FDA Experts Reject New Diabetes Drug
The new diabetes drug dapaglifozin should not be approved in the United States because it might increase users' risk of breast and bladder cancers, among other safety concerns, a panel of experts advising the U.S. Food and Drug Administration recommended.
The advisory panel voted 9 to 6 on Tuesday against recommending that the FDA approve the drug, which was developed by Bristol-Myers Squibb and AstraZeneca. It's the first among a new class of medications designed to lower blood sugar by having type 2 diabetics excrete excess sugar in urine, The New York Times reported.
The full agency is supposed to make a decision on the drug by Oct. 28, and usually heeds the advice of its expert panels.
Most of the more than 25 million Americans with diabetes have type 2, formerly called adult onset diabetes, the Times reported.
In clinical testing, some 0.4 percent of women who took the drug developed breast cancer, compared with 0.1 percent among participants who didn't take the drug. About 0.3 percent of men who took dapaglifozin developed bladder cancer, compared with 0.05 percent of male participants who didn't take the drug, the newspaper said.
Panel members also evaluated concerns that the drug could cause liver or kidney problems, the Times reported.
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Alzheimer's Blood Test Moving Closer to Reality
A blood test to screen people for brain plaques that are telltale signs of Alzheimer's disease appears closer to reality, the Associated Press reported Wednesday.
Clinical results found an experimental test was successful in detecting the sticky clumps of beta amyloid protein on the brain that indicated the potential onset of Alzheimer's before memory and cognitive problems became apparent, the wire service said.
The test appears to offer a way to screen out people with memory problems who are candidates for more definitive testing, the AP said.
Results on the test, developed by Australia's national science agency CSIRO, were reported at Wednesday's Alzheimer's Association International Conference in Paris.
While brain scans may also reveal the presence of these plaques, the scans "are too expensive and impractical for routine use," the wire service reported.
A clinical study of more than 1,100 people found that the test correctly identified 83 percent of people with high amyloid levels and correctly ruled out 85 percent of people who didn't have this condition.
More than 5.4 million Americans and 35 million globally have Alzheimer's, which has no cure, the AP said.
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12 States Have Obesity Rates of at Least 30%: CDC
A dozen U.S. states now have obesity rates of 30 percent or higher, up from nine states three years ago. No states met the threshold in 2000, the U.S. Centers for Disease Control and Prevention said Tuesday.
Obesity is now a problem in all 50 states, the agency said in a news release. An adult is considered obese if he or she has a body mass index (BMI) of 30 or greater.
No state met the federal Healthy People 2010 goal of a 15 percent obesity rate. In fact, no state had a rate lower than 20 percent, the CDC said.
The agency interviewed by telephone some 400,000 adults nationwide. Regionally, the South had the highest obesity rate at 29.4 percent; the Midwest, 28.7 percent; the Northeast, 24.9 percent and the West 24.1, percent.
Some of the top causes of death are linked to obesity, including heart disease, stroke, type 2 diabetes, and certain cancers, the CDC said.
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Users of Antipsychotic Warned of Possible Drug Interactions
The maker of the popular antipsychotic drug Seroquel will add a warning to its label saying that if it is taken with any of at least 12 other drugs, the interaction could lead to an irregular heartbeat and possible heart attack, The New York Times reported.
A spokeswoman for the U.S. Food and Drug Administration clarified that the label warning to be posted by drug maker AstraZeneca was intended as a precaution for doctors, whom she said could still prescribe Seroquel and one of the other drugs if necessary.
FDA spokeswoman Sandy Walsh told the newspaper that the agency had notice of 17 cases of a certain type of heart arrhythmia among people who took above-recommended amounts of Seroquel and at least one other medication.
The heart rhythm abnormality, called prolongation of the QT interval, is responsible for several thousand deaths in the United States each year, the Times reported.
Drugs that shouldn't be taken in tandem with Seroquel include antiarrhythmic drugs such as quinidine, procainamide, amiodarone and sotalel; antispsychotics such as ziprasidone, chlorpromazine and thioridazine; antibiotics such as gatifloxacin and moxifloxacin; the anti-infective drug pentamidine; and synthetic opioids such as levomethadyl acetate and methadone, the Times reported.
Seroquel's prior labeling had warned of heart arrhythmia risk but hadn't mentioned other drugs that could interact with the antipsychotic, an AstraZeneca spokeswoman said.
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