The FDA releases a quarterly newsletter known as the FDA Drug Safety Newsletter. This newsletter gives information about problems with approved drugs. The latest newsletter (Vol. 2, N. 2, 2009) was recently released.
This newsletter provided information about Zoledronic acid, marketed as Reclast and Zometa which are bisphosphonate drugs used to treat osteoporosis. These drugs have been approved for once-yearly intravenous administration infusion for the treatment of osteoporosis in postmenopausal men and women.
This article reported that there have been 24 cases of renal failure associated with the use of Reclast. The median time form the onset of renal failure from the infusion until the event was 11 days. Seven deaths were reported and three patients required dialysis from the drug.
Due to this problem with Reclast, FDA encouraged physicians to avoid the use of Reclast in patients with renal impairment, ensure patients are well hydrated, and report cases of renal problems to the FDA.
I say the FDA should have included one other point; pull the drug from the market. I wrote about the problems with the osteoporotic drugs in Drugs That Don’t Work and Natural Therapies That Do. Why does Reclast cause this problem? All of the bisphosphonate drugs, Reclast included, are toxic substances to the body. They work by poisoning one of the main bone-building cells in the body—the osteoclasts. Furthermore, the half-life of these drugs is much too long. That is why you can give this drug once/year. The body has no way to detoxify from it. Remember, you can’t poison an enzyme for the long term and expect a good result.
I say, eat a better diet, exercise, drink water and take the appropriate supplements you are lacking. That is a much more effective and safer approach for treating osteoporosis.
In my opinion this is a horrible drug and should not be used. Reclast was recommended to my by my Primary Doctor and I was given an infusion on May 29, 2018. I had a horrible reaction including pain to the level that I could barely stand up and had extreme difficulty in walking. I also ran a fever and chills to the point that I soaked all of my bedding several times a night. I also started experiencing hair loss. It also affected my bowel movements and I feel that it affected my kidney function (based upon having had a kidney infection many years ago and the back pain I’ve experienced since…my Doctor, however does not concur). I also lost my taste; so food although I could eat I didn’t want to. I did not vomit, however I had pain in my stomach after eating anything so another reason not to want to eat. My Doctor reported this severe reaction and told me to expect a lot of calls and questions…..to date I have not received a single call. I have spoken to my Pharmacist and she has recommended a natural course of action (unfortunately, it is not covered by my Medicare and I can not afford it). It took me over two months to get back to even close to normal and I still experience the type of pain that Reclast caused, still have headaches with flashing lights and at times the pain in the kidney area as well as the continued hair loss and other extreme pains especially in the knew and thigh area. I would tell everyone to stay away from this horrible drug based upon my severe reaction. Also, it is very frustrating to know that the FDA hasn’t contacted me and obviously doesn’t care. I had started to submit my own forms but didn’t because my Doctor did. Now, I think I should probably submit my own forms just as proof/backup of my horrible reaction. To explain how bad the pain was for almost two months….I was hoping someone would break into my home and shoot me.