Bone Fracture Warning Added to Nexium, Prilosec, Other Hearburn Drugs

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The FDA is requiring that additional information be provided by several pharmaceutical companies about the risk of bone fractures from Nexium, Prilosec, Prevacid and other heart burn medications. 

In a drug safety communication released on May 25, the FDA announced that all proton pump inhibitors (PPIs) will now include a warning that they may increase the risk of fracturing bones in the hip, wrist, and spine. The labeling change came after FDA drug safety reviewers looked at a number of epidemiological studies into PPI bone fracture risks.

One such study, published earlier this month in the Archives of Internal Medicine, found that women who took PPIs were 25% more likely to suffer a Prilosec or Nexium bone fracture over an 8-year period than women who did not. The new labeling changes will indicate that the fracture risks appear to be linked to long-term use. FDA officials say that although the studies have looked at people who used the drug for more than a year, the drug facts section of the labels will indicate the possibility of risk after 14 days of continuous use.

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Drugs that will be affected by the labeling changes include the prescription drugs Nexium, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo. The labeling changes will also be applied to over-the-counter drugs including Prilosec OTC, Zegerid OTC, and Prevacid 24HR.

“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” said Dr. Joyce Korvick, FDA’s Division of Gastroenterology Products deputy director for safety. “Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”

The prescription drugs pull in about $14 billion in U.S. sales each year, and many are prescribed for indigestion and heart burn, although with the exception of Prilosec, they are only approved for treatment of ulcers, acid reflux disease and erosive esophagitis. There were about 119 million prescriptions for proton pump inhibitors in the U.S. last year. Some medical experts estimate that as many as 69% of proton pump inhibitor prescriptions were written for “off-label” uses, which have not been approved as safe and effective by the FDA.

Tags: Aciphex, Fractures, Hip Fracture, Nexium, Prevacid, Prilosec, Proton Pump Inhibitors, Protonix, Vimovo, Zegerid

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102 Comments

Lisa
So, I guess I am doomed. My “silent reflux” causes sinus infections and asthma. I get sick if I don’t take medicine for acid reflux. Even if I had surgery to correct the condition, the doctor said I’d have to take this medication. My wrist has broken. I bent over to pick something up, and a rib broke. No one would blame the Prilosec because I am an old lady now. They told me to take Fosamax…I’d never take that. I wonder if all my calcium and Vitamin D can hold this off.
Judy
I am A RN and have missed several months of work over the past 10 yrs. 6 yrs ago i experience a fracture of my right tibia, and this spring a fracture of my right wrist . I also have degenerative disk. What bone is next????
Ellis
I have been taking first Prilosec and then Nexium for over 15 years. In Dece 2006 I got out of bed and my right leg colapsed fracturing my hip. I had surgery which inserted three screws in my hip. For the next four months my hip did not mend and it was recommended that I have total hip replacement surgery. During pre op testing it was determined that I needed four way coronary bypass surgery (CABG). I had that surgery in May 2007. In August 2007 I had total hip replacement surgery. In July 2008 I had back surgery to fuse L5 and SI vertabrae. In August 2009 it was determined that I needed total hip replacement surgery on my left hip. this was performed in August 2009.
Judy
I have been on Nexium for about 2 yrs. I recently had a bone density scan which showed severe bone loss not only in several vertebrae but also in the pelvic region. Have worked in the medical field for many years yet my doctor never discussed any possibility of this risk. I am still relatively young (51) and was told I have the bones of an 80 yr. old woman. As a nurse I am very concerned of the type of tx. available , if any. Who will bear the financial responsibility for my care? Certainly not the pharmecutical co. who is making a fortune off my misfortune.
Worried Mom
My 9 year old son who has ALWAYS been very active and played baseball and football since he was 5 was prescribed Nexium 40mg every morning and Zantac 150mg every night. Right at his 6 month of taking them, he was running, typical and fell and broke his left wrist, both bones and received a frontal lobe concussion. Eight weeks later after getting cast off and the ok to play, he pitched an inning at a ballgame and did fine, the next inning he threw the ball and his right elbow popped. Fractured it. In May my husband seen something on t.v. about Nexium fractures and he stopped him from taking the meds. We are terrified now and he is fishing until we can make sure his bones are ok.
Dee
I was diagnosed approximately ten years ago. Nexium was the only thing that has really worked the best, but unfortunately I can’t afford $l75 price tag. I have been alternating between Zegerid, Prilosec, Prevacid and any generic depending on the price. I did have to have hip replacement surgery in 07 which left me with foot drop. I also have simliar leg issues going on the left side. My back always kills me and I see a chiropractor. I have terrible joint pain much of the time. After a bone scan, I found out that I am borderline for osteoporosis. I am taking calcium with d and glucosamine. I still need my meds. I die at night without them. Not sure what to do now.
Maureen
I was watching TV acouple of wks ago and an ad came up about people who take nexium are eligible for money from a lawsuit. I have taken Nexium since it was released in Canada and I like many are taking 2 tablets a day. In 1998 I fell and broke my rt wrist in 5 places, and have problems since. Then on Aug 3rd 2009 I fell in my driveway and fracture my elbow so severly that the North Bay General Hospital could not repair it. I was air lifted to Ottawa General where I was operated on and it took about 5 hrs and now I have a titanium elbow. I also had alot of problems with the surgery and my recovery. So is there a lawsuit and who do we contact?
Harold
In 2000 I was diagnosed with Acid Reflux. I was put on Prilosec and after three months the Doctor proformed a endoscope and put me on nexium 40 mg to be taken twice a day. I took It faithfully for three years, The cost was very straining on my bank account( over 180.00 a month) At this time there was no generic brand to sub for it. Started taking it sparingly for the next few years. Over the past few years I have noticed a weekness in my bones, constant back problem, some days it takes a good half hour just to walk upright, I have had my hip go out of joint numerous times and servre aches and pains in my hands, legs, and feet. I was crediting this to the fact that I am getting old, but after reading others stories I am not sure that these drugs are not the reason for my pain.
Heather
I was looking for an explaination for my broken ankle, it should only have been a bad sprain when i discovered all ofl these comments and thought of all the years i have been on Ne3xium and times when it was twice daily…Now i have answers for the other fractures and years of back arm shoulder and leg pain i have had for past 10 years. Thanks and may we all find some relief without side affects which are detrimental to our health and well being.
Jeff
I have been on 80 mg of prilosec for two years now and now I have multiple fractures in my spine and Hemangiomas of the spine and osteoporosis which is uncommon in a 43 year old male. I also live with CONSTANT aches during the day and awful Pain at night when I try to go to sleep. I have to take sleep aids and pain meds just to get a half way decent nights sleep.
Jeff
I have been on 80 mg of prilosec for two years now and now I have multiple fractures in my spine and Hemangiomas of the spine and osteoporosis which is uncommon in a 43 year old male.
Janet
I have been taking genetic Prilosec for about 1 year and out of the blue broke my ankle in 2 places.Dexxa scan indicates a reduction in bone density.I am not on this drug now-after the the fracture I stopped!
Jennifer
My 11 year old has been on prilosec for quite some time now. He has fractured 2 two bones in 9 months. I am shocked about the news!!!!!
Danniel
I have taken Prilosec 20 mg tabs since March 2007 and have experienced several bones fractures in my toes November 2009 and fingers May 2010. I have since had a bone density Dexxa scan indicating a reduction of bone density. Is the use of the Prilosec drug a contributing cause to this condition?
jack
i have been taking prilasec and aciphex for several years and i have had several fractures.ribs,foot.
Roger
I use to brag how I’ve never spent a day in the hospital in my life. I never broke a bone and still to this day not one cavity. I’ve always had strong bones and teeth. After taking Nexium and Prilosec for about 8 years or so now at 52-years-old I’ve lost two teeth that fractured in half, and fractured my L-5 vertabrae. All for no apparent reason. It amazed me how I could fracture my teeth and my vertabrae without having an event that would have explained it. I was off of work for 4 months. There is no doubt in my mind these PPIs caused this. The only positive thing that came out of all of this is that after being on antobiotics prior to back surgery it cured my stomach acid problem and no longer have to take this stuff.
Ricky
Durring activation for Desert Sheild/Storm 1990/91 and after wards I experienced Acid Reflux that was so bad It would take my breath away when the acis would get into the esopagus. After returning back to the states I started taking things such as Malox, Rolaids and the such, then one Drill weekend for reserves I got a pain in my chest and my Navy Cheif Corpsman thought I was having a hert attack, so they rushed me to emergency room and subsequently determined that I should have an endoscope that revealed severe GERD. I was placed on a diet of low fat foods no coffee, chocolate etc… I was also prescribed Prilosec two times daily. I adhered to this regimine for several years and each time I went without the prilosec I would experience the volcanic type reaction most people have when having an attack. So I stayed on my Prilosec and I thought it was a life saver, then because of my age my new Dr. ecides when I turned 50 to have me do another endoscopy which revealed Barretts esopogus, and I was to maintain the same regimine of twice daily Prilosec, and wath my diet, I subsequenly was diagnosed with Asthma, and coughed all the time, well this year I was diagnosed with Osteoporisis, and through my investigations I found that with a person taking medications such as omeprazole that people could develope this condition, I also came down with bacterial conditions that medications hardly are effective at all. I Got Bronchitis and coughed so hard I fractured a couple of ribs in the process.
David
I have had to have 7 discs fuzed together. My bones are “soft”. I have DDD. I have taken these meds for about 12 years. I would love to hear of a class action lawsuit due to these companies not saying anything about these effects. I am only 43 and I was informed I can never do my occupation again. I have 19 years invested in my career. What am I supposed to do now???
Janet
I started with Nexium several years ago but it stopped working for me so now am taking Protonix. During the time I was on the Nexium I had a fall and shattered my shoulder ball joint, had that surgically mended. Now I have been on the Protonix for at least two years and have aching hips, both shoulders are sore, degenrative bone soreness in both thumbs and very painful knees. Since I have suffered from acid reflux for many years and had never found anything that relieved it other than the meds stated, I am wondering what I can do because if I cease the meds the acid reflux returns and if I continue taking them the bone problems will more than likely get worse, this puts me in between a rock and a hard place, damned if you do and damned if you don’t I am 60 years old and at an age where bone loss could be an issue without the aid of meds that cause it. Lovely!!!
Susan
My husband has been taking Tagamet for 4 yrs. now after having his gallbladder removed. The surgeon (in another city) told him to take Protonix for 3 months, then quit. His dr. where we live said “well, you need to take Tagamet 300 from now on”—he has and recently broke a bone in his foot and hasn’t a clue as to how he did it. He quit Tagamet (which may not be as bad as the others mentioned here) today. THANKS FOR THIS INFO!! Oh, and I supposedly have osteoporis but refuse to take ANY of those drugs b/c I suspected they were dangerous, and now we see they cause you to break your tibia or thigh. Ladies, all of those Dexa machines are calabrated differently, and my 38 yr. old daughter was told she had osteoporosis, but DOES NOT! Don’t believe everything your dr. tells you!
carol
I have been taking Nexium for at least 8 years if not longer. I had a hip fracture in 2008, that required 2 surgeries and log recover periods (screws and rod put in my hip and thigh). I was only 47 years old. Then in June 2009 I suffered a femur fracture. Another surgery. I am still recovering from these fractures and unable to work. I certain am happy to discover the reason why these fractures occurred. But I would be even happier if I could recover the 2 1/2 years of income lost as well.
Rita
I have severe GERD, was feed by feeding the whole year of 2007, I have been on Nexum since 2007. I just got out of the fracture bone cast.I had 3 fractures in my right for no known reason.
betty
i was put on prilocet for larengel reflux i switched to over the counter omeprazole DR 20mgm an i took 2 tabs a day i fx my rt wrist both bones in august from a fall then in nov, i steped down from a chair as i was hanging christmas lights fx my left wrist then in feb i knocked the iron off an fx my rt foot i wonder could these fx be the results of this med. or just because i am clumbsy betty
sandy
just read the article,after hearing a warning about nexium,I will be stopping nexium immediatly. Iam taking nexium for a small ulcer which is healed now Iif it comes back oh well rather live with a ulcer the broken bones.Thanks for a very informitive article,will be stopping nexium immediatly
Matthew
I have been taking prilosec for approx. ten years. I have been diagnosed with osteoporosis due to lack of calcium from taking priolosec. I am 41 and in the last 6 yrs broke my femur,tibia,ulna and my foot. I have had bad back pain for several years.
Homer
I have been taking prilosec for 6-7 years. I have never broken a bone but I have noticed my bones are stiff at night when I go to bed. I “pop” my ankles, knees and back every night before I can go to sleep. I just thought I was getting old ( 53) but now I realize this started after taking drug. I don’t think I can live without it but I have been trying to take it every other day. I wonder if these drug companies are paying the FDA to approve drugs before they are proven safe and why didn’t the drug companies warn us before now!!!!
grandpa jose
i started taking PPI after i had a 6- bypas -heart surgery in 1998. my dr. prescribed me several of these ppi’s one after the other;from prilosec to protonix to nexium to zenegrid and presently to prilosec. i used nexium more or less for 7 years. i’ve been in pain for years; from lower back, to shoulder, hip, spine, wrists,knees, ankles, but worst of all my BRAIN is in pain now because my doctors keep on telling me ” the pains go with aging”, i used to like long -walk exercise for more than 1 hr and treadmill for 30 min everyday but currently i couldn’t do this anymore and because of not doing my exercise my blood sugar is starting to rise. i don’t have arthritis and i’m not obese and not diabetic and i am positive the pain from my hips, knees, wrists, ankles are due to the side effects of these PPIs.
michelle
Ive been on prilosec for 4 years and has had 4 fractures in the left leg and 3 possibly 4 in the right leg. Never broke a bone before this.I cant work or walk around for more the 3 hours. It is the worst pain when it comes from the bones
Maggie
I have been on nexium for over two years and all of a sudden my teeth are disappearing and Im facing very expensive dental work to even try and save what i have left. Never once did anyone including my doctor advise me that the medication could cause this and if i had any idea i wouldnt have started taking it. My teeth are gone they are over half their size and i cant even talk right , hard to eat and if you look at my teeth you can see the nerve at the top of many teeth. Im so upset finding out just today that it wasnt my acid reflux ity was the medication all along!
Gerry
Been on ppi’s for approximately 10 yrs. These drugs long term can cause decalcification of bones ie. hips and spine. Suggest you try to reduce there use by supplementing zantac in pm with lower dose of nexium or prilosac. Zantac doesn’t cause the same degree of decalcification. I too, am working on this readjustment. Its not easy because I’ve gone from sympton free to acid reflux in just a few days.
Sabrina
I could not believe the television ad when I say it concerning nexium and the other medications for GERD. I have been having problems with my wrist and hip for the klast past two years.I went to see a doctor about them and could not get any resolution.I have also had panic attacks that started about 2years agao…I had been taking Nexium for approx.4-5 yrs.I a have also take the other medication that they give you for Gast.Refux Disease…when I first tried to come off I was experiencing migranes…my wrist is swollen and no one knows why?
Brenda
I have taken prolosec for eight yrs and then had the surgery to fix the gerd. But I have degenerative disc disease and my back also fractured just from bending over. With all my back and neck problems i can no longer work. I’m only 49 yrs old so now i know the problem from all the pain i’ve been threw.
Dennis
I been on nexium for 8 or more years,tylenol 4s for 5yers,ankes knees hips back,albows,mussels,ligamants extreme pain.i am pissed
rick
I have been taking protonix for 5 years since mgb stomach surgery. Last week I fell b y missing last step on 3 ft ladder backwards on soft grass, and fractured my right wrist in two locations. The next day the proton pump inhibitors are suspect…
Gloria
Wow, just read this article and you guys are scaring the bejeebies out of me. Have been on Nexium for probably 10+ yrs, have now been told my bones are deteriorating and need Boniva. Tried Fosomax, but could not take because of gastro pain which mimicked heart attack. Scared to take Boniva, but now am scared to keep taking Nexium. I think I am going to try holistic medicine.
Lynn
I have been on PRILOCET for several years now and was just put on NEXIUM about 2 months ago. Three years ago, i sneezed and it caused two compressed factures in my mid back. I had to have back surgery, called kyphoplasty, which is where they inject the compressed fractures with a kind of “cement”. Now, 3 years later, i was in excruciating pain in my upper and lower back and after getting x-rays two weeks ago, i found out that i have “SEVEN” compressed fractures and i am facing surgery again in less than 2 weeks. I am very disappointed to say the least. Don’t know whether to contact an attorney or not? This is a very SERIOUS side effect. And i am the one in so much pain and i am the one who will have to endure more surgery, and MEDICARE AND MEDICAID will be the ones who endure paying for this!!! I am mader than a hornet! How about you?????? Let’s get together and have an attorney contact us and see what can be done for compensation. I sure can’t get my spine back to where it was, all i can do now is suffer the chronic pain daily and endure more surgery. It’s just not fair or ethical. There is a place at the bottom of this page to have an attorney review your comments and contact you. There are only two numbers to put in and then just hit “submit”, let’s all do this so others won’t have to endure the constant pain and the permenent deformity that these drugs have caused. I’m mad as HELL and i’m not going to take it anymore! How about you???????
Lynn
I have been on PRILOCET for several years now and was just put on NEXIUM about 2 months ago. Three years ago, i sneezed and fractured two vertabra. I had to have back surgery, called kyphoplasty, which is where they inject the compressed fractures with a kind of “cement”. Now, 3 years later, i was in excruciating pain in my upper and lower back and after getting x-rays two weeks ago, i found out the i have “SEVEN” compressed fractures and i am facing surgery again in less than 2 weeks. I am very disappointed to say the least. Don’t know whether to contact an attorney or not? This is a very SERIOUS side effect. And i am the one in so much pain and i am the one who will have to endure more surgery, and MEDICARE AND MEDICAID
Jean
For several years I was taking Prevacid for GERD and then switched to Nexium about 5+ years ago. I am currently recouperating a fractured tibia in my left ankle and for the past 5 or so years I’v had extreme joint pain in both hands. I just heard on TV that these medications cause brittle bones. Is there any class action suit against the manufacturers?
Mike
I have been dealing with back pain rt leg pain that goes from my hip to my knee been getting worse for about 2years until i can barely walk now.First the doctors thought it was a disc problem tried different fixes nothing helped i said it feels like my leg is slowly deterorating now they say my hip is the problem the socket has holes forming in the bone.I have been taking nexium for 7-8years not knowing until now that its probably been causing my pain everwhere.
mob
I took protonix for 5 years, had to get tmj surgery, fractured about 4 fingers for soft hits. This is ridiculous, I though it was just me, now looks like it was that stupid pill. I’m on Nexium now and don’t feel any better.
sandra
I have been on prevacid close to 10 years, without it I will feel the burning in my throat and the acid backup is terrible! I always had some concerns about being on it for so long of period. what else is left other than suffer,I don’t want to do that!
jeff
‘= have taken Prilosec OTC. Joints and hip and back pain now all of a sudden…is there a class action suit or something that can be done 2 this company for the bilss incured?
Jim
I’ve been on PPI’s for over 10 years. I am 52. I have developed cervial stenosis. I have had lower back surgury. In the last 3 years I have been experiencing debilitating pain in my mid back. I recently had an X-ray on my back and the Doctor said I have a back of a man in his 70’s Today I went to get my Protonix refilled and the Pharmacast told me about the new findings of taking this drug long term.
John
I have been taking Prilosec for 15 plus years, first as a prescription & then OTC once it went in that direction for my acid reflux. I encountered a C-5 fracture, denerative disc disease, and have had severe lower back pain which required back surgery, fusion on my lower 2 disc. I am in constant pain which requires me to take pain meds daily. I have refrained from taking the Prilosec, which results in heart burn, another pain that I now deal with since this new information has arrised. We are now all puppets of the zare drug companies and are all reaping the reprucusions of the lack of responsibility they take. Why did it take over 15 years for the drug companies to realize this threat?
Matt
I have also taken almost all of the listed brands for about 15 years. I started with the perscribed and switched to the OTC brands when I found they were basicly the same as the perscribed and cheeper. Any who, I have never had problems with fractures but I do suffer from major joint and bone pain. With that said, I do take Tums with calciam like they are candy during the time I am out of the OTC type. I am woundering if this is putting me at a lower risk???
dawn
So which is worse…the fractured bones or Barrett’s Esophageal Cancer? My dr. told me I had to take something to avoid that.
Susan
I have taken 2 Prilosec OTC a dau for 3 years to treat GERD and I found out last week that I have a compression fracture in my lower back. My tailbone has also been hurting since January. I haven’t injured myself. I am 3/4″ shorter than I used to be. I am 43 years old! I just heard on tv that Prilosec causes this. Is there a lawsuit against the makers of Prilosec OTC?
Debi
I take Nexium two times daily. In the last 2 years I have had 2 wrist fxs and a fractured vertabre in my back..I had never had a broken bone before then and I am 52 yrs old..Now I am scared to take it and scared not to…
pamela
I have taken these medications for years & have had many fractures & breaks in bones and this is the first I have ever heard that these medications could be responsible for this.This is totally amazing!!!!!
KeIly
I have been taking Prilosec everyday for at least the last 10 years, Everytime I attempted to not take the medicine, I had extreme bouts of nighttime burning choking incidents that brought me to go back on the medicine to stop these nighttime scares and pain. I have always advised my doctors that I take this medicine and they have never given me any advice or concern as for me taking this on a daily basis. The scare of waking up in the middle of the night choking and not being able to catch my breath, along with the extreme burning of the acid in my throat is something I want to avoid.
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