FDA Black Box Warning for Plavix: What This Means
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FDA Black Box Warning for Plavix: What This Means

This article was written as a response to the question:
What the FDA black box warning for Plavix means.

The U. S. Food and Drug Administration issued a black box warning for Plavix (generic name Clopidogrel). What does this warning indicate? Is there something serious associated with the use of Plavix? Does Plavix interact with other drugs?

What A Black Box Warning Means

A black box warning (also black label warning or boxed warning) is the U. S. Food and Drug Administration’s (FDA’s) strongest warning to users. This means that the drug on a black box warning is found can have potentially dangerous side effects. A black border surrounds the text which is why it is named so.

Why The Warning

Why did the FDA issue a black box warning for Plavix? The reason is that there are heart disease patients who have difficulty metabolizing the drug. The difficulty in drug metabolism is associated with mutation in the so-called CYP2C19 gene. Approximately 2 to 14 percent of Plavix users don’t respond well to the drug and would be better off with alternative treatment. Screening for Plavix metabolism would therefore require tests to be made.

The inability to metabolize the drug increases the patient’s risk for heart attack and stroke. This is not because the drug will intoxicate or have harmful effects to them but that the drug will not provide any benefit for them at all. Increasing the dosage, however, may work.

Heart Attack

Image Source

Drug metabolism among patients vary across the human population. If the a patient with heart disease is able to metabolize the drug, the blood-thinning benefit of Plavix can prevent heart attack, stroke and other serious heart problems. Plavix keeps the blood from coagulating or clotting to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

This means, therefore, that if a heart attack susceptible patient happens to sustain even a minor injury, bleeding will occur. It is easier to detect external bleeding but if someone with heart disease has stomach or intestinal bleeding, this will require consulting a doctor. Indications of internal bleeding are black or bloody stools, blood is coughed up, or vomit is something dark.

Alcohol and Drugs Should Not Be Taken With Plavix

Drinking alcoholic drinks while taking Plavix may increase risk of bleeding in the stomach or intestines. Further, non-steroidal anti-inflammatory drugs (NSAIDs) should not be taken with Plavix. Examples of NSAIDs are the following (generic and brand names, respectively):

1. Aspirin,

2. Diclofenac (Voltaren),

3. Diflunisal (Dolobid),

4. Etodolac (Lodine)

5. Flurbiprofen (Ansaid)

6. Ibuprofen (Motrin, Advil)

7. Indomethacin (Indocin),

8. Ketoprofen (Orudis),

9. Ketorolac (Toradol),

10. Mefenamic acid (Ponstel),

11. Meloxicam (Mobic),

12. Nabumetone (Relafen),

13. Naproxen (Aleve, Naprosyn),

14. Piroxicam (Feldene), among others.

Considering that there is a long list of drugs that may have unwanted interaction with Plavix, it is wise to consult a doctor before taking the drug Plavix. There are tests to determine if the patient is not able to metabolize the drug into its active form. These tests, however, are costly. Such tests can cost around $500.

References

Cerner Multum, Inc., 2009. Plavix. Retrieved on April 23, 2010 at http://www.drugs.com/plavix.html#ixzz0lvOkEaly.

Lakhman, K., 2010. FDA’s new Plavix black-box warning could trigger surge in CYP2C19 testing. Retrieved on April 23, 2010 at http://www.genomeweb.com/blog/fdas-new-plavix-black-box-warning-could-trigger-surge-cyp2c19-testing.

Rockoff, J. D., 2010. A black-box warning for Plavix. Confusion may follow. Retrieved on April 23, 2010 at http://blogs.wsj.com/health/2010/03/12/a-black-box-warning-for-plavix-confusion-may-follow/tab/article/.

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Comments (3)

Sounds like some very serious side effects with this drug.I would not like to have to take it! Great article Patrick, well reseached and very informative!

Thanks Tanya. This drug is a big earner. That means many people use it, but they have to note the risk.

informative article. I had never heard of the black box...well only the one on a plane, which is what I thought this article was about. So I was in for a shock when I started reading. Great information Patrick.

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