Health Highlights: May 20, 2006
Drinks Contain High Levels of Benzene FDA Memo Says Antibiotic Should Carry Stricter Warnings Final Government Approval Given to Barley Health Claim Remicade Approved to Treat Children with Crohn's Disease Surgical Plugs in Ears Stop Severe Dizziness
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Drinks Contain High Levels of Benzene
The U.S. Food and Drug Administration reported Friday it found levels of cancer-causing benzene that exceeded federal standards in five of 100 soft drinks and beverages it tested.
The agency told the Associated Press it has alerted the makers of those drinks, and those companies have reformulated their products or plan to do so. While FDA officials stressed there is no safety concern to the public, one environmental group begged to differ.
The five drinks listed by the government were Safeway Select Diet Orange, Crush Pineapple, AquaCal Strawberry Flavored Water Beverage, Crystal Light Sunrise Classic Orange and Giant Light Cranberry Juice Cocktail. The high levels of benzene were found in specific production lots of the drinks, the FDA said.
Benzene, a chemical linked to leukemia, can form in soft drinks containing vitamin C and either of the two preservatives sodium benzoate and potassium benzoate. Scientists say heat or light exposure can trigger a reaction that forms benzene in the beverages.
Federal rules limit benzene levels in drinking water to 5 parts per billion. The FDA analysis found benzene levels as high as 79 parts per billion in one lot of Safeway Select Diet Orange.
A Safeway Inc. spokeswoman did not immediately return a message left seeking comment, the AP reported.
Dr. Laura Tarantino, director of the FDA's Office of Food Additive Safety, said drinking sodas high in benzene does not pose a health risk.
"This is likely an occasional exposure, it's not a chronic exposure. Obviously, no benzene is something someone wants to have, but the amount of benzene you are getting in a soda is very, very small compared to what you're being exposed to every day from environmental sources," she told the wire service.
But a spokesman for Environmental Working Group, which has accused the FDA of suppressing, information about benzene in soft drinks disagreed.
"FDA's test results confirm that there is a serious problem with benzene in soda and juices," Richard Wiles, senior vice president at Environmental Working Group, told the AP.
FDA Memo Says Antibiotic Should Carry Stricter Warnings
Ketek, an antibiotic that has been linked to reports of liver failure, should have stronger label warnings, an internal memo from the U.S. Food and Drug Administration states, the Associated Press reported Friday.
Sanofi-Aventis, which manufactures the drug, told the wire service Friday it was in talks with FDA officials about those reports.
The FDA has received reports of 12 cases of acute liver failure, including four deaths, in patients treated with Ketek, according to a copy of the memo shown to the AP. Safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic.
When weighed against the number of prescriptions filled for Ketek, the number of reports exceeds what's seen in similar antibiotics, the memo stated. The contents of the May 16 memo were first reported Friday by the Wall Street Journal.
The memo suggests the FDA consider restricting the use of Ketek, or even withdrawing it, should the liver failure rate rise to levels seen in another antibiotic, Trovan, before its use was restricted in 1999.
FDA spokeswoman Susan Bro said it would be "premature" to discuss any steps the agency might take. The current FDA-approved label for Ketek warns of liver dysfunction that can be severe but is "usually reversible."
Final Government Approval Given to Barley Health Claim
The U.S. Food and Drug Administration announced Friday that it has finalized a qualified health claim for an association between foods that contain whole grain barley and a reduced risk of coronary heart disease.
Permission to make that qualified health claim applies specifically to whole barley and dry milled barley products such as flakes, grits, flour, meal and barley meal that provide at least 0.75 grams of soluble fiber per serving, according to a statement from the FDA.
Under an interim final rule, the FDA began allowing the claim in December 2005 while at the same time accepting public comments on the rule for 75 days. There were no comments received that warranted changes to the final rule.
Scientific evidence indicates that including barley in a healthy diet can lower levels of LDL ("bad") cholesterol and total cholesterol and help reduce the risk of coronary heart disease, the FDA said.
Remicade Approved to Treat Children with Crohn's Disease
The drug Remicade (infliximab) has been approved to treat children with active Crohn's disease, the U.S. Food and Drug Administration announced Friday.
Remicade is a genetically engineered monoclonal antibody that reduces Crohn's related inflammation of the bowel by blocking the action of tumor necrosis factor-alpha (TNF-a). The drug was initially approved in 1998 to treat Crohn's disease in adults.
The approval is based on the results of a study of 112 children, ages 6 to 17, with moderately to severely active Crohn's, who had poor response to conventional therapies. The number of children in the study who responded favorably to the drug was similar to that seen in an earlier study in adults with Crohn's. The children's study did not reveal any new safety concerns that are not currently listed on the drug's label, the FDA said.
There have been no satisfactory treatments for children with Crohn's disease who have moderate to severe disease activity and do not respond to conventional therapy, noted Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
"Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy," he said in a prepared statement. "We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated."
Surgical Plugs in Ears Stop Severe Dizziness
Surgery that plugs up a threadbare layer of bone in the inner ear can stop a debilitating and rare syndrome known as superior canal dehiscence, Johns Hopkins researchers report.
People with the syndrome lose their balance, and can't read or sleep due to loud noises inside their head. Some become convinced they are mentally ill, the researchers noted.
The condition occurs in men and women equally and is often not diagnosed until after age 40, when symptoms appear to worsen.
"The surgical plugging procedure can put a stop to even severe symptoms and can lead to a return to normal daily activities and, in some cases, to a mild-to-moderate improvement in hearing," said Dr. Lloyd B. Minor, director of otolaryngology-head and neck surgery at Hopkins. Minor first described superior canal dehiscence, and developed the surgical techniques to repair it, in 1998.
Minor's surgical team will present its findings from a decade's worth of research this week at the Combined Otolaryngological meeting, in Chicago.
In a pair of reports that provide the largest follow-up analysis of patients after their surgery for the syndrome, Minor's team found that plugging the superior canal where the bone casing is thin stopped the syndrome from recurring.