If you missed these news items the first time around, AAOS Now gives you a second chance to review them. Headline News Now, the AAOS thrice-weekly, online update of news
of interest to orthopaedic surgeons, brings you the latest on clinical, socioeconomic, and political issues, as well as important announcements from AAOS.
FDA alert: Bisphosphonates linked to severe musculoskeletal pain
The U.S. Food and Drug Administration (FDA) has issued a MedWatch safety alert regarding the possibility of severe and sometimes incapacitating bone, joint, and/or musculoskeletal pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The FDA recommends that healthcare professionals consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms, and consider temporary or permanent discontinuation of the drug.
AHRQ review takes a hard look at bisphosphonates
A research review conducted by the U.S. Agency for Healthcare Research and Quality (AHRQ) casts some doubt on the efficacy of bisphosphonates in treating osteoporosis compared to some alternatives. The agency examined the effectiveness and risks of six bisphosphonates, as well as estrogen, calcitonin, calcium, vitamin D, testosterone, parathyroid hormone (PTH), and selective estrogen receptor modulator treatments.
It found that among postmenopausal women with osteoporosis, alendronate, etidronate, ibandronate, risedronate, calcitonin, teriparatide (a form of PTH), and raloxifene reduced fracture risk; among men, calcitonin, risedronate, and teriparatide reduced fracture risk. Not enough evidence exists to determine how exercise or taking testosterone compares to medications in preventing osteoporosis-related fractures.
Consumer group claims FDA moving too slowly on tendon injuries
The nonprofit consumer advocacy group Public Citizen filed suit against the FDA on Jan. 3, charging that the agency has ignored calls for stronger warnings about the risks of tendon rupture associated with the fluoroquinolone family of antibiotics. Although the drug labels do list tendon rupture as a possible side effect, the consumer group is seeking an upgrade to a black-box warning—the FDA’s most severe warning. Set in bold type and surrounded by a black box to make it stand out, the black-box warning typically appears at the top of drug labels. Any advertising of products that carry black boxes must also include warning information as part of the advertisement. Public Citizen filed a petition seeking the stronger warning in 2006, citing 262 reports of tendon ruptures between November 1997 and December 2005, along with hundreds of other tendon problems among users of those antibiotics. In filing the suit, Public Citizen claims that FDA is violating its own statutes and putting patients at risk in taking so long to settle the issue.
Review: OA knee treatment guidelines need to be refined
According to a review article published online in the journal Arthritis Research and Therapy, several recent sets of guidelines for the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of knee osteoarthritis (OA) contain differences and lack educational information. The authors used Appraisal of Guidelines Research and Evaluation (AGREE) criteria to examine six sets of guidelines designed to address concerns about cardiovascular risks associated with NSAIDs and published or updated between 2001 and 2006. They found that the guidelines effectively addressed only a few of the AGREE criteria, and that most of the guidelines discuss education and patient activity management interventions only superficially.
Study: Arthroscopy plus exercise is similar to exercise alone for knee pain
A controlled trial involving patients with chronic patellofemoral pain syndrome (PFPS) found that outcomes for patients treated with arthroscopy and a home exercise program were no better than when the home exercise program alone was used. Researchers randomized 56 patients with chronic PFPS into two treatment groups: an arthroscopy group (N = 28) that was treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28) treated only with the 8-week home exercise program. Both groups showed marked improvement during follow-up, yet there was no difference between the groups in mean improvement in Kujala score (group difference 1.1 [95 percent confidence interval; range: 7.4-5.2]) or in any visual analog scale scores. The study was published in the open-access journal BioMed Central (BMC) Medicine.