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FDA Alert for Users of Osteoporosis Drugs Fosomax, Actonel and Boniva
June 19, 2009 | 17 Comments
Posted by: k daniel
In the last few weeks several studies have appeared alerting women to the severe side effects of biphosphonate drugs like Fosomax, Actonel, Boniva, commonly prescribed to prevent osteoporosis, and to treat osteopenia. One study concluded that women using Fosomax are almost twice as likely to develop irregular heartbeat, or atrial fibrillation. Another team found an increased incidence of a jaw tissue infection, and in a large seven year study, Canadian researchers found that this class of drugs nearly triples the risk of developing bone necrosis, that can result in “incapacitating pain.” A fairly strongly worded FDA alert **suggests that use of bisphosphonates can lead to “the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain” and that health professionals should consider temporary or permanent discontinuation of the drug.
* The FDA warning specifies these bisphosphonates, marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa, in their warning.
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To listen to an NPR special, The Biography of a Osteoporosis: How a Bone Disease Grew to Fit a Prescription, click here.
For the latest research on calcium, dairy products and building bone health through balancing acid and alkaline foods in your diet, click here.
To find out about the medical uses of yoga to prevent and reverse osteoporosis, or to participate in a Columbia University study, click here.
To read about the importance of Vitamin D in women’s health at midlife, and in bone health, click here.
For the newest findings on ‘brittle bones’ and the increased risk of femur fractures from use of biphosphonate drugs in some women, click here.
For a discussion on bone health, the possible causes of bone loss, and what you can do about it, read Christine Northrup, M.D. on Osteoporosis.
To learn more about the health claims and hidden risks of biphosphonates, sign up for our free special report, The Selling of Osteoporosis. We’ll also update you about our upcoming Women Doing It For Ourselves – Build Bone Health for Lifelong Vitality program with Integrated Health specialist and nutrition educator Dr. Judith Valentine, Ph.D.
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Hi, I want to comment on the above article. ‘Actonel’ was prescribed by my internist. I took it for a couple of months, and developed severe stomach pain. I went to see a different internist. When I told him of my symptoms, the first thing he asked: ‘What medications are you taking’? I told him “Actonel”. He told me to stop taking it. This has been over 2 years, and I am still suffering from digestive problems…PLUS, I developed a ‘ridge’ of extra bone in my chest!
I try to cure my health problems with herbs and a good diet, but, I’m aware that at 85, my body is deteriorating despite.
Athena
I was prescribed Actonel in May 2007. Within 30 days I had excruciating ankle pain and within 60 days I had ankle, foot and hand pain. I could not zip my pants, or open a jar. I also have muscle pain in my lower extremites. My doctor said it had nothing to do with Actonel, that it was plantar fascitis. Also in my hands?? I am a RN and now – two years later, still have the pain. I am relieved to see the FDA alert substantiating my symptoms and am even more convinced it is the Actonel that caused them. Biphosphonates have a 10 year half life. So, I am hoping it will resolve within time. All lab is negative.
Hi Michele -
Unfortunately your experience and your doctor’s response is not that uncommon. Many physicians are unaware that these drugs can cause the bone and muscle pain that you experienced. This side effect is much rarer than the GI disturbances that many women experience, however it can be quite debilitating when it happens. As a nurse I am sure you are aware that once a drug is approved for use it is very difficult to assess the incidence of side effects that were not overtly demonstrated during the clinical trials as there are no good systematic methods for reporting them so we remain in the dark as to how many women actually may be at risk for this particular side effect. Conversations like this are so important. If we can successfully get more and more women to report these side effects we will begin to get a much better picture of the actual percentage of women who are at risk and a clearer picture will emerge of the benefit/risk ratio. Thanks for sharing your story. Jennifer
I am an eighty year old male. I have a significant history of cardiovascular disease.
I have had seven heart bypasses and have had my aortic valve replaced with a bovine valve. The last was in 2002. I am now retired. I have a lot of back pain. MRI shows I have two or three herniated discs in my lower back. I also have peripheral vascular claudication in my legs. From the calf just below my knees there is no evidence of a pulse. However, there is a pulse in my feet in the area of the Achilles heel. I have difficulty walking any just short distances due to both the lower back pain and the pain in my legs. I cannot stand for more than a just several seconds; have to sit down. I am also a diabetic which I know can interfere with other problems not necessarily associated with diabetes. My GP sent me to an edrochronologist (sp) a month or so ago as my calcium level reached (11), one point higher than the max prefereed level of 10 (ten). Took Dexo exam and extensive urinalysis. I was told both tests were OK. Over a month has passed since the results of the report were passed along to me. Out of the blue the office of the Endrinol. called me to come in for an apptmt. I asked “why” because the reports were favorable. I declined as I felt the clock had run whereby calling for a Medicare visit was due. Told my GP. He thought I should make the apptm to see what the Endocrin Dr had to say. I found out in the meantime while making the apptmt that INDEED the clock had run and it was therefore time to see me again. I visited with the Endocrin at noon today. She said that my bones were weak and were susceptible to break bones if I fell. I have had a couple nasty falls over the past five years but broke no bones. Endocr Dr said I should be taking either Fosomax, Boniva or Atenenol – she said Fosomax is now in generic form. That is after I told her I didn’t want to take more pills. I assume she was considering the cost of the drug. Cost wasn’t my problem. It was because I already take so many pills (about 11 or 12 each day plus Vitamins C D & E and over the counter pain medications) that I was getting sick of taking so many pills. I guess my question is should I start taking Fosomax or any of the other medications for osteoparosis?
Dear Mr. Henderson,
You’re facing some tough choices. I’m sure you appreciate that we can’t really advise you one way or another. What we attempt is to give you the most accurate information about drugs, particularly if we feel the information that people have access to isn’t accurately portrayed. We hope that, armed with the facts, you can have an honest and open conversation with your health care providers and arrive jointly at the best plan of action for you. We wish you the very best. Jennifer
I have been experiencing multiple dental problems and am convinced this is due in part to
my use of fosomax over a period of more than 5
years, I am losing 3 teeth in little over a
6 month period.
I have been on Fosomax for two and a half years. All of a sudden I am having dental problems. I am 69 years old and have excellent teeth (only two cavities) all my life. I have taken good care of my teeth with regular cleanings and exams. It is very strange that now I have dental problems. Do you think fosomax is the culprit? Have you had similar complaints?
Hi Rosie,
Betty (above) has also just today commented about her recent dental problems. Lawsuits against Merck do include death of jaw bone (jaw necrosis) resulting from biophosphonate use, with painful consequences requiring surgery. Teeth are nourished and embedded in the jaw. Not very helpful towards solving it after the fact, I’m afraid. Kathleen
Hi,
I took one pill of Actonel in April,2009 and developed severe atrial fibrillation as well as flu like symtoms. Then I changed to Boniva. After 7 months I developed SEVERE bone pain in my back and hips and also pain in my heel.My teeth became sensitive and my jaw ached.I developed heartburn. My hemoglobin went from 14 to 10 and my platelet count dropped from 225,000 to 150,000.I stopped taking Boniva and after almost 3 months I am almost back to normal except for the heel pain. I feel as if this medicine was a poison in my body.I want to find natural remedies for my slight osteopenia of my hip bones. I take 1500mg. of calcium and 2000 units of Vitamin D on the advice of my doctor but I do not want to take any bisphosphonate drug again.
I took Actonel and Boniva each for a few months and developed the same bone pain symptoms that I have read here. This is such a terrible experience for many people and I feel that these drugs should be pulled off the market before people are ruined permanently.Is there anything that we can do to convince the FDA?
Susan,
In my opinion, a very major weakness of our FDA and drug surveillance system is the lack of a mandatory reporting mechanism for drug side effects by physicians and other health care practitioners. In most cases reporting of suspected drug side effects that patients experience is entirely voluntary. The good news is that anyone can report a side effect and everyone should do this. The bad news is that very few people know that this is available to them and many. many side effects go unreported. I urge you-if you haven’t already- to download our free report on “The Selling of Osteoporosis”. You will find information about how to officially report the side effects you are experiencing.
The only way our collective voice can be heard is with enough hard data that can’t be ignored.
I took boniva for two months I started having pain in my knees and hands dental problems and abscessed teeth. thanks for the post this helped me a lot.
Hi Sassy,
You are welcome! Thanks for sharing your story, it’s sure to help others.
After having issues with Boniva…my doctor suggested that I have Reclast once a year.
A day or two after the Reclast infusion I developed flu-like symptoms and an extremely rapid heartbeat. Following that I also began to have heartburn….which I hadn’t ever experienced before.
I continue to have the fibrillations almost every night….as well as esophageal issues when I first eat something.
I have been checked out by the doctor…and she has me treating the symptoms…but, was not concerned.
After reading about this study, I am realizing more and more that these symptoms are the result of the Reclast.
Now I am wondering what to do in a year when it is time for the Reclast again?
I have high end osteopenia…just a fraction away from osteoporosis and take 1200 mg. of calcium with vitamin D daily.
Hello LG,
Thank you for sharing your experience. Reclast as you may know is a bisphosphonate- the same class of drugs as Actonel, Boniva and Fosamax and therefore would be expected to have similar side effects.
If you are concerned about continuing to take Reclast it is important to become informed about the different options available to maintain your bone strength and flexibility. When we are diagnosed with osteopenia or osteoporosis the one thing we cannot do is put our head in the sand and hope it will go away.
You mentioned you were taking calcium and Vitamin D- both are important but only part of the necessary nutrients you need for strong bone health. If you want to choose a non-drug approach you need to make sure you are eating a diet right for you, exercise regularly, and take a few supplements and then monitor how you are doing. It takes commitment and not nearly as easy as swallowing a pill but the rewards are much greater.
If medication feels like it is the best choice for you there are other types of drugs that are being used for osteoporosis- you need to have a discussion with your physician about what might be the best option for you.
Good Luck
Jennifer
I took FOSOMAX 70 mg PLUS D for seven years then I am taking Alendronate Soduim 70 mg (generic for FOSOMAX) for six months with Caltrate calcium with Vitamin D two a day. I do not have any problem with the product.
Erna
Erna, this is good news – and you might still want to be vigilant. This report came out today, saying that doctors are recommending against taking any of the biphosphonate drugs for more than five years. The FDA required Merck to post the additional side effect in its insert: that taking these drugs has been found to break the femur, or thigh bone, of some women, even with minimal impact. http://abcnews.go.com/WN/WorldNews/osteoporosis-drugs-fosamax-increase-risk-broken-bones-women/story?id=10044066&page=3 Best wishes, Kath
I started on Fosamex & then was switched to alendronate which I have been on for years. I have not seen this drug listed along with the other drugs. Is alendronate also causing problems? I have been having pain in my hips since I have been taking the medication.
Hello Diane
Alendronate is the generic form of Fosamax. It is the same drug but less expensive than the brand name.
I took Actenol (that is one pill a week) for 9 weeks. I stopped taking it when I experienced pain in my neck & down my back. Also, my tongue felt swollen. I stopped taking the drug and felt that this drug would go the same way HRT went. The side effects outweigh the benefits.
It does feel like an echo doesn’t it? Women listening to our own bodies is our best guide. Disease happens when we stop listening and get out of balance by giving our power away. Good for you. k