Prilosec, Nexium, Other PPIs Can Cause Low Magnesium Levels: FDA

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By: Staff Writers | Published: March 3rd, 2011

Prescription strength Prilosec, Nexium and similar stomach acid reducing drugs, known as proton pump inhibitors (PPIs), will have to carry new label warnings alerting consumers to a risk of low magnesium levels, federal drug regulators announced Wednesday. 

In a Drug Safety Communication, the FDA says that it has determined that long-term use of proton pump inhibitors (PPIs), like Nexium and Prilosec, may cause low serum magnesium levels; a condition known as hypomagnesemia.

The FDA will require new label warnings for all prescription-strength PPIs, including Nexium, Prilosec, Zegerid, Prevacid, Protonix, Vimovo and Aciphex.

Over-the-counter versions of the drugs are not affected by the warning because they are marketed at low doses and only intended for 14-day treatments. FDA officials believe there is little risk of hypomagnesemia with OTC PPIs.

Hypomagnesemia can cause serious side effects, including muscle spasms, irregular heartbeats, and convulsions. According to the FDA, the condition cannot be simply treated through the use of magnesium supplements and in most cases the patient had to be taken off PPIs for their magnesium levels to return to normal.

The FDA found more than 50 cases of hypomagnesemia that were likely caused by heartburn drug side effects in medical literature and through adverse events reported to the agency. While in some cases it appeared in adults who had only been taking drugs like Prilosec and Nexium for just three months, in most cases it appeared after about a year of use.

Patients taking PPIs should seek immediate medical attention if they experience abnormal heart rates or rhythms, palpitations, muscle spasms, tremors or convulsions. Children may demonstrate signs of hypomagnesemia as fatigue, upset stomach, dizziness or lightheadedness. Patients on Digitek or a diuretic should also inform their doctors when being prescribed a PPI, because these drugs also can cause low magnesium levels.

Healthcare professionals should check the magnesium levels of patients before prescribing a prescription PPI and should periodically check their magnesium levels. They should also educate patients taking PPIs on the signs of hypomagnesemia.

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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There Are 26 Comments So Far • (Add Your Comments)

  1. On the contrary the FDA refuses to report that soy’s contaminates to include; endocrine disruptor, phytic acid, heavy metals, and inhibitor of essential enzymes FDA known to cause a host of severe adverse physiological and irreversible neurological developmental effects are NOT FDA allowed as public information. Why is FDA protecting profits, and not health? For complete information go to http://caretotell.blogspot.com

  2. I’ve been taking Prilosec (a/k/a Omaprazole) for over 25 years with no side effects. My question is, why are these drugs FDA approved and then many years later found to be dangerous to a patient? Another example is Darvon ad Darvocet. These drugs have been FDA approved and used for over 50 years and just recently taken off the market. Herbal supplements which are natural are not approved by the FDA such as dandelion which is beneficial in restoration of the liver; but the FDA has barred health stores from carrying it. You really have to wonder just how serious the FDA is in protecting our health.

  3. I was on Prilosec for 2 months and developed shlozkies ring and vetigo and had problems with my knees which resulted in multiple shot treatments to help it feel better . I underwent many test to find out why I had such bad vertigo I suffered for months with that before they found prilosec caused that. I have had my vision drop off so much that I don’t dive very often and never when the light is fadeing . Is all this from that drug and no one could be able to tell ??I stayed on Prilosec the whole treatment till we found by chance that this caused this !!

  4. I have been taking PPI for over 10 years. From all the information that I have received currently about the possible risk of low magnesium and all the possible side effects that I do have now especially allergies and other muskelar problems. Please help

  5. I’ve been taking Nexium for 3 years and began having severe muscle cramps or spasms at the end of November 2010; it began in my left hip, leg, and lower back. I’ve had severe fatigue and tinnitus over the last several years. I feel hot all the time and am comfortable in only about 68 degrees. The hip cramps became so severe that my sciatic nerve was pinched to the point that I was almost crippled. I had to purchase a walker, cane and a electric scooter. My whole life style changed. None of my doctors had a clue on what was wrong. I had gone to my primary care doctor, a rehab specialist, a Neuro muscular specialist, and two physical therapist. After all their tests, the only recommdation was doing piriformis stretches which helped a little for a short time.

    Unfortunately, in a very short time the cramps in my hip, lower back and calf came back with a vengeance.

    I finally started researching muscle cramps and found low magnesium could be a factor in the cramps as well as fatigue. In addition, I found a web site about the FDA’s (March 2011) findings on Nexium and all PPI’s. They can cause low serum magnesium levels and a warning label should be included on the labels and the same on the information sheets description of side effects.

    In response to this information I started taking Epsom Salt baths (magnesium sulfate) every day, 2 cups in my bath water, soaking for 20 to 30 minutes and taking magnesium supplements. (I researched which was the most absorbable forms and the amount to take.)

    I have improved; however, I am still having moderate hip, low back, calf and muscle cramps, in addition to constant mild sciatic pain, general muscle soreness, stiffness and fatigue. I can’t take too much oral magnesium because it causes diarrhea, and I have to continue to take Nexium because I have a medium size hiatal hernia.

    By taking 40 mg’s of Nexium daily, I’m afraid it is cancelling out the effects of the magnesium supplementation to the point that I’m still deficient and am unable to get my levels back up to a normal level where I am asymptomatic.

    I need help!

  6. I am a 55 year old male who is very physical. I bike 12-24 miles 4-5 times a week. I hike and walk often. Not a smoker and not overweight.
    I have been taking proton pump inhibitors for almost 15 years. I have been on Nexium for at least 6 years. I began experiencing heart palpitations about 6 years ago. I have gone through 2 stress tests and an echocardiogram that revealed no physical or structural problems. I learned about magnesium from this article and began taking quality suppliments. I have not had an arrythmia or palpitation since. Either the magnesium suppliment has fixed this problem or it is a very good placebo. At any rate, I feel good!!

  7. My daughter, age 20 has taken PPI’s for approx. 7 yrs. Hyperplastic stomach polyps were found during a UGI. Changed to RX H2 blocker until 4 mos. ago. Restarted PPI therapy. Two mos. ago began having arm muscle stiffness, limping to just yesterday 5/16/11 difficulty standing, walking. Just learned about the FDA 3/2/11 alert on low Mg. Levels. GI doc. Ordered electrolyte testing. Notified GI doc on choosing to stop PPI med. 10/06 ECG showed tachycardia w/no HX of heart disease. Wrist has made clicking/popping sounds for yrs. Wondering if these have been related to PPI use.

  8. I have been on nexium for 3 years! i have been in and out of the I have been in and out of the hospital! I take nexium for gerd! I am also on a blood thinner now because I had pe (pulmonary embolism) which they can NOT tell me how I got it! I am really disturbed rght now because I am LOST! My lower back always hurt! I have cramps in muy left leg constantly! My !I want answers! I am only 38 years old and livng like I am 98!

  9. Another thing that people may want to consider when taking these drugs is that if they deplete the body of so much calcium within a year so that you are at risk for bone fracture, does that not mean that there is no calcium in your body? Calcium is known to aid in preventing colon cancer and is necessary for proper cell function in cells not becoming cancerous. Are we going to be seeing an increase in cancer from PPI use? My husband took them for ten years and now has stage four colon cancer.

  10. I have been taking PPI’s for 30 years or so and have got constant cramps, that go unexplained, pain in my lower back that is now causing me to see a pain specialist for over a year now and Im no better, have aburning in my leg that feels like kiquid fire all up and down my leg, no one seems to be able explain this to me and IV been doctoring with this for as long as Iv been on these PPI’s. But they say I can live without them because of a hyatel hernia, acid reflux, IBS and a burned esphogas.

  11. you aunt heard nothing yet.my sex life went from twice a day to nothing for the last five years.my private area turned purple and my testicles probably glowed in the dark and kept falling in the toilet.my tongue swelled so bad it did not fit in my mouth so i had all my teeth pulled for a little relief.i have been diagnosed with everything but all these idiot doctors always made sure to tell me not to miss my omeprazole.i plan on driving one of their nice cars soon.i take no other drug and can prove everything i say. i have been in the hospital 9 times and always received a prescription for omeprazole whe released.go figure

  12. I have been taking Nexium for 10 years ,and have had low magnesium and Potassium, I never had this before taking Nexium,Neck and Shoulders hurt,they say now it can deplete your magnesium ,Doctors have said they thought I had Liddle`s syndrome ,very rare to have ,Blood tests were inconclusive ,I`ll bet it`s all the NEXIUM side effects,has caused me alot of problems,Plus higher insurance rates!!!!!!

  13. I have been taking prilosic and nexium for over 20 years. About 10 years ago i went to a nurologist to see why i was getting burning, stabbing pain in my left leg, I went through every test possible and the doctor came to the conclusion that i should live with it. The pain was so bad I would scream out in uncontrollable pain. I researched and found a devise that would emit deep heat rays. that did help as long as I never skipped a day. Through research, I found that lower magnesium levels control nerve spasms. I began to take magnesium and the pain subsided. Now, the pain has begun to wake me up at night…the pain has returned. Before reading about the Nexium connection, I stopped taking Nexium. I need to try and restore my magnesium levels and live without the pain. What do I do without the Nexium to control the gerd?

  14. I have been taking prilosec and nexium for 10 or more years and just found out about the effects of taking it i have horrible cramps in my hips and my knees hurt so bad that i cant hardly get out of bed in the mornings has anyone else experienced a burning in there joints of there big toes mine do or nnumbness in like 2 or 3 of your fingertips i just turned 39 years old this is horrible

  15. I was abducted by aliens and they forced me to take Protonix for years which was only about thirty minutes Earth time. There were other abductees that looked like drug reps (beautiful, young blonde women) and think that’s how the aliens got the Protonix samples. Now I have low back pain and cramps, but my GERD is gone.

  16. My advise is: If you can get off the PPI’s DO IT, like yesterday! I took Prilosec for 3 years after a lung biopsy left me with very bad acid reflux. I experienced every bad thing listed here, PLUS an 8mm kidney stone (can be caused by magnesium deficiency) which required surgery to remove. I started taking magnesium supplements, epsom salts baths, probiotics and enzymes. Instead of Prilosec, I used Gaviscon if heartburn was killling me. Eventually I felt better. It took a long time for my muscles and back to stop hurting, though — like a couple of years — but they did. I really thing this stuff can kill you.

  17. Prilosec taken for 17 years , started getting heart palpitations in the night , knee pain , and soft nails , I came off them and all this disappeared, acid reflux worse for at least 2 month , then went a bit better, I would never take this drug again!!

  18. I also have been taking Omaprazole for about 6 years. I’ve had 3 disk in my neck fuzed, and now have several disk and vertabrae damaged throughout my neck, back and lumbar. I have had several injections in my neck and spine to help cope with the pain. I get break-through pain at night so bad that it keeps me awake. I’ll get off the omaprazole for about two days and have to get back on it because of the heartburn and acid is so bad I cant even enjoy a meal without paying the price afterwards.

  19. I have taken Prilosec for about 2 years now and I have many of the syntoms that are talked about in this article. I am going to get off it and see how I feel. Thank you tor the info.

  20. I have been taking nexium for 15 years on and off 10 yrs everyday. Had some blood work 2 years ago and potassium was very low 2 different times. Now experiencing extreme hip pain and lower back pain. I am 39 years old. Going to DR’s to find out whats going on.

  21. I had been taking Nexium for about 5 years and I started having massive muscle cramps in my legs especially at night but also during the day. I had every side effect identifed by Nexium. I was told the cramps in my legs was from low magnesium and calcium.
    I stop taking Nexium for about a year and had no GERD Issues and the muscle cramps went away in about 3 months. Unfortunately the GERD Issue is now coming back slowly. I have been told a home remedy of Apple Cider Vinegar can help reduce the effects of GERD. I have been taking it and I have felt it work for a while but the big issue is to try and lay off the top ten foods that cause GERD the most and do not eat three hours before bed and do not lay down after eating for about three hours and keep the head of your bed a couple inches higher. I would love to try any home remedy before having to go back on Nexium but I have read several times where taking the magnesium tablets may not be a good substitute for the loss of magnesium from taking Nexium. If I have to start taking it again I will quit after about a year to give my body a break and recover from the low magnesium and wait to see how long it takes for the symptoms of GERD to come back.

  22. I have been having low potassium and magnesium levels for about 6 months along with severe muscle pain in shoulders and legs. Primary Dr. Sent me to a renal Dr. Regarding my lab levels. Take oral potassium and got that leveled but am taking more than recommended magnesium oxide 1200mg daily and still have low mag. Level. I asked Dr. If the nexium is causing this and he said no. From what I have been reading, he is wrong! Will stop nexium myself and see what happens.

  23. I’ve been taking ppi’s for at least 13 years, I’ve been on nexium for at least 5 years now. When one kind stopped working the doctors would prescribe a different one. I became very sick, have been in and out of the hospital with stroke like symtoms, trouble walking, trouble with my speech, cognitive problems, severe muscle problems, was told I may have parkinsons, I’ve been through hell trying to get a proper diagnosis, I had severe chronic fatigue, IBS, you name it. The last appointment with neurologist told me I needed counseling, I’ve was so bad I could hardly take care of myself, was having spells where I was unresponsive, and my family and I have been so scared. Now I have weened myself of nexium, and some of my symtoms are better, my walking has improved, I’m more myself again, as far as no more spells, but I have bad heartburn, I have to figure out how to fix the heartburn, because I refuse to go back on nexium. I am relieved that its not parkinsons but pissed because I don’t know if I will ever completely recover. Who knows what kind of other bad meds I would have been given, if I would have gone to a shrink, I hate it when doctors don’t know what is wrong with you and tell you it’s all in your head. I think I figured it out its nexium that made me sick.

  24. Please stop taking ppi zantac Prilosec and all the others, the drugs are making you sick, I went through and still is trying to regain my health back, the drugs took me through a anxeity, fatigue , low energy, chest pains, neck pain, headaches, just to name a few, I\’m off those drugs and doing all I can to get back on track , the worst thing about it all is all the test you take at the hospital are neg . they know it is making you sick, but tell you don\’t stop taking your ppi. please get off those med, the withdrawal won\’t last forever.

  25. My husband has been on PPI’s for many years. In April he switched to Nexium. After 3 weeks he became so ill we had to call 911 in the middle of the night. In the ED they found his magnesium level was critically low – .02. After 9 days in the hospital, then 9 more in a rehab hospital he is home and learning to walk again. His doctor in the hospital said she had :”never heard” of PPI’s causing this problem, I insisted he be taken off of Nexium and he started to improve. He now takes Pepcid for GERD and so far it is relieving his symptoms. Nexium made him criticallty ill, everyone PLEASE be careful of these drugs!

  26. In April My husband age 39 went to the doctor for nausea after eating no other health issues. He had a full physical by a internist and all his blood work came back clear. The doctor diagnosed Acid reflux and prescibed Prilosec. All the acid reflux symptoms stopped and he felt good. After some time I started to notice that he wasn\\\\\\\’t acting right he was short with the kids, we were fighting all the time, he complained of anxiety and having too much on his mind, ichiness and rashes, light headed, tingling in his finger tips, lower back pain, fatigue but insomnia at the same time, and finally what made us do some research was severe lack of sexual response and libido. What we found was astounding. He was on this medication for a total of 4 months and after we found the info he scheduled a doctors appointment and stopped the medication.

    The doctor agreed with our thoughts about the what we found and the medication and ordered some blood work to see how bad his levels really were compared to his levels in April. We received a phone call today with a scheduled appointment to go in and talk to the doctor about the results tomorrow. We were told his testerone levels came back very low. It is believed that the medication caused him to not absorb vitamins which has caused the low T. The specific tests they ran were Iron, Vitamin B, Zinc, Testerone, and a complete CBC blood count.

    Since coming off the Prilosec some of the side effrects have cleared up a bit but the doctor now is concerned about getting his testerone and vitamin B level up. To help with his Acid Reflux he started taking a Fiber supplement called Glucomannan about 15min before he eats with 8 ounces of water. This fiber coates the stomach in a gel and he has not had an issue as long as he doesn\\\\\\\’t miss it before meals. We have also changed his diet. I will stress to people that if they do not absolutly need to take this please dont eventually it will do more harm then it might be worth. Had he not been in generally good health and not on any other medication we might never have found out what was causing all of this or even linked it together at all. This medication is marketed as safe and effective which is false and way over prescribed.

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