Fosamax, Reclast, Other Osteoporosis Drugs to Undergo FDA Safety Review

AddThis Social Bookmark Button

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.

<

You can leave a response, or trackback from your own site.

« OTC Cold Medicines for Infants are Dangerous, Don’t Work Says FDA Study Tobacco Industry Appeal Falls on Deaf Ears at Supreme Court »

10 Responses to “Fosamax, Reclast, Other Osteoporosis Drugs to Undergo FDA Safety Review”

  1. Sarah Hood Says:

    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

  2. Carol Vance Says:

    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.

  3. J.M.Garner Says:

    Thanks to the above problems I am cancelling my scheduled first Reclast Monday morning.

  4. Amelia Parks Says:

    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!!!

  5. Laura Martin Says:

    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.

  6. Olivia Newton Says:

    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.

  7. Debbie Davis Says:

    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.

  8. Ken Herrick Says:

    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????

  9. Ken Herrick Says:

    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.

  10. janny Says:

    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.

Leave a Reply



*
Anti-Spam Image

New Yorks Top Personal Injury Law Firm

New Yorks top personal injury law firm can help you. If you've been injured in a car accident, bus, truck, or train accident, slip and fall, surgical mistake, hospital negligence, work related injury get the help you need!
Injured-In-New-York.com

Merck Vioxx Stock Fraud Attorney

Lost Money on Merck Due to Vioxx? Call 800-LAW-INFO
Vioxx Shareholder Lawsuit

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Toyota Class Action Lawsuit

If you are an owner of a Toyota vehicle that has been named in one of the many recalls issued for unintended acceleration problems CONTACT US TODAY!
www.toyota-class-action-lawsuit.com

Fixodent Lawsuit

Fixodent or Super Poligrip May Cause Nerve Damage. 800-LAW-INFO
Fixodent-Lawsuit.COM

Numbness Arms Legs- Tingling Dentures- Muscle Weakness?

Do you have these symptoms and use denture cream? You may have serious side effects? Get the facts!
denturecream lawyer.com

Denture Cream Neuropathy

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Neuropathy-dental-Cream.COM

Defective Chinese Drywall Misery

It's estimated that more than 500 million pounds of possibly deficient Chinese drywall entered America between 2004 and 2008. An Associated Press statement said that was enough material to build about 100,000 homes. If you or a loved onehas been experiencing problems with corroding metals, foul odors, or sinus and respiratory ailments, your home may have been built with Chinese drywall. Get the facts!
Chinese-Drywall-Answers.com

Chinese Drywall May Cause Severe Health Issues

If your home was built during the housing boom, and you have been experiencing problems with corroding metals, foul odors, or sinus and respiratory ailments, your home may have been built with Chinese drywall. This may be causing severe health issues for you and your family. Get the facts!
chinese-drywall-may-cause-severe-health-issues.com

Chinese Drywall Info

If your home was built during the housing boom, and you have been experiencing problems with corroding metals, foul odors, or sinus and respiratory ailments, your home may have been built with Chinese drywall. Get the facts!
IMPORTANT PUBLIC ANNOUNCEMENT CHINESE DRYWALL LITIGATION UPDATE
7/23/09 Hyatt Regency FL

ChineseDrywall.org

Yaz Side Effects

Yaz birth control pills may cause strokes, heart attacks and/or life-threatening blood clots. Get the facts!
yaz-side-effects-lawyer.com

Yaz Gallbladder Disease Lawsuit

Gallbladder disease is one of the serious side effects associated with Yaz along with blood clots, heart attacks, strokes, and other side effects. Get the facts!
yaz-gallbladder-disease.com

Yasmin Side Effects

Yazmin may cause life-threatening blood clots, heart attacks, and strokes. Get the facts!
yasmin-side-effects-lawyer.com

Drug Injury Search

CHECK RIGHT NOW TO SEE IF THE MEDICATION YOU ARE TAKING IS SAFE!
www.drug-injury-search.com

Zicam Small Loss

Has a Zicam nasal cold remedy robbed you of your sense of smell, and possibly the ability to taste? The FDA has issued a warning for Zicam. Get the facts!
www.zicam-smell-loss-lawyer.com

Yaz Side Effects

Yaz birth control pills may cause strokes, heart attacks and/or life-threatening blood clots. Get the facts!
yaz-side-effects-lawyer.com

Gadolinium MRI Contrast

NSF & NFD From MRI or MRA? Call Our Attorneys Today
www.Gadolinium-mri.com

Injured In Florida?

If you've been injured in a car accident, truck accident, pedestrian knockdown, on the job, or due to malpractice or negligence (slip and fall, dog bite) or any type of personal injury, we can help you,! Contact us today!
www.florida-personal-injury-law-firm.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com

VA Mortgage Refinance

VETERANS! Now is the perfect time to refinance into a lower-cost loan. Get started right now!
www.va-mortgages-refinanced.com