Health Highlights: Dec. 3, 2010
Obesity Pill Fails to Meet All FDA Criteria FDA Warning Letter Sent to Maker of Tooth Straightening System Campaign Seeks to Reduce Patient Radiation Exposure Child Nutrition Bill Approved by Congress
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.
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.
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.
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.