FDA Posts MedWatch Side Effect Alert for Osteoporosis Drugs

Wednesday, February 20, 2008 by: Teri Lee Gruss
Tags: osteoporosis, health news, Natural News

(NewsTarget) The FDA recently issued a statement that bisphosphonate drugs used to treat osteoporosis may cause "severe and sometimes incapacitating bone, joint, and/or muscle pain". The information was posted on the FDA MedWatch website, the agency's online adverse event reporting site, on January 7, 2008.

According to the FDA, symptoms of these adverse side effects can occur within days of taking the drug or arise years after taking bisphosphonates.

The bisphosphonates cited in Medwatch alert include Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid and Zometa.

The FDA alert emphasizes that doctors and patients may not associate severe musculoskeletal pain with bisphosphonates even though this possible adverse side effect is available in prescribing literature.

In 2004 the FDA, aware of the risk for severe musculoskeletal pain in people taking bisphosphonates required manufacturers to update their product labeling and information to include this known serious adverse side effect. It looks like physicians and patients are not connecting the dots in the known association of bisphosphonates to severe musculoskeletal pain.

Unfortunately, a person experiencing bisphosphonate induced severe musculoskeletal pain will likely have to take other medications to alleviate their pain, an increasingly common occurrence: treating adverse side effects with other medications.

Bisphosphonates are also linked to osteonecrosis (destruction of jawbone tissue) and are currently being assessed by the FDA for the potential to cause severe atrial defibrillation. Abdominal pain and esophageal ulcers are other known adverse side effect risks. See NewsTarget article Fosamax and Reclast Linked To Risk For Serious Atrial Fibrillation (http://www.newstarget.com/022420.html) .

According to worstpills.org, the Health Research Group of Public Citizen, published clinical studies have found that while bisphosphonates increase bone density they may not be as effective at reducing incidence of fractures as we have been led to believe.

As we recently learned, Merck and Schering-Plough neglected to submit all of their clinical trial research data for their heavily advertised and prescribed drugs Zetia and Vytorin, specifically data related to adverse side effects and effectiveness of the drug in preventing heart attacks and stroke. See NewsTarget's Mike Adam's article posted January 11, 2008 (http://www.newstarget.com/022485.html) .

According to worstpills.org, Proctor and Gamble, the maker of the bisphosphonate Actonel, engaged in a similar omission of data in a large clinical trial that they sponsored.

The trial included 9,331 elderly women with low bone density. While P&G announced that their bisphosphonate risedronate (Actonel) increased bone mineral density 1% , when they conducted their follow-up phase of the trial, information regarding the outcomes of 3,324 women in the trial (that's slightly over a third of the trial subjects), was not made available. It was omitted from publication and peer review.

As the public learns more about the pharmaceutical industry practice of omitting clinical study data pertaining to serious adverse side effects and lack of effectiveness, both in the FDA approval phase and post market phases of clinical trials, it is obvious that we deserve a better understanding of the adverse effects of bisphosphonates and a much better understanding of their alleged benefits, which of course should be protection from bone fractures.

The FDA MedWatch notice concludes by advising: "Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who are present with these symptoms and consider temporary or permanent discontinuation of the drug".

Sources:

FDA MedWatch (http://www.fda.gov/medwatch/safety/2008/safe...)

Worstpills.org (https://www.worstpills.org/)

Proctor and Gamble sponsored study:
Goodman RL. The effect of risedronate on the risk of hip fracture in elderly women. New Engl J Med May 31, 2001; 344: 1720 – 1721

Bone HG, Hosking D, Devogelaer JP, Tucci JR, Emkey RD, Tonino RP, Rodriguez-Portales JA, Downs RW, Gupta J, Santora AC, Liberman UA. Ten years' experience with alendronate for osteoporosis in postmenopausal women. New England Journal of Medicine Mar 18, 2004; 350: 1189 - 1199.

About the author

Teri Lee Gruss, MS Human Nutrition