Here are some of the latest health and medical news
developments, compiled by the editors of HealthDay:
Obesity Pill Fails to Meet All FDA Criteria
The obesity pill Contrave helped patients lose weight in
clinical trials but failed to meet all the criteria set forth by
the U.S. Food and Drug Administration, agency scientists said in a
review posted online Friday.
The four clinical trials conducted by drug maker Orexigen
Therapeutics Inc. found that patients taking Contrave averaged 4.2
percent more weight loss than those taking a placebo. But that fell
short of an FDA guideline of at least a 5 percent difference, the
Associated Press reported.
Side effects such as high blood pressure, dizziness and insomnia
were experienced by patients taking Contrave, which is a
combination of the antidepressant bupropion and the anti-addiction
drug naltrexone.
The FDA review was posted in advance of next Tuesday's meeting
of an outside panel of experts who will discuss Contrave's efficacy
and safety and vote on whether to recommend FDA approval of the
drug, the
AP reported. The FDA typically follows the advice of its
expert panels.
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FDA Warning Letter Sent to Maker of Tooth Straightening
System
A California company that makes the tooth straightening
Invisalign system failed to report information about side effects
experienced by patients, says a warning letter issued by the U.S.
Food and Drug Administration.
Align Technology revealed this week that it received the Nov. 18
warning letter, the
Associated Press reported.
The FDA said there were patient complaints about allergic
reactions, including mouth ulcers and swollen lips, to the
Invisalign trays, but the company failed to comply with federal
rules to report serious side effects associated with medical
devices.
Invisalign says it has replied to the FDA to resolve the issue,
the
AP reported.
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Campaign Seeks to Reduce Patient Radiation Exposure
A nationwide campaign to stop the overuse of radiation during
patient medical exams was launched this week at the Radiological
Society of North America's annual meeting in Chicago.
The Image Wisely campaign includes a pledge to use the lowest
necessary level of radiation during a procedure. So far, nearly 700
health-care providers have signed the pledge, the
Associated Press reported.
High levels of radiation exposure can cause cancer. In recent
decades, increase use of imaging tests, such as CT scans, have
contributed to an increase in the average American's total
radiation exposure.
Experts said the Image Wisely campaign may encourage a closer
look at protocols, increased accreditation of imaging facilities,
and more widely shared standards on appropriate radiation doses,
the
AP reported.
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Child Nutrition Bill Approved by Congress
A child nutrition bill that sets new health standards for school
meals and expands the school lunch program has received final
approval from Congress.
The House of Representatives passed the bill Thursday by a vote
of 264 to 157. The Senate gave unanimous consent to the bill in
August. It will now go to President Barack Obama, who intends to
sign it,
The New York Times reported.
Under the bill, the secretary of agriculture has the power to
set nutrition standards for foods sold in schools during the school
day, including products in vending machines. Schools will be told
to serve more fruits and vegetables, whole grains and low-fat dairy
products.
To cover the cost of more nutritional meals, the bill also
increases federal reimbursement for school lunches beyond
inflation. It also regulates prices for lunches served to children
from families with incomes over 185 percent of the poverty level
(more than $40,793 a year for a family of four) and will provide
automatic qualification for more than 100,000 children on Medicaid
to receive free school meals, the
Times reported.
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