FDA Must Consider Ban on Antibiotic Use in Livestock: Court
The U.S. Food and Drug Administration must follow through on a 35-year-old proposal that would have banned the use of certain antibiotics in animal feed due to fears about potential harm to human health, a federal district court in Manhattan ruled Thursday.
In 1977, the FDA proposed banning the use of penicillin and two forms of tetracycline due to concerns that overuse of the drugs in livestock led to the development of drug-resistant bacteria that can infect people, the Washington Post reported.
The FDA has never taken action on the proposal and was sued in May 2011 by five environmental, health and consumer advocacy groups. The court ruling forces the FDA to move ahead with proceedings that could lead to the withdrawal of the drugs.
"The scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe," Judge Theodore H. Katz wrote, the Post reported.
The makers of the drugs will be given an opportunity at a hearing to prove that the antibiotics are safe.
"If, at the hearing, the drug sponsors fail to show that the use of the drugs is safe, the [FDA] Commissioner must issue a withdrawal order," Katz wrote.
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FDA Approved Higher Dose of Alzheimer's Drug Despite Warnings:Experts
A higher dosage of the Alzheimer's drug Aricept was approved by the U.S. Food and Drug Administration even though it caused potentially dangerous side effects and worked only slightly better than the existing dosages of the drug, according to an article published Thursday in the British Medical Journal.
The 23-gram version of Aricept was approved by the FDA against the advice of agency reviewers. The approval was granted in July 2010, four months before the 5- and 10-milligram dosages of Aricept lost patent protection, The New York Times reported.
The FDA reviewers noted that a clinical trial involving 1,400 patients showed that the higher dosage failed to meet its goal of improving cognitive and overall functioning in people with moderate to severe Alzheimer's disease.
The trial also showed that the higher dosage caused substantially more nausea and vomiting, which are potentially dangerous side effects for elderly patients with advanced Alzheimer's disease, The Times reported.
The drug was developed by Japanese drug maker Eisai and is co-marketed in the United States with Pfizer.
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Dissolvable Tobacco Products May Have Fewer Health Risks: FDA Panel
While dissolvable tobacco products could pose fewer health risks compared to cigarettes, they could increase the number of tobacco users in the United States, a Food and Drug Administration advisory panel says.
Dissolvable tobacco -- finely milled tobacco pressed into shapes like tablets that slowly dissolve in the mouth -- are one of the cigarette alternatives being considered by tobacco companies for future sales growth, the Associated Press reported.
There is a lack of research on dissolvable tobacco products, which make up a small share of the market, the panel noted.
The findings were posted online Thursday and will be reviewed by the FDA in any future decisions but there's no timeline for the agency to act, the AP reported.
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Army Mental Health Programs Under Review
A system-wide review of U.S. Army mental health facilities is being conducted to determine if psychiatrists overturned soldiers' diagnoses of post-traumatic stress disorder (PTSD) in order to save money.
The review by the Army inspector general comes as the case of a U.S. soldier suspected of killing 16 Afghan civilians has led to renewed focus on war-related mental strain among military personnel, the Associated Press reported.
The service is trying to determine whether changes in PTSD diagnoses were isolated or common practice, Army Secretary John McHugh told Congress on Wednesday.
The forensic psychiatry unit at Madigan Army Medical Center on Joint Base Lewis-McChord is under investigation for reversing PTSD diagnoses in order to avoid the expense of providing care and benefits to soldiers, according to Sen. Patty Murray, D-Wash.
"Not only is it damaging for our soldiers, but it also really furthers the stigma for others that are -- whether they're deciding to seek help or not today," Murray said, the AP reported.
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