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FDA Says Bisphosphonates Might Increase Femoral Fracture Risk, Orders Label Change

FDA Says Bisphosphonates Might Increase Femoral Fracture Risk, Orders Label Change

In contrast with earlier reassurance that there was no "clear connection" between use of bisphosphonates and atypical femoral fractures, the FDA now says labeling changes are needed.

Changes to the warnings section of all bisphosphonates given for osteoporosis will highlight the potential risk for subtrochanteric and diaphyseal femoral fractures. In addition, manufacturers will need to include a medication guide for use by patients.

The FDA says that the fractures being reported "may be related to use of bisphosphonates for longer than five years." Consequently, physicians are being asked to reevaluate the need for the drugs if their patients have been using them longer than that.

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What's Happening To Your Health Plan?

Employers already are passing on a bigger share of their health-care costs to employees than they have over the previous decade, according to data from the Kaiser Family Foundation. The Menlo Park, Calif.-based nonprofit found this year that family premiums for firms went up 3% in 2010, but workers' share of those costs rose 14%.

This so-called cost-shifting trend appears to be intensifying. When Zurich Insurance Services Inc., a property and casualty firm in Jacksonville, Fla., conducted its open enrollment last month, it asked employees to pay 10% of their premiums for the first time. The company always has paid 100%, but "we reached the breaking point," says Ryan Schwartz, senior vice president of corporate affairs, citing higher costs generated by the new health-law provisions.

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Weight Loss Medication Pulled from Market

Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

[Posted 10/08/2010]

AUDIENCE: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

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Iphone to Launch on Verizon

http://online.wsj.com/article/SB10001424052748703735804575536191649347572.html?mod=WSJ_hp_mostpop_read

AT&T Inc. is about to lose its lock on the iPhone.

Apple Inc. is making a version of its iPhone that Verizon Wireless will sell early next year, according to people familiar with the matter, ending an exclusive deal with AT&T and sharpening the competition with Google Inc.-based phones.

While Apple is on track to sell 40 million iPhones across the globe this year, the touchscreen handset is facing pressure in the U.S. from phones running Google's Android software, which have been heavily promoted by Verizon Wireless, the biggest U.S. carrier by subscribers.

Apple plans to begin mass producing the new iPhone by the end of the year, and it would be released in the first quarter of 2011, these people said. The phone would resemble the iPhone 4 currently sold by AT&T, but would be based on an alternative wireless technology used by Verizon, these people said.

Data on Clopidogrel and Omeprazole Offer 'Reassurance' on Cardiovascular Risk, Researchers Say

Patients on dual antiplatelet therapy showed no increase in cardiovascular events while receiving omeprazole to lower risks for gastrointestinal bleeding, according to a New England Journal of Medicine study.

In a double-blind trial, 3700 patients were randomized to receive the proton-pump inhibitor (PPI) omeprazole or placebo, while taking both aspirin and clopidogrel. The study had two primary endpoints: gastrointestinal bleeding or pain, and cardiovascular events, such as cardiovascular death, MI, or ischemic stroke. (Cogentus Pharmaceuticals, the manufacturer of the clopidogrel-omeprazole combination pill, designed and sponsored the trial, but the company is now defunct.)

Over the course of a median follow-up of 106 days, gastrointestinal events were significantly less frequent with clopidogrel-omeprazole. Cardiovascular event rates were also less frequent, but not significantly so (4.9% vs. 5.7%).

The authors say the outcome "provides reassurance that there is no clinically significant cardiovascular interaction between PPIs and clopidogrel."

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Compression-Only CPR by Bystanders Raises Rates of Survival

Compression-only CPR by lay rescuers modestly increases survival over conventional resuscitation, a JAMA study finds.

Researchers prospectively studied rates of survival to hospital discharge in some 4400 adult victims of out-of-hospital cardiac arrest not witnessed by emergency medical personnel. All episodes occurred over a 5-year period in Arizona during a public campaign to encourage bystander intervention with compression-only CPR.

Among the principal findings:

• The overall annual rate of bystander CPR increased during the 5-year period, from 28% to 40%.
• Compression-only CPR increased from 20% to 76%.
• Overall survival increased from 4% to 10%; survival was 13% in the compression-only group.
• Good neurological status at discharge, however, did not differ significantly between those getting compression-only versus conventional CPR.

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