March 12th, 2010
05:12 PM ET

FDA issues new warning for Plavix

By Saundra Young
CNN Medical Senior Producer

A new boxed warning has been added to the anti-blood clotting drug Plavix by the Food and Drug Administration, who says the medication doesn't work well in people who have difficulty metabolizing the drug.

Plavix is used by patients with heart disease to help decrease risk of heart attack, stroke and death. It works on platelets–special blood cells that help blood clot to stop bleeding–by preventing blood clots from forming.

Plavix needs to be activated by the liver enzyme, CYP2C19. Patients that have reduced liver enzyme function can't activate the drug making it less effective for them. They're called "poor metabolizers" and this puts them at greater risk of heart attack, stroke and death.

"We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients," said Mary Ross Southworth, a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

The Agency says there are tests available to evaluate CYP2C19 and determine if you are a "poor metabolizer." They say patients should talk to their doctors to determine if they should stop taking the drug.

Last November the FDA issued a warning about using Plavix in conjunction with over the counter stomach acid reducer Prilosec and Prilosec OTC when new data found that taking the two together reducedPlavix's anti-clotting effect by about half. .

Plavix is available only by prescription. It's made by Bristol-Myer Squibb and Sanofi Aventis, who issued the following statement "The revisions to the prescribing information for Plavix reflect the companies' ongoing research in collaboration with the FDA, which better defines the patient population that may be affected by a genetic variation in CYP2C19 and alternate treatment strategies."

Editor's Note: Medical news is a popular but sensitive subject rooted in science. We receive many comments on this blog each day; not all are posted. Our hope is that much will be learned from the sharing of useful information and personal experiences based on the medical and health topics of the blog. We encourage you to focus your comments on those medical and health topics and we appreciate your input. Thank you for your participation.

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  1. Norman

    I was so happy to get off of that drug. Taking it with aspirin on Dr's orders. When you get cut, you bleed and bleed and bleed. I would also get nose bleeds, which I never have had not taking that medication.

    March 12, 2010 at 22:52 | Report abuse | Reply
  2. SeanP.

    Hi, I'm just curious about what the possible symptom's or side effect's are with someone that is taking plavix and can not metabolize it proper.
    The reason I'm asking is because my dad is on it and had been on it for almost 9 years now.

    March 13, 2010 at 21:13 | Report abuse | Reply
  3. Randy

    I'm on Plavix and aspirin as well, but 15 years post MI and open heart surgery plus two agioplasties and two stents, I'm alive and kicking and in the best health of my life. Sure I bleed a lot (I've ruined a lot of clothes from little scratchs and hangnails) but that's a small price to pay.

    March 15, 2010 at 09:27 | Report abuse | Reply
  4. Duane

    i had a heart attack ten years ago, since then I have been taking Plavix and aspirin, I do not like this medicine either, because of the excessive bruising and bleeding,even a minor cut can send me to a Doctor to control the bleeding. I have blood work done once a year to check liver function and cholesterol levels, would this test detect weather or not my liver was processing the drug? My tests have all been fine for liver function.

    March 15, 2010 at 09:29 | Report abuse | Reply
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  5. jason twombley

    As a former Plavix user due to a stroke, my Veterans Administration doctor switched me to a drug named Aggrenox (aspirin/extended-release dipyridamole) which seems to do the same thing as Plavix, with less risk. M y health seems to be the same, and my life activity hasnt suffered. I think the world of the Veterans Administration health care for keeping me alive.

    March 15, 2010 at 09:59 | Report abuse | Reply
  6. norma wallin

    My Mother is 91 yrs old and has been on plavix for about four years. Her skin is very thin, the plavix makes her body looked bruised and very bad. Would you advise me to talk to the doctor about the drug which Jason Twomley wrote in his comment. She also bleeds when gets cuts. Her skin is so thin the doctor told us to be careful not to grab her arms because the skin could tear.

    March 15, 2010 at 14:58 | Report abuse | Reply
  7. pharmd

    This new blackbox is not very useful clinically. I just don't see it ever happening where it becomes std of practice to order cyp isozyme evals for all patients.

    Plavix is a fantastic drug...yes, you will tend to bleed a little bit longer, but hey, it beats being on coumadin and getting lab work done monthly(or more) or being on aggrenox and facing ridiculous headaches....and in the case of all these drugs, you face increased bleeding risk anyways.

    March 17, 2010 at 03:10 | Report abuse | Reply
  8. Very Concerned

    I was recently told by a pharmacist that they would NOT put their spouse on Plavix (even though the spouse had a heart attack several years ago). Pharmacists know drugs. Doctor's often just prescribe and send you home. Is this a ambiguous drug with too many negative effects? Are their better options? Pharmacist recommends Vitamin E (at least 800IU). I had a TIA and can't get a clear perspective on this drug. Currently, Plavix lawsuits out there. It is now the second most prescribed drug on the market. Costly – no generic – big revenues for maker. Company did a little song and dance to renew patent on it. I would really like to know the truth about Plavix. I continue to ask doctors. Nothing but, "yes take it." I am allergic to aspirin.

    May 2, 2010 at 17:52 | Report abuse | Reply
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    wife had a stient and was put on plavix, which she was also taking prilosec. she said she felt 30yrs younger. within 2wks she got a rash on her lower body and not feeling as good as after the stient was put in. 4wks after stient she got a 3in blood clot at her stient and was in hospital 11wks, life support 3 times. doctor said it was due to the prilosec counteracting the plavix. she is waiting for a heart transplant now. I have read that the drug company that makes plavix knew about the problem. too late for my wife. the FDA has finally expressed a concern.

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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.