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Prilosec, Nexium Bone Fracture Risks May Be Dose Specific: FDA

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According to an update provide by federal drug regulators this week, the risk of bone fractures from Nexium, Prilosec, Prevacid and other heartburn drugs only applies to prescription strength versions of these drugs, as patients at the highest risk for fractures received high-doses or used the medications for more than a year.

The FDA issued an update to an earlier drug safety communication yesterday, indicating that it has determined that use of high doses of a class of drugs known as proton pump inhibitors (PPIs) for more than a year can increase the risk of osteoporosis and fractures of the hip, wrist and spine.

The agency’s findings mean that a warning added last year to prescription-strength PPIs will not be needed for the over-the-counter (OTC) versions of the drugs.

The OTC versions of the drugs are at much lower doses than the prescription strength versions. They also are only intended for 14-day treatments up to three times per year. FDA officials said they are aware that some consumers may take the OTC heartburn drugs for longer periods of time than recommended and said healthcare professionals should be aware of the fracture risk if making such a recommendation to their patients.

The FDA first announced in May 2010 that warnings would be provided about the risk of bone fracture side effects from the heartburn drugs, but warnings were only indicated for prescription strength versions. Drugs affected by the labeling changes included prescription strength Nexium, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo.

The warnings came after FDA drug safety reviewers looked at a number of epidemiological studies into PPI bone fracture risks.

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.

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12 comments

  1. jeff Reply

    do to a fall in 2001 i had to be put on pain and norflex which caused stomach problems.the dr. put me on nexium for two yearsin which time i started having bone pain in my back and hips. After going to several doctors none of them could find anything wrong with me until i saw a dr. who did a bone dinsity test and found out that i had osteoporosis that i was a -3.7 had several fractures in my spine.After more test i was told that i had hypogonadism.this was 6 years ago and i’m still a -3.7and can’t work because of all the medication i’m on .I also have 3 bad disk in my lower back that are bad but can’t have surgery because of the osteoporosis.i was on these PPI for almost 5 years .i will be 47 this summer this is no way to live my life and for my wife and kids to have to see me in so much pain.

  2. Karen Reply

    I took Nexium for years due to reflux, I fell and broke my leg…I wonder if taking the Nexium for so long played a part in that? I finally quit taking it after I found out that I was SEVERLY B12 deficient, because I went undiagnosed for so long, I now have permanent nerve damage in my feet and have agonizing pain everytime I walk………

  3. Pam Reply

    I took Nexium for about 7 years. I am now 52 years old and have been diagnosed with osteoporosis which is pretty severe for my age. My T-zone number from this year’s bone density test was -3.1. The year before it was -2.7. Severe osteoporosis has a T-zone score of -4.0 which I am not far away from. I have a T-zone score of a much older person. I asked my doctor if it would have been caused by the Nexium that I had taken for so many years and then I saw a commercial on tv about a month ago with the warning that it may cause osteoporosisif taken for more than 1 year. I have since stopped taking it.

  4. Robin Reply

    I have errosive esphaglaitis and was taking Nexium twice a day for about 9 months when I fell and broke my foot and severly sprained my ankle. The bone in my foot would not heal and I had to to have a screw palced in my foot. I am still dealing with ankle pain 9 months later. Not only that but my erosive esphagalitis has gotten worse. I have also got hip and back pain since taken Nexium. Is any of this related to the fact of the amount of Nexium I have been taking. I am now on Prevacid and Zantac.

  5. SANDRA Reply

    MYMOM WAS PRESCRIBED NEXIUM BY HER DOCTOR FOR HEART BURN AND SHE HAS BE COMPLAINING ABOUT HER LEGS ACHE AND ALSO SHE HAS BEEN VERY OFF BALANCE SHE ALREADY UP IN AGE SO I THINK THAT IT REALLY HAS EFFECT HER.

  6. Ruth Reply

    When I voiced my concern to my doctor he just said, \”Do you want the reflux or weak bones?\” I am weaning myself off Nexium and watching my diet even more closely!

  7. Patti Reply

    My husband and I have been on Nexium for several years now and have degenerative arthritis, which has been getting worse. My legs have just started hurting so bad I feel like I’m going crazy. The doctor wants to starts giving me shots every 6 months of Prolia for this disease.

  8. Sue Reply

    I took Nexium for approximately four years and quit taking it because I was tired of arguing with my insurance provider. I am now scheduled for back surgery. The procedure is 8 to 10 hours long and my spine in being fused. The neurosurgeon has told me that the bones in my hips are very weak and I am in continuous pain in the lower back, hips and legs.

  9. William Reply

    I went to the Doctors office yesterday, on May 27, 2011. I found out about the nexium scare about a month ago. My brother and sister in law
    told me about the nexium scare I take nexium two times a day for 2 year.
    Well I requested the doctor to put me on another medication. And the man told me that all PPI were the same. He also told me that it was just old women in thier 70ths getting osteoporsis, who fell and broken thier hips The man LIED through his teeth.

  10. Neal Reply

    I see all the lawsuits that seem to get the people restitution for bad drugs, I have used prilosec from 2001 till they discovered the bone fracture problems, but the dozens of attorneys I have contacted will not even consider the case. I am now 100% disable, in constant pain, and all hopes for a comfortable retirement has been ripped from my life, the doctors tell me there is little they can do to fix the problem and I now am trying to learn how to live on the street because no one can or will help me with this problem.
    Frankly I think the attorneys who say they help people with bad drug problems, don’t exist and the so called restitution’s they get are nothing more than delightful fiction.
    DO NOT BELIEVE ANYTHING YOU READ ABOUT THE SO CALLED ATTORNEYS THAT ARE WILLING TO HELP, ALL THEY WANT IS THOUSANDS OF DOLLARS AND WILL NOT GET YOU A RED CENT IN RETURN!

  11. Frank Reply

    William, he DID lie to you. I have been on Nexium for over 10 years and at the age of 52 I now have osteoporosis. I am looking for Canadains to join in a class action law suit against Astrazezeca. They had a very good drug in Prilosec but changed one compound and made Nexium which is 4 times stronger….4 times less acid in your body and 4 times less acid to break down foods that would normaly be absorbed into your body. Calcium that wouls be absorbed into your bones now can’t and they knew about this problem. People must do something.

  12. Tina Reply

    I have been on acid reducers for over 5 years.. they put me on one and then this one and that one.. and still I burn… I have been having gastro issues for years.. they removed the gallbladder and now believe after(4 years) it is either crohns or celiac.. I have suffered and suffered .. Doctors do not care and they only hope to keep us sick and ill.. Remember we are who pays their BILLS.. they know there are risk and they never tell us… I am only 33 and I bruise easy and my joints and bones hurt more and more.. after reading this I am not taking anymore meds for heart burn.. This is scary..They had me on prevacid 4 times in a year.. and still they can not tell me what the hell is going on.. Other then my stomach is inflared bleeding red, the villas are all ate up and still they let me suffer and nothing..

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