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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.


soundoff (1,596 Responses)
  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
    • Jojo

      I think it is so scarry to beielve that moms and aunts and femal baby sitters are potentially dangerous that we do everything we can to shut out the information.Women have most of the access to children, and we like to think that they are all safe. It makes us feel better to do so, it is comfortable.But obviously, all women are not safe. And that is frightening. My daughter was harmed by a woman therapist. My father abused by a woman teacher for two years. We need to toughen up and face facts, that abuse is a human problem, not a male one.Trey

      September 13, 2012 at 22:51 | Report abuse |
  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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  10. ricardo

    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.

    January 1, 2011 at 19:42 | Report abuse | Reply
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    Когда ΠΎΠ±Ρ‹Ρ‡Π½Ρ‹ΠΉ Ρ‡Π΅Π»ΠΎΠ²Π΅ΠΊ сталкиваСтся с Ρ‚Π΅ΠΌ Ρ‡Ρ‚ΠΎ потСрял ΠΊΠ»ΡŽΡ‡ΠΈ ΠΈΠ»ΠΈ Π·Π°ΠΌΠΎΠΊ Π±Ρ‹Π» случайно ΠΈΠ»ΠΈ ΡƒΠΌΡ‹ΡˆΠ»Π΅Π½Π½ΠΎ Π²Ρ‹Π²Π΅Π΄Π΅Π½ ΠΈΠ· строя ΠΌΡ‹ Π³ΠΎΡ‚ΠΎΠ²Ρ‹ ΠΏΡ€ΠΈΠΉΡ‚ΠΈ Π½Π° ΠΏΠΎΠΌΠΎΡ‰ΡŒ ΠΈ Π²ΡΠΊΡ€Ρ‹Ρ‚ΡŒ ваш Π·Π°ΠΌΠΎΠΊ. ВскрытиС Π·Π°ΠΌΠΊΠΎΠ² ΠΌΠΎΠΆΠ΅Ρ‚ ΠΏΡ€ΠΎΠΈΡΡ…ΠΎΠ΄ΠΈΡ‚ΡŒ ΠΊΠ°ΠΊ с ΠΏΠΎΠΌΠΎΡ‰ΡŒΡŽ слСсарного инструмСнта, Ρ‚Π°ΠΊ ΠΈ ΠΏΡ€ΠΎΡ„Π΅ΡΡΠΈΠΎΠ½Π°Π»ΡŒΠ½Ρ‹Ρ… ΠΎΡ‚ΠΌΡ‹Ρ‡Π΅ΠΊ – это зависит ΠΎΡ‚ Ρ‚ΠΈΠΏΠ° Π·Π°ΠΌΠΊΠ°, Π΅Π³ΠΎ ΠΌΠΎΠ΄Π΅Π»ΠΈ ΠΈ ΠΊΠ°ΠΆΠ΄Ρ‹ΠΉ наш мастСр Π·Π½Π°Π΅Ρ‚ ΠΊΠ°ΠΊ Ρ€Π°Π±ΠΎΡ‚Π°Ρ‚ΡŒ с Ρ‚Π΅ΠΌ ΠΈΠ»ΠΈ ΠΈΠ½Ρ‹ΠΌ Π²ΠΈΠ΄ΠΎΠΌ Π·Π°ΠΌΠΊΠ°. ВсС Ρ‡Ρ‚ΠΎ Π²Π°ΠΌ Π½ΡƒΠΆΠ½ΠΎ ΡΠ΄Π΅Π»Π°Ρ‚ΡŒ – это ΠΎΡ„ΠΎΡ€ΠΌΠΈΡ‚ΡŒ Π²Ρ‹Π·ΠΎΠ² ΠΈ ΠΏΠΎΠ΄ΠΎΠΆΠ΄Π°Ρ‚ΡŒ Π½Π΅ΠΊΠΎΡ‚ΠΎΡ€ΠΎΠ΅ врСмя прибытия мастСра ΠΏΠΎ Π·Π°ΠΌΠΊΠ°ΠΌ. ΠœΠ°ΡΡ‚Π΅Ρ€ ΠΏΠΎΠ΅Π΄Π΅Ρ‚ ΠΊ Π²Π°ΠΌ ΠΎΠ±ΡΠ·Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎ, Π² ΠΊΠ°ΠΆΠ΄ΠΎΠΌ Ρ€Π°ΠΉΠΎΠ½Π΅ ΠœΠΎΡΠΊΠ²Ρ‹ Ρ€Π°Π±ΠΎΡ‚Π°Π΅Ρ‚ ΠΏΠΎ нСсколько мастСров ΠΏΠΎ Π²ΡΠΊΡ€Ρ‹Ρ‚ΠΈΡŽ Π·Π°ΠΌΠΊΠΎΠ² ΠΎΡ‚ нашСй ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΈ. ПослС вскрытия Π·Π°ΠΌΠΊΠ° ΠΌΡ‹ ΠΏΠΎΠΌΠΎΠΆΠ΅ΠΌ Π²Π°ΠΌ Π² Π·Π°ΠΊΡƒΠΏΠΊΠ΅ ΠΊΠΎΠΌΠΏΠ»Π΅ΠΊΡ‚ΡƒΡŽΡ‰ΠΈΡ… ΠΈ установкС Π½ΠΎΠ²ΠΎΠ³ΠΎ Π±ΠΎΠ»Π΅Π΅ Π½Π°Π΄Π΅ΠΆΠ½ΠΎΠ³ΠΎ Π·Π°ΠΌΠΊΠ° для вашСй Π΄Π²Π΅Ρ€ΠΈ.

    слуТба ΠΏΠΎ Ρ€Π΅ΠΌΠΎΠ½Ρ‚Ρƒ Π·Π°ΠΌΠΊΠ° Π² Π΄Π²Π΅Ρ€ΠΈ

    November 26, 2020 at 11:14 | Report abuse | Reply
  40. promohabBom

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    November 26, 2020 at 12:41 | Report abuse | Reply
  41. djoxysceqf

    FDA issues new warning for Plavix – The Chart – CNN.com Blogs
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    November 26, 2020 at 21:42 | Report abuse | Reply
  42. Natatil

    Your money has arrived!!!
    Bitcoin turns lunch money into thousands >> http://freeforryou.blogspot.ie

    November 27, 2020 at 00:22 | Report abuse | Reply
  43. MDBsquacy

    ΠŸΡ€ΠΈΠ½ΡΠ»ΠΈ Ρ€Π΅ΡˆΠ΅Π½ΠΈΠ΅ ΠΏΡ€Π΅Ρ€Π²Π°Ρ‚ΡŒ Π±Π΅Ρ€Π΅ΠΌΠ΅Π½Π½ΠΎΡΡ‚ΡŒ? Если ΡƒΠ²Π΅Ρ€Π΅Π½Ρ‹ Π² Π½Π΅ΠΌ, Π·Π½Π°Ρ‡ΠΈΡ‚ ΠΈΡ‰ΠΈΡ‚Π΅ бСзопасный соврСмСнный Π²Π°Ρ€ΠΈΠ°Π½Ρ‚ – ΠΌΠ΅Π΄ΠΈΠΊΠ°ΠΌΠ΅Π½Ρ‚ΠΎΠ·Π½Ρ‹ΠΉ Π°Π±ΠΎΡ€Ρ‚ с сопровоТдСниСм Π³ΠΈΠ½Π΅ΠΊΠΎΠ»ΠΎΠ³Π°. На сайтС https://medabort.kiev.ua/ Π΅ΡΡ‚ΡŒ ΠΎΠ½Π»Π°ΠΉΠ½ тСст Π½Π° Π±Π΅Ρ€Π΅ΠΌΠ΅Π½Π½ΠΎΡΡ‚ΡŒ, ΠΎΠ½ послуТит подсказкой Ссли Π²Ρ‹ Π½Π΅ Π΄Π΅Π»Π°Π»ΠΈ тСст. Но наш Π³ΠΈΠ½Π΅ΠΊΠΎΠ»ΠΎΠ³ Ρ‚ΠΎΡ‡Π½ΠΎ ΠΎΠΏΡ€Π΅Π΄Π΅Π»ΠΈΡ‚, Π±Π΅Ρ€Π΅ΠΌΠ΅Π½Π½Ρ‹ Π»ΠΈ Π’Ρ‹, Π½ΠΈΠΊΡ‚ΠΎ Π½Π΅ ΡƒΠ·Π½Π°Π΅Ρ‚, ΠΊΡ€ΠΎΠΌΠ΅ Вас. Наша ΠΊΠ»ΠΈΠ½ΠΈΠΊΠ° ΠΈΠΌΠ΅Π΅Ρ‚ Π°ΠΊΡ€Π΅Π΄ΠΈΡ‚Π°Ρ†ΠΈΡŽ ΠΈ Π»ΠΈΡ†Π΅Π½Π·ΠΈΡŽ ΠΈ ΠΎΠ±ΠΎΡ€ΡƒΠ΄ΠΎΠ²Π°Π½Π½ΡƒΡŽ ΠΎΠΏΠ΅Ρ€Π°Ρ†ΠΈΠΎΠ½Π½ΡƒΡŽ. НС довСряйтС Π·Π΄ΠΎΡ€ΠΎΠ²ΡŒΠ΅, Ссли этого Π½Π΅Ρ‚. Π’Π΅ΠΌ Π±ΠΎΠ»Π΅Π΅ Π½Π° ΠΌΠ΅Π΄ΠΈΠΊΠ°ΠΌΠ΅Π½Ρ‚ΠΎΠ·Π½Ρ‹ΠΉ Π°Π±ΠΎΡ€Ρ‚ Ρ†Π΅Π½Π° Ρƒ нас Π±Π΅Π· скрытых Π΄ΠΎΠΏΠ»Π°Ρ‚, Π½Π΅ Π·Π°Π²Ρ‹ΡˆΠ΅Π½Π½Ρ‹Π΅. MedAbortHelp Π³Π°Ρ€Π°Π½Ρ‚ΠΈΡ€ΡƒΠ΅Ρ‚ ΠΏΡ€ΠΎΠ·Ρ€Π°Ρ‡Π½ΠΎΠΉ ΠΈ Π΅Π΄ΠΈΠ½ΠΎΠΉ Ρ†Π΅Π½Ρ‹ Π½Π° ΠΌΠ΅Π΄ΠΈΠΊΠ°ΠΌΠ΅Π½Ρ‚ΠΎΠ·Π½ΠΎΠ΅ ΠΏΡ€Π΅Ρ€Ρ‹Π²Π°Π½ΠΈΠ΅ бСрСмСнности Π² КиСвС. ΠœΡ‹ примСняСм Ρ‚Π°Π±Π»Π΅Ρ‚ΠΊΠΈ для прСрывания бСрСмСнности, ΠΎΠ΄ΠΎΠ±Ρ€Π΅Π½Π½Ρ‹Π΅ ΠœΠΈΠ½Π·Π΄Ρ€Π°Π²ΠΎΠΌ. Π’ ΠΏΠ°ΠΊΠ΅Ρ‚ ΠΌΠ΅Π΄ΠΈΠΊΠ°ΠΌΠ΅Π½Ρ‚ΠΎΠ·Π½Ρ‹ΠΉ Π°Π±ΠΎΡ€Ρ‚ входят Ρ‚Π°Π±Π»Π΅Ρ‚ΠΊΠΈ, Π°Π½Π°Π»ΠΈΠ·Ρ‹ ΠΈ ΠΌΠ°Π·ΠΊΠΈ, осмотр Π²Ρ€Π°Ρ‡Π° ΠΈ ΠΏΠΎΠ»Π½ΠΎΡ†Π΅Π½Π½Ρ‹ΠΉ ΠΊΠΎΠ½Ρ‚Ρ€ΠΎΠ»ΡŒ. ΠŸΠΎΠΌΠ½ΠΈΡ‚Π΅, Ρ‡Ρ‚ΠΎ ΠΌΠ΅Π΄ΠΈΠΊΠ°ΠΌΠ΅Π½Ρ‚ΠΎΠ·Π½Ρ‹ΠΉ Π°Π±ΠΎΡ€Ρ‚ допустимо ΠΏΡ€ΠΈΠΌΠ΅Π½ΡΡ‚ΡŒ ΠΏΡ€ΠΈ срокС Π΄ΠΎ 7 нСдСль. А Π²Π°ΠΊΡƒΡƒΠΌΠ½Ρ‹ΠΉ Π°Π±ΠΎΡ€Ρ‚, Ρ†Π΅Π½Π° Π½Π° ΠΊΠΎΡ‚ΠΎΡ€Ρ‹ΠΉ Π²Ρ‹ΡˆΠ΅, проводится ΠΏΡ€ΠΈ срокС бСрСмСнности ΠΏΠΎ Π£Π—Π˜ Π΄ΠΎ 12 нСдСль. Π­Ρ‚ΠΎΡ‚ способ Ρ‚Π°ΠΊΠΆΠ΅ Π±ΠΎΠ»Π΅Π΅ бСзопасный, Ρ‡Π΅ΠΌ хирургичСский Π°Π±ΠΎΡ€Ρ‚. Если ΠΌΠ΅Π΄ΠΈΠΊΠ°ΠΌΠ΅Π½Ρ‚ΠΎΠ·Π½Ρ‹ΠΉ Π°Π±ΠΎΡ€Ρ‚ позволяСт срок бСрСмСнности, Π·Π²ΠΎΠ½ΠΈΡ‚Π΅ сСйчас. ПомоТСм Π’Π°ΠΌ ΠΈ расскаТСм ΠΏΠΎΠ΄Ρ€ΠΎΠ±Π½Π΅Π΅. Π—Π²ΠΎΠ½ΠΈΡ‚Π΅!: (063) 978-89-44, (099) 298-75-05, (044) 360-83-83, (067) 756-88-66
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    November 27, 2020 at 04:08 | Report abuse | Reply
  44. DanielTet

    Б‑Р»Р¡РЅ

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    ΠšΠΎΡΠΌΠ΅Ρ‚ΠΈΡ‡Π΅ΡΠΊΠ°Ρ, Π²ΠΎΡΡΡ‚Π°Π½ΠΎΠ²ΠΈΡ‚Π΅Π»ΡŒΠ½Π°Ρ, комплСксноС нанСсСниС
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    November 27, 2020 at 08:33 | Report abuse | Reply
  45. DonmaK

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    November 27, 2020 at 14:54 | Report abuse | Reply
  46. Bsvxx

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    November 27, 2020 at 19:34 | Report abuse | Reply
  47. SmmDub

    ΠžΡ‚Π»ΠΎΠΆΠ΅Π½Π½Ρ‹ΠΉ постинг Π² инстаграм ΠΈ Π² ΠΎΡΡ‚Π°Π»ΡŒΠ½Ρ‹Π΅ соц сСти Pinterest ΠŸΡ€ΠΎΠΊΡΠΈ ΠΈ Π΄Ρ€ΡƒΠ³ΠΈΠ΅ ΠΌΠΎΡ‰Π½Ρ‹Π΅ инструмСнты

    November 27, 2020 at 21:08 | Report abuse | Reply
  48. geiqdzvpl

    FDA issues new warning for Plavix – The Chart – CNN.com Blogs
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    November 27, 2020 at 21:48 | Report abuse | Reply
  49. bpmdsytlo

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    November 27, 2020 at 22:53 | Report abuse | Reply
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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.