x ray of a broken hip with steel pins

We are often asked about long-term side effects of medications people will be taking for a long time. Drugs to treat osteoporosis are usually taken for years, if not decades.

FDA usually does not require long-term tests to determine safety. As a result, there may be significant delays before scientists learn about potentially serious adverse drug reactions.

That appears to be the case with the osteoporosis drugs called bisphosphonates. Some popular brands include Actonel, Boniva, Fosamax, Reclast and Zometa.

Millions of women rely on these medications to keep their bones strong and prevent debilitating fractures. They have been widely advertised on television as a way of maintaining an active lifestyle without worrying about breaking bones.

A new report suggests that these medications are not innocuous. Earlier this year the FDA issued a warning that such medications can sometimes cause severe, even incapacitating, muscle, bone or joint pain.

Such admonitions frequently seem abstract. When you hear a disembodied voice during a TV commercial rattle off a string of side effects, it may be hard to imagine that they might happen to you.

One reader told us about her experience:

“I took two doses of Boniva, a month apart. Following the first dose, I experienced shooting pains in my arms and legs for about six hours, but considered this to be normal after I read the information that came with the prescription.

“Following the second dose, I had severe, flu-like symptoms including fever, unrelenting chills and spasms and intense pains in all of my limbs. I was left with low back pain that made me double up after sitting for short periods of time.

“The experience left me drained and debilitated for nearly a month, and I am just beginning to feel normal again.”

Debilitating pain is not the only possible side effect of these medications that was discovered years after they were approved. Jawbone death (osteonecrosis of the jaw) is a rare but very serious complications associated with bisphosphonate drugs. Oral surgeons worry about tooth extraction for women on these medications.

More recently, researchers have discovered that such osteoporosis drugs may increase the risk of an irregular heart rhythm called atrial fibrillation. Dr. Jennifer Miranda reported to the American College of Chest Physicians (Oct 27, 2008) that serious atrial fibrillation requiring hospitalization was more common in women taking bisphosphonates. This condition can raise the risk of having a stroke, but it is not listed in the official prescribing information for most of these medications.

The FDA began reviewing this issue more than a year ago. A recent update from the agency downplays the danger and concludes, “healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.” The agency does request reports of atrial fibrillation associated with this class of bone drugs be made to MedWatch (www.fda.gov/Safety/MedWatch/default.htm).

Here is one such report we received from a reader:

“I took Fosamax for osteoporosis for over five years and then Boniva for one year. I recently began experiencing shortness of breath when walking or exercising. I could not finish a treadmill stress test because a rapid and irregular heartbeat (atrial fibrillation) was detected.

“My doctor put me through lots of tests and then took me off Boniva. I now take metoprolol and warfarin for the atrial fibrillation. Before all of this, I was an extremely healthy and active 67-year-old woman who walked two miles every day. The atrial fibrillation came on almost overnight.”

These medications offer benefit for those who can tolerate them, but the range of side effects being discovered might make doctors a little more cautious about prescribing them in the future.

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  1. L B

    Have been on Fosamax for several years now.Dr. wants me to sure to take as I am on synthroid. Says that takes the calcium out of bones. About three years ago I told her I thought it made my legs ache she said no. A year or two ago I had such pain in my knees I had her have x-rays done and there was nothing wrong.
    I do have some hip pain which I thought was from falling down stairs 3 or 4 years ago. I have been very worried about taking Fosamax since I used to work as a file clerk in a medical building and over heard a conversation between some drug reps and a doctor or PA. I am really scared now and don’t know what to do.

  2. Johanna J.

    I have just been given a script for Fosamax—actually, the physician took the liberty of calling it into my pharmacy and then telling me. I have just been told that I have ‘significant’ osteoporosis due to years of Prednisone for Polymyositis. Medications that were supposed to HELP me has more than HURT me—darn near killed me.
    Having a significant history of a muscle disease and related upper gastric issues for years, I almost fell over when I was ‘advised’ to take this medication. I’d have figured I’d be the LAST candidate for it.
    My physician really didn’t have any other options once I told her I most likely wouldn’t take it. Am I wrong? Am I being proactive? WHERE and HOW does one find unbiased info on medications being dispensed like candy today? I’ve really been stressing about it and I’ve been angry. I’m beginning to doubt that physicians have my best interest—and I feel this is potentially a dangerous place to be. Is the medication in MY best interest, or a drug company’s?
    Peace All,
    the DragonLady

  3. jrx

    There is so much information on drugs to treat osteoporosis except for reclast. Could I please have more information on this once a year inject-able and all the side-effects that might occur with its use? Since it lasts for a year how can it be discontinued if there are adverse reactions?

  4. evo

    I took Fosamax for years but just quit bc I had jaw pain. Now I want to eat healthy but what is especially good to eat to get good bones?

  5. pmw

    I was prescribed the whole lot osteroporosis drugs over a period of 10 years. I have experienced leg pains and jaw pain. Following a surgery I did not take the current med and my leg pains went away. After that I did not take it again. I later found out I had gluten intolerance which could have been my problem all along.
    After being on a gluten free diet for three years I am pretty much pain free at age 78. I have 6 sisters who have not taken osteoporosis meds and there has not been a broken bone among them. I eat calcium rich foods, take calcium citrate and vitamin D, a multivitamin, and exercise moderately. Feel good.

  6. pat s.

    Several weeks after starting fosamax 5 yrs. ago, I started experiencing severe bone muscle and joint pain. Both my pcp and obg. stated it could not be because of Fosamax so I cont’ taking it. I had numerous test all normal results- no answer for the pain. Pain finally subsided after a yr. I cont’ taking it 4 more yrs.
    I stopped after developing epigastric discomfort and did not restart it. About 2 weeks after stopping fosamax, the same severe bone, muscle, joint pain returned. I have had lots of tests with still no answer for the cause of the pain. Its been almost a yr. since I stopped the drug. Muscle pain is mostly gone but bone pain remains and interferes with sleep.
    My long bones mostly were affected but in beginning even ribs and skull hurt. I have not seen any documentation of pain returning after stopping drug after prolonged use. Has anyone else had same experience? My advice–DON’T take this medication. I am 61 have been in excellent health, have been an avid walker for 25 yrs., some running, my weight is acceptable, I don’t smoke or drink. I take good care of myself, but my DRS. haven’t.

  7. TKH

    My mother has taken Fosamax for many years and just recently has had a major problem that her MD’s have decided is related to Fosamax. She had some dental work done and now has Osteonecrosis of the jaw. She has been in severe pain since around Thanksgiving and has been hospitalized 3 times for pain management and hydration. All the articles that I read and send her don’t really give a good treatment option.
    Most say to treat with antibiotics, antiseptic mouth rinses, possibly hyperbaric oxygen, possibly pull a mucosal flap over the exposed bone, and (some say do and some say don’t) debride the bone. The last is controversial. Many state that if you debride the bone you will just end up with new dead bone. If anyone has treated or been successfully treated for this condition, I would like to know what route they took. Thanks.

  8. b.m.l

    Took actenol, just two pills, had a serious reaction, hands swelled up and couldn’t move my hands or fingers.this was from taking 1 pill one week and 2nd week one more pill and then the problems happened. stopped taking them right away, it took over 2 months for the inflammation to be gone. will not take any thing like that again.

  9. Rosemary

    On Actonel for 9 months, and followed all directions. Sudden bleeding from unknown ulcer at Gasto-Esophogeal junction. To ER. 3U blood, platelets, ICU, 5 days in hospital. Endoscopy showed erosion, and bleeding. No previous ulcer hx., or symptoms.

  10. Loufa

    My 66 year old husband was diagnosed with osteoporosis (80% density). All diagnostic tests so far are normal, so now he is being tested for low testosterone. He has Parkinson’s and spinal arthritis, so now I am concerned about whether he should be put on these meds. He suffers severe lower body pain because of his other medical conditions. In addition, he has kidney stones. Any guidance would be appreciated.

  11. jwonder

    A woman who took care of my mother took fosamax and I had noticed she just didn’t have the energy she normally had, and told her I was concerned.
    She is a very active lady who walked every where,exercised daily. She called me from the hospital, being admitted with congestive heart failure.
    She had just had a complete physical prior to starting fosamax with a normal EKG.
    It took her months after stopping the drug, and being under a cardiologists care, to finally start feeling better.
    She was lucky.

  12. ssl

    I took Fosamax for several months and began being wakened every night with hip and leg pain. Fortunately a friend mentioned she, too, had bone pain and her doctor friend who was taking Fosamax also developed bone pain. Then I talked with one of the nurses at my ophtalmologist’s office who had severe back ache while on Fosamax. When I told the fellow who treats my underactive thyroid, he said he’d never heard of any similar problems.
    I told him I stopped the drug and the pain subsided. Clearly he was dubious Foxamax was responsible. How odd that I knew 3 other people reporting problems but at that point the drug was not flagged for more attention. It was good to see the FDA put out the caution earlier this year. Unfortunately, there are probably many times drugs cause problems but patients fail to relate the problem with a medication. Lucky for me someone mentioned bone pain and Fosamax to me – I had not made the association.

  13. Susan

    My mother has had severe abdominal pain since being switched to Boniva infusions (not pills) from Forteo (she had reached the two-year limit on Forteo use). Could this be due to the infusions?

  14. fbl

    The joint and muscle pain and aching bones may be helped with acupuncture. I had a severe reaction to Lisinopril and this treatment has helped.

  15. Odette

    On the 29th of Oct. this year, I had Reclast infused. After a fall in June ..Broken left wrist, broken left knee & shattered Tibia…have OsteoPorsis really bad..
    Had the flu for 4 days after..ached everywhere & many other symptoms..
    I still do not feel well, and still hurt where I always do if stand, sit, stay in same position for long, also SOB is bad as well, I have Heart problems…I don’t think I will do this again in a year…I just have a gut feeling it is NOT good…
    I am 72, I am afraid of many Drugs. Always have problems ..so I steer clear of them..
    Thank you for your site. I enjoy reading it ….

  16. P.W.

    Re “How safe are osteo drugs?” (N&O, Nov. 16): Your on-line editorial was more informative than the abbreviated version that appeared in the newspaper, but I still have questions I hope you can address: Do debilitating side effects such as incapacitating muscle, bone or joint pain show up early if they are going to occur at all? Are debilitating side effects more likely to occur with the once-a-month pills, rather than the once-a-week pills? My mother (age 83) had her first bone density test this year, was diagnosed with osteopenia, and was prescribed a once-a-week drug for osteoporosis.
    She took the pills for a few months, but because the cost was burdensome, she then accepted a free sample of a once-a-month formulation offered by the pharmacist. Nearly immediately she experienced severe muscle, bone and joint pain in her legs and hips, most painful and crippling upon arising in the morning. Her condition would improve gradually over the day. It has been 2 months since she took the once-a-month pill, and her symptoms are milder but persist. She is otherwise healthy and active (daily tai chi, climbs stairs to her apartment, gardens). I am 61 and was diagnosed with osteoporosis 3 or 4 years ago.
    I began taking weekly Actonel and now weekly Fosamax, as well as 1300 mg calcium citrate with vitamin D daily. I have experienced no apparent adverse effects, and within 1 year showed improved bone density in lower spine and hip. My mother, of course, will not take these drugs again, and is outraged that pharmaceutical companies would even market drugs that have such possible adverse effects in a small but significant portion of the population. She does not know when she will be free of crippling pain and stiffness in her legs and hips. Should I be concerned about similar side-effects occurring even though I haven’t experienced any yet?

  17. Sue K

    I took Fosamax for over four years. During this time, I experienced achy joints and muscle pain, but didn’t know the discomfort might have been attributable to Fosamax. I also experienced an irregular heart beat, which has continued. I will refuse to take it again.

  18. d

    In 1995, I took Fosamax for five months. My bowels became almost impacted and I had severe, severe constipation — stool was like clay. I also developed esophagitis and severe heartburn. I took the drug according to directions.
    I stopped it and never took it again. I didn’t feel very good when I took it. I’m glad I had enough common sense to stop it. I would never take these drugs again.

  19. JF

    Please tell me which drugs have come on the market with only a few weeks or months testing for safety. This is a bold claim that you should follow up with facts. Otherwise you will lose credibility with other health professionals.

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