The Food and Drug Administration (FDA) is going to be taking another look at Fosamax and other bone building drugs because they could be causing irregular heartbeats in some patients. The FDA safety review of bisphosphonates, a class of drugs often used to increase bone mass in order to treat osteoporosis, was prompted after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.
Bisphosphonates are used to increase bone mass and reduce fracture risk in patients with osteoporosis. They also are also used to slow bone turnover in patients with a disorder called Paget’s disease and to treat bone metastases and lower blood calcium in cancer patients. There are currently 8 bisphosphonates approved for use in the US. They are Fosamax, Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.
Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.
A second study published in the same issue of the New England Journal of Medicine cast doubt on another bisphosphonate, Reclast. In a study of 7,736 postmenopausal women with bone-thinning osteoporosis, the risk of a serious case of irregular heart rhythm was more than double that in the other patients.
In announcing the bisphosphonate safety review, the FDA said that it was “unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.” The agency will be seeking additional data on the possible atrial fibrillation risks associated with these drugs, and it expects the safety review of bisphosphonates to take about 12 months.
This is not the first time that the safety of Fosamax has been questioned. The drug has been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.
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March 9th, 2009 at 2:14 pm
I had the iv Reclast and had a horrible reaction to it . I had the flu like symptoms first and after three days of not being able to walk well falling etc. I was paralized from the waist down for three days. I still have major pain in my groin and thumbs from the drug. It has limited my life a lot and forced me to give up doing art shows etc. Is there any help for this or law suits. Thank you. Sarah Hood
October 21st, 2009 at 7:39 am
After a year and a half, I am still unable to have my life back. About two months after having the Reclast injection, I suffered excruciating pain and difficulty in walking. This went on for 7 months and while my pain is not excruciating, it still prevents me from doing anything other than some laundry and cooking. I cannot sleep at night in a regular bed because laying down causes my joints to hurt so bad someone has to help me out of bed.
I would like to know if this drug even helped women.
November 15th, 2009 at 3:35 pm
Thanks to the above problems I am cancelling my scheduled first Reclast Monday morning.
November 15th, 2009 at 8:18 pm
I had the reclast infusion in Aug. of this year. I had a very bad reaction from it and I am still in a lot of pain. I have hearing loss in my left ear and very loud noise in the same ear. It is so depressing to me. Has anyone had these symptoms from this infusion? My life has not been the same since this infusion. Instead of my osteoporosis getting better, I feel that it has gotten worse! Please go to INSPIRE.COM AND READ MY STORY!!!
I wish someone understood what I went through and what I’m still going through.
THANKS FOR LISTENING!!!
December 3rd, 2009 at 9:28 pm
I had my first ReClast in 2008. I was in bed for a week, unable to move and constantly throwing up. This September I had my second ReClast treatment. Now I am having all kinds of health issues. I have difficulty breathing. I have been to a pulmanary specialist and do not have any lung problems. I have excrutiating cramps in my arches of my feet at night and also numbness and tingling in my hands and arms. My vision is getting worse and I am now loosing my balance. My joints and bones hurt all the time. I have since quit working due to the pain. Has anyone else had similar symptoms. As of now, I will not continue with ReClast next year.
January 6th, 2010 at 6:36 am
I had an infusion of Reclast on November 7, 2009, and have been very ill since then. Irregular heart rhythm,continuing urinary tract infection, headaches, dizziness, nausea,joint pain, all of which have caused me to miss work. Will Merck be sued for what it’s done to me and many others? I am 67 years old.
January 12th, 2010 at 8:37 am
I had the Reclast on November 19,2009 and I have also been ill ever since. I ended up in the hospital on the 20th with high fever, headache joint pain , chest pain. I have not been well since and wished I never got this IV. I have missed so much work that I’m getting ready to get fired. Plus my joints pain and headaches are getting worst and now I can add depression on with it. Does anyone have a clue how to fix this? Merck poisoned me.
January 14th, 2010 at 5:44 pm
I had infusion of Reclast in August of 2008. I had terrible body aches within hours and then about 2 months later I developed a hearing loss and ringing in my left ear. Then around the first part of 2009 I developed what sounded like quick loud noises in the left ear usually after being in a quiet atmosphere or trying to go to sleep which was very unnerving. I to this day still suffer from these ear noises and muffled hearing in the left ear and MRI’s and all other tests have shown nothing physically wrong. Anyone else have these same symptoms????
January 14th, 2010 at 10:36 pm
I had my first and only reclast infusion in aug. 2008. I am only 45 but due to medication I developed weak bones and was told that i needed this. within hours of the infusion i had severe muscle and body aches and fatigue which lasted a day or two but still have off and on aches and fatigue to this day and my stamina is not what it used to be. The worst effect was the ringing in my left ear that came on a few months after the infusion. If you’ve ever heard what a locust sounds like in the high pitch frequency sound they have, that’s what it sounds like. i then in the first part of 2009 began having clusters of quick loud sounds in that ear whenever i was trying to relax and go to sleep or after being in a quiet room for awhile. these sounds last only a second or so but literaly make my whole body flinch from being startled by them. sounds similar to water being dropped in a hot fryer. i have had mri’s, blood tests, etc. and nothing has shown up but what I do know is my life has changed drastically since taking this infusion. Has anyone out there had such ear problems and is this related in any way to the jaw muscles or is this some inner ear problem caused by the reclast.
January 29th, 2010 at 6:10 pm
I have a hard time hearing for the past month, in my left year and ringing in my year, everything i hear sounds muffled. I have purchased many products for my ear. The ENT doctor said i was fine, just lossing my hearing. I hear fine but its all muffled. I hate to be around alot of people because i cant unedertand them to much noice. Also I have flu like sytems.