Fluoride -laced Fosamax and Reclast Linked to Atrial Fibrillation

See other articles throughout this BLOG addressing dangers of the osteoporosis drugs.

See what the Scientific American tells you today about fluoride:
'Second Thoughts about Fluoride,' Reports Scientific American
NEW YORK, Jan. 2 /PRNewswire-USNewswire/ -- "Some recent studies suggest that
over-consumption of fluoride can raise the risks of disorders affecting teeth, bones, the brain and the thyroid gland," reports Scientific American editors (January 2008). "Scientific attitudes toward fluoridation may be starting to shift," writes author Dan Fagin.

"Fluoride, the most consumed drug in the USA, is deliberately added to 2/3 of public water supplies theoretically to reduce tooth decay, but with no scientifically-valid evidence proving safety or effectiveness," says lawyer Paul Beeber, President, New York State Coalition Opposed to Fluoridation.

Fagin, award-wining environmental reporter and Director of New York University's Science, Health and Environmental Reporting Program, writes, "There is no universally accepted optimal level for daily intake of fluoride." Some researchers even wonder whether the 1 mg/L added into drinking water is too much, reports Fagin.

After 3 years of scrutinizing hundreds of studies, a National Research Council (NRC) committee "concluded that fluoride can subtly alter endocrine function, especially in the thyroid -- the gland that produces hormones regulating growth and metabolism," reports Fagin.

Fagin quotes John Doull, professor emeritus of pharmacology and toxicology at the University of Kansas Medical Center, who chaired the NRC committee thusly, "The thyroid changes do worry me."

Fluoride in foods, beverages, medicines and dental products can result in fluoride over-consumption, visible in young children as dental fluorosis -- white spotted, yellow, brown and/or pitted teeth. We can't normally see fluoride's effects to the rest of the body.

Reports Fagin, "a series of epidemiological studies in China have associated high fluoride exposures with lower IQ."

"(E)pidemiological studies and tests on lab animals suggest that high fluoride
exposure increases the risk of bone fracture, especially in vulnerable populations such as the elderly and diabetics," writes Fagin.

Fagin interviewed Steven Levy, director of the Iowa Fluoride Study which tracked about 700 Iowa children for sixteen years. Nine-year-old "Iowa children who lived in communities where the water was fluoridated were 50 percent more likely to have mild fluorosis... than [nine-year-old] children living in nonfluoridated areas of the state," writes Fagin. Levy will study fluoride's effects on their bones.

Over 1200 professionals urge Congress to cease water fluoridation and conduct Congressional hearings because scientific evidence indicates fluoridation is ineffective and has serious health risks. Support them; write your representative here:
salsa.democracyinaction.org/o/2477/t/2782/campaign.jsp?campaign_KEY=21960
Contact
Paul Beeber, Esq.
www.orgsites.com/ny/nyscof
www.FluorideAction.Net
tinyurl.com/6kqtu
516-433-8882
nyscof@aol.com

On October 1, 2007 the FDA announced plans to review the safety of bisphosphonate drugs used to treat osteoporosis in light of two studies published earlier this year in the New England Journal of Medicine.

* Researchers found that the bisphosphonate Reclast™ caused "significant increase in the risk of serious atrial-fibrillation". (Black et al.)

* "Adverse events (defined as events resulting in hospitalization or disability or judged to be life-threatening) were associated with once-yearly infusions of intravenous zoledronic acid (Reclast) for the treatment of osteoporosis in postmenopausal women".

The Reclast study included 7,736 postmenopausal women with osteoporosis. Those treated with Reclast had more than double the risk for developing serious atrial fibrillation.

The second study referred to in the NEJM review is the Fracture Intervention Trial, conducted to evaluate the effects of Fosamax on the risk of fracture. The New England Journal of Medicine notes that data from this study shows that the risk of a serious heart rhythm problem could be 50% greater for those taking Fosamax when compared with those taking a placebo". Heart rhythm problems, or atrial fibrillation, is an abnormal heart rhythm that can increase a person's risk for heart attack and stroke.

Of the 6,459 women who took Fosamax, 47 developed atrial fibrillation; there were 31 reported cases of atrial fibrillation in the group of women that did not take Fosamax. According to the FDA statement, "In both studies, the rates of all atrial fibrillation (serious plus nonserious) were not significantly different between groups treated with bisphosphonate versus placebo".

In its Early Communication of an Ongoing Safety Review, the FDA says that it "is seeking additional data to allow for an in-depth evaluation of the atrial fibrillation issue for the entire class of bisphosphonates. It may take up to 12 months to complete the evaluation at which time FDA will communicate the conclusions and any resulting recommendations to the public".

According to the FDA, there are 7 FDA-approved bisphosphonates currently on the market: alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel W/Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa).

Bisphosphonate use has also been associated with an increased risk for osteonecrosis of the jaw, a condition which can cause tissue destruction.

The FDA says that "Upon initial review, it is 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".

As a precautionary measure, women and men that are using daily, monthly or annual bisphosphonates should talk to their physicians about their individual risk for atrial fibrillation and should be monitored accordingly.

Also, in light of yet another red flag regarding the safety of bisphosphonates, people with or at risk for osteoporosis should practice dietary and lifestyle habits that support bone strength and density.

The Connecticut Center for Health website provides a comprehensive protocol for doing just that. You can find it at: (http://www.connecticutcenterforhealth.com/osteoporosis-treatment.html)

References:

(http://www.fda.gov/Cder/drug/early_comm/bisphosphonates.htm)

Black DM, et al. Effect of once-yearly infusion of Zoledronic Acid 5 mg on spine and hip fracture reduction in postmenopausal women with osteoporosis: the HORIZON pivotal fracture trial. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.

Treatments for Osteoporosis -- Looking beyond the HORIZON Juliet Compston, M.D., F.R.C.P., F.R.C.Path., F.Med.Sci. , NEJM, Volume 356: 1878-1880, May 3, 2007, No 18

Author:Teri Lee Gruss, MS Human Nutrition