FDA Reviewing Side Effects of Plavix with Prilosec and Other Drugs
Published: January 27th, 2009 • Comments: 25
The FDA has issued an Early Communication to notify healthcare providers that they are investigating the safety of Plavix and whether the drug may be less effective in patients who are also taking heartburn drugs like Prilosec to combat the gastrointestinal side effects of Plavix.
Plavix (clopidogrel bisulfate) is a popular blood-thinner sold by Sanofi-Aventis SA and Bristol-Myers Squibb Co., which is used to reduce the risk of dangerous blood clots that could cause heart attacks or strokes.
Nearly 25 million prescriptions for Plavix were written in the United States during 2007, and it generated global sales of $7.7 billion.
The FDA indicates that the drug’s makers have agreed to work with the agency to conduct additional studies to evaluate the effect of genetic factors and other drugs, such as heart burn medications like Prilosec OTC, on the effectiveness of Plavix.
Recent research has found that Plavix may be ineffective in as many as 30% of heart patients with certain genetic factors and the FDA indicates that some reports suggest the use of proton pump inhibitors (PPI), like Prilosec, to decrease stomach acid may also inhibit the operation of Plavix.
Prilosec and Plavix are often taken together, as the heartburn medication combats side effects of Plavix which can irritate the stomach and cause stomach ulcers.
While the FDA is obtaining and reviewing new information, which could take several months, the agency has recommended that doctors continue to prescribe and patients continue to take Plavix as directed. However, doctors have been asked to re-evaluate the need for patients to use Plavix with Prilosec OTC or other PPI drugs.
Other drugs that can be used to reduce stomach acid, such as H2 blockers like Zantac, Pepcid, Tagamet and Axid, or antacids to not appear to interfere with the antiplatelet activity of Plavix, according to the FDA.
An Early Communication from the FDA does not mean that the agency has concluded that there is a cause and effect relationship or whether any regulatory actions or warnings may be necessary.
Comment by Colleen on 11 February 2009:
I took Prilosec and had OD symptoms even though I was on a regular dose. I was on 20mg a day. Keep in mind after these symptoms I just got medicated for the symptoms. They kept upping the dose.
No one thought the medicine could do this. Now I have been off for 4 months and am still sick. My life has fallen apart. I was supposed to get married this summer.
I am 24 years old, and was healthy before all of this.
Symptoms were:
* confusion
* drowsiness
* blurred vision
* fast or pounding heartbeat
* nausea
* vomiting
* sweating
* flushing (feeling of warmth)
* full feeling in my head
* dry mouth, very thirsty
I also experienced:
* constipation
* dizziness
* tooth and gum decay and pain
* left upper back/shoulder pain
* severe stomach cramps
* rash
* itching all over my body, mainly chest and arms
* my feet and ankles were swollen
* difficulty breathing
* muscle spasms,
* tingling in my face, lips, and limbs
Comment by larry on 6 April 2009:
Collen Be very careful I developed a side effect from plavix called ttp, all the syptoms you described are syptoms of TTp , please make sure you fget a blood test done to check your platelets , good luck and god bless
Comment by gary on 5 May 2009:
I have 8 stents in my heart and was on plavex and prilosec since 2004. I had constant severe chest pain, dizziness and weakness for 5 years. I had 3 stents in 2004, 3 stents 6 months later, then 1 and 1 6 months apart. Every time i left the hospital they told me how great i was going to feel. Not even close. It was hell. Recently my wife and i saw a tv special on taking the 2 together and the danger involved. Since then i contacted my Dr. and all hell broke loose. Since i am no longer taking prilosec with the plavex all the chest pains and other sym toms are gone.
Comment by Dors on 14 May 2009:
I’m due to have Embolisation soon for a anyurism in my brain.I will be taking Plavix along with the Prilosec that I now take for heartburn.
Comment by andrew on 15 May 2009:
yes i have been on prilosec for about 8 or 9 years and i started having symptoms like dizzy ness ,tingling in face ,hands,and feet as well as nausea,it is been said that it blocks the absorbtion of b 12 among other side effects, if i dont get better i will contact a lawyer and follow with a lawsuit this drug is mis leading , as well as there patent that expired in 2001 and they complained about revenue loss since it is the most prescribed madicine,just wait there will be a class action suit against them and the will have to give up there millions of dollars to the public this is not over yet
Comment by denise on 26 June 2009:
i have been taking omerazole 20 mg twice a day for about 2yrs and before that i was diganose with gerd about tthree yrs before total of 5yrs and latley i started getting blurred vision,bleeding in stool more than 1 a week heavey at times.reported to doctor,diffculty breathing,spasm in stomach past ten,went to ER several times a times felt confusion where i didn’t know what to do first,know my heart is acting up had a heart catherlazion done and on 6 july 2009 having a ct scan done im kinda scared about all this,also have taken reglan ,lipitor,god no what else is on my percription drug sheet at pharmacy please can anyone help with concerns
Comment by Nancy on 18 July 2009:
If it’s true about the Prilosec and Plavix combo killing people why arent doctors telling thier patients about it? My doctor just “poo=pooed” it when I asked him!
Comment by larry on 6 August 2009:
Its amazing all these new medicines that are coming out have so many side effects, years ago this was unheard of, the big drug companys are pushing these drugs to the doctors like common drug dealers in the street, claiming the drugs work wonders, but yet they still kill and hurt people all for the glory of profit. You have to wonder what these doctors are getting out of it
Comment by Jay on 20 August 2009:
I have 7 stents in my in my heart. Installed 2004 to 2007. I started taking Prilosec in 1996 and Plavix in 2004. I never felt any bad effects of Plavix +Prilosec.
But last month my cardiologist told me not push our luck and replaced Plavix with Zantac. I am changing my eating habits to somehow manage with Zantac. For hearttburn/reflux Zantac is nowhere as effective as Prilosec. (Aug. 20, 2009)
Comment by Debra on 3 September 2009:
My husband has Coranary Arery Disease, he has had 3 angioplastys with 7 stents placed. He has been on plavix and prilosec since 2006.
A week ago he started having chest pain again. they performed angio plasty last night. He had a blood clot in the right coranay artery and a blockage 2 more stents were placed. The Dr. seems to think it was the combination of plavix and prilosec. Had he not had an emergency angioplasty done he could have died. If that clot had moved to his heart. He was taken off of the prilosec and put on pepcid instead. Be careful with the combination. Talk over your concerns with your cardiologist.
Comment by Janet on 5 September 2009:
My 88 year old mom has been taking plavix for years and years w/no side effects. In April, she was told she needed to start taking prilosec because she had a zenker’s pouch (in her esophogus), even though she has never had any heartburn. Well, 3 weeks ago she had a massive stroke (a “dry” stroke caused by blockage). Could the prilosec have made her plavix so much less effective that she had this stroke? She was in excellent health before the stroke — taking 3 classes a semester @ college, etc.
Comment by DAN on 16 October 2009:
I just had two medicated stents put in rca HEART dotor told me to take plavix with 325 mg asprin for one year for heart burn pepcid 20mg or zantac im taking pepcid . IF anyone reads this and has same stents and info on your care please respond on how you are doing. and GOD BLESS.
Comment by Charlotte on 9 November 2009:
I had a massive heart attach at 54 in 2006 and my life was saved within 30 mins by 3 stents even though I never had high blood pressure, a bad lipid profile, diabetes or other factors. Because of the emergency situation I could not be transported to a hospital for the medicated stents, but I do have the unmedicated stents. Before my heart attach I had been taken Prilosec OTC for my GERD with amazing success. Nothing gives me heartburn anymore. After hearing about this, and reading this FDA article, I’m quite nervous about continuing with Prilosec and will immediately switch to one of the recommended other antiacids remedies, hopefully it will work as well. Even after my cardiologist wanted to take me off Plavix we decided to keep me on the med due to discovery of PAD. After reading this article I feel now maybe my blurred vision, numbness in limbs and shoulder/neck pain maybe be elevated, we will see
Comment by Rebecca on 21 November 2009:
I had an angioplasty in 1990. I had no symptoms of heart problems until bad left arm pain. I tired statins for many years and found I had an allergic reaction to all of them. We moved to another state and my new cardiologist prescribed plavix. That was in the early 2000’s. Three years ago I was diagnosed with a hiatal hernia and acid reflux. My P.C. prescribed protonix, but it made me sick to my stomach. He then prescribed prilosec. It has been working very well for me. I do take the plavix early in the morning (with candied ginger to protect my stomach) and take the prilosec twelve hours later. My acid reflux is much, much better and the plavix seems to be doing it’s job. I am uncomfortable with this news about the two meds. not working well together. I’ll read everything I can get my hands on about it, but until I start having the problems described in this forum, I will continue what I am doing. I am very care ful about what I eat and drink and do everything I can to keep my heart healthy.
Comment by Val on 1 December 2009:
My Mom was on both Plavix and Prilosec for about 2 years. She woke up one day completely confused and basically just “not really there”. She was admitted into the ICU and passed 3 weeks later. They never figured out what happened to her and she was in one of the top 5 hospitals in the country. She tested fine for EVERYTHING. After reading this, i wonder if this was the reason. i wish i had an answer because it weighs on me everyday.
Comment by Roger on 8 December 2009:
I had a heart attack while taking Plavix & prilosec about 6 monthes after having been told my heart was fine where thay took the scope test looking at heart ect this was after having like a 80% blockage in my left carotid artery and haveing a carotid endarterectomy.
Comment by Lorraine on 27 December 2009:
My mother-in-law just passed away after a sudden onset of chest pain diagnosed as a ruptured hiatal hernia( she did not survive the surgery to repair this). She had a history of surgery for the hiatal hernia over 10 years ago and had no recent symptoms of GERD, but had been switched from coumadin to Plavix over 6 months ago (she also had a pacemaker placement about 3 years ago).
I dont think she was on anything for GERD.
The surgeon who tried to do the the repair of her acute ruptured hiatal hernia said her “stomach was a mess” I’m wondering if she should had been on therapy with a PPI or at least have been followed for her GERD/hiatal hernia condition.
She had been in nursing homes for past 2-3 years and it seemed that her medical records had not followed her and her long-standing medical history was ignored by nursing home physicians. In fact, she went from the nursing home to the ER twice and the 2nd time if her son had not insisted they provided a diagnosis he wouldn’t allow her to be sent back to the nursing home. It was at this time he had to tell the ER staff to check her records from the nursing home for history of GERD surgery. Only then did they do the scan that gave her fatal diagnosis.
Comment by Tom on 10 January 2010:
My mom is on plavix and prilosec. She just had to have 2 stents inserted after throwing a clot into her arm. Lucky that it lodged there; she would be dead now I’m thinking if it went to her heart or brain. Her gird is terrible should she stop taking plavix?
Comment by Tom2 on 19 January 2010:
Unknowing, as I never thought it was an issue and never told my Cardio, I’ve been on Plavix and Prilosec OTC for several years ….years I’ve also gotten 4 stents and had two native grafts collapse. When I first heard about the possible conflict a few months ago, I stopped my prilosec. My Cardio always told me, “never miss a dose of Plavix.” Now my acid is so strong I choke when I eat. Until now I didn’t know that Zantac or Pepcid were good alternatives. I’ll start using them and let my cardio know on next visit. THANKS!
Comment by Tom on 27 January 2010:
I have three drug coated stents and was taking Plavix and Nexium.
I had no known side effects with either drug and was doing nicely.
My doctor took me off the Nexium and put me on Pepcid. the Pepcid is not doing the job. Not even close. My doctor told me to take double doses of Pepcid. I will try it, but am not very optimistic. I hope this helps someone.
Comment by james on 30 January 2010:
i have six stents snd have been on omerprazoile for over 3yrs 2x a day. with plavix.i am always having chest pains that nitro does not relieve. my dr keeps passing it off as not heart releated. ten weeks ago after a stress test i was admitted to hospital and had another stent implanted. never relieved my chest pains.
ten days after the stents i reaadmitted to hospitol after to days of testin i was released with no results for chest pains other than dont take omerprazoile and it resuced the effect of plavix by 25%. no mention of any side affects other than that. am home now with chest pains and confusion.
Comment by JULIUS on 1 February 2010:
Send info, I take both cut down to one omeprazole. Lots of gastric distress, since had none before.
Comment by Alan on 11 February 2010:
I am 36 years old and I just got home from the hospital due to having a heart attack. I have one stent, one artery completely blocked and one 60 percent blocked. I am not overweight, i exercise and eat fairly well. I have been taking prilosec for about 3 years now. Since, i have been put on plavix and have been taken off prilosec. Doctor has never explained why, so I have been doing research. My acid reflux has come back and I am needing an alternative, over the counter, prescription, or home remedy. Also wanted to know if pepcid, zantac, etc. was ok to take.
Comment by Melanie on 23 February 2010:
My father was recently prescribed Plavix in combination with aspirin after undergoing triple heart by-pass and heart valve replacement surgery. Two weeks post-op, he began feeling very weak and reported having dark, tarry stools.
Three weeks to the day after he was released after heart surgery, he was readmitted to the hospital with an extremely low blood count. He was hospitalized for two days and given 4 pints of blood. Still, his doctors were reluctant to replace this medication and insisted on performing more tests.
After reading about all the potential side effects of Plavix, we determined that a common sense course of action was for him to stop taking the drug and decline the additional tests, against the advice of his doctors.
All I can think is there must be some kind of kick-back scheme for doctors who prescribe this drug, since the benefits are dubious and the side-effects, such as intestinal bleeding, are potentially life threatening.
Comment by lori on 26 February 2010:
i am currently taking omeprazole for my stomach and i am having bad side effects and wanted to see if there is a class action lawsuit on this medication .