral expenses, and pain and suffering.