FDA Has Questions About Celebrex for Kids
A bid by Pfizer Inc. to expand U.S. approval of its painkiller Celebrex to include treatment of children with juvenile rheumatoid arthritis (JRA) may fall short, suggest U.S. Food and Drug Administration documents released Tuesday.
It's estimated that as many as 60,000 children in the United States have JRA, which causes painful joint swelling and can affect growth and development, the Associated Press reported.
Currently, Celebrex is approved to treat adults with osteoarthritis and rheumatoid arthritis. In its application to expand that approval to include treatment of JRA, Pfizer included a study that concluded that Celebrex (also called celecoxib) works as well as naproxen in treating young JRA patients.
However, the FDA documents released Tuesday note that limitations in the study's design "raise questions about whether it provides adequate evidence of efficacy of celecoxib" in treating JRA, the AP reported.
There are also questions about the cardiovascular risks of long-term use of Celebrex in children. FDA reviewers suggested that more research is needed to answer those concerns.
A panel of FDA independent advisers will review the matter on Wednesday, the AP reported. The FDA usually follows the panel's advice.
World's 1st Partial Face Transplant a Success: Doctors
One year after she received the world's first partial face transplant, Isabelle Dinoire of France is gaining more facial sensitivity and mobility and her medical team has declared the procedure a success, according to a statement Monday by the doctors.
They also issued a new photo that shows Dinoire almost smiling, the Associated Press reported.
Dinoire's face was severely disfigured by her pet dog in May 2005. During the transplant at the hospital in Amiens, she received the lips, nose and chin of a brain-dead woman.
On two occasions, Dinoire's immune system nearly rejected the transplant but she was given immuno-depressants to overcome the threat, said the statement from the medical team.
The doctors said they've "confirmed the anatomical and functional success of this first partial face transplant."
The statement said that Dinoire has weekly medical consultations but otherwise "leads a normal life" and expects to return to work soon, the AP reported.
Small Amounts of Ecstasy Can Affect Brain
Even small amounts of the drug ecstasy can affect the brains of people who've never used the illegal drug, says a study by researchers at the University of Amsterdam in Holland.
The researchers took brain scans and did memory tests on 188 people with no history of ecstasy use and repeated the tests 18 months later. They found evidence of decreased blood flow and memory loss in the 59 people who had used ecstasy (an average of six tablets) during those 18 months, BBC News reported.
"We do not know if these effects are transient or permanent," noted lead researcher Maartje de Win. "Therefore, we cannot conclude that ecstasy, even in small doses, is safe for the brain, and people should be informed of this risk."
The study, presented at the annual meeting of the Radiological Society of North America in Chicago, is the first to look at the effects of low doses of ecstasy in first-time users. Previous research has found that long-term or heavy ecstasy use can harm the brain and cause problems such as decreased memory, depression, anxiety and sleep difficulties, BBC News reported.
AIDS Projected to be 3rd Leading Cause of Death
Within 25 years, AIDS will become one of the top three causes of death worldwide, says a World Health Organization study published Monday.
AIDS currently accounts for about 2.8 million deaths a year and ranks fourth, behind heart disease, stroke and respiratory infections. The new study says that AIDS could kill at least 117 million people from 2006 to 2030, the Associated Press reported.
However, if the rate of new HIV infections can be reduced and access to life-prolonging antiretroviral drugs increased, the number of people who die of AIDS within the next 25 years could be cut to 89 million, the study said.
"What happens in the future very much depends on what the international community does now," said study co-author Dr. Colin Mathers.
The study also estimated that worldwide cancer deaths will increase from 7.1 million in 2002 to 11.5 million in 2030 and the number of cardiovascular-disease deaths will jump from 16.7 million to 23.3 million, the AP reported.
The report appears in the Public Library of Science's Medicine journal.
American Red Cross Fined $5.7 Million by FDA
The American Red Cross has been fined $5.7 million for continuing to violate blood-safety rules and for its failure to comply with a 2003 agreement to correct blood-safety problems, according to a U.S. Food and Drug Administration letter posted Monday on the agency's Web site.
This latest fine is the result of a 2005 FDA inspection of a Red Cross facility in West Henrietta, N.Y., that found 207 deviations from the 2003 agreement. FDA inspectors found problems in a number of areas, including quality assurance, inventory management, donor screening, and blood component manufacturing, the Associated Press reported.
In the letter dated Nov. 21, the Red Cross was given until mid-December to comply with FDA requirements. If the Red Cross fails to meet that deadline, it could be slapped with more penalties.
This latest fine comes on top of nearly $10 million in previous fines for blood-safety violations and for failing to meet the terms of the 2003 agreement meant to settle charges that the Red Cross had committed "persistent and serious violations" of blood-safety rules over 17 years, the AP reported.
Slouching May be Better for Back: Study
Slouching while you're sitting may be better for your back than sitting upright and stiff, says a study conducted at Woodend Hospital in Aberdeen, Scotland.
Researchers used a moveable magnetic resonance imaging (MRI) unit to scan 22 healthy volunteers with no history of back pain or surgery. The participants assumed different sitting positions while being scanned, The Times of London reported.
The results suggest that sitting up straight puts unnecessary strain on the spine and could lead to chronic back pain due to trapped nerves or slipped discs. The researchers concluded that a 135-degree body-thigh sitting position was optimal, as opposed to the 90-degree posture that most people believe is ideal.
"Sitting in a sound anatomical position is essential, since the strain put on the spine and its associated muscles and ligaments over time can lead to pain, deformity and chronic illness," said study lead author Dr. Waseem Amir Bashir.
The study was presented at the annual meeting of the Radiological Society of North America.
One expert said this kind of research is still very theoretical. Dr. Gordon Waddell, an orthopedic surgeon at Glasgow Nuffield Hospital, said it's "human nature" to develop back pain.
"Like a headache or a cold, it seems we all get back pain and most of the evidence suggests that sitting position does not make a difference," he said.