Health Highlights: May 10 2013
Judge Refuses to Put Hold on Order for Wider Access to Emergency Contraceptive Avoid Juices Incorporated Products: FDA New COPD Drug Approved by FDA 3 Suspected Cases of SARS-Like Virus Reported in France U.S. Lawmakers Investigating Stimulant in Workout Products
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Judge Refuses to Put Hold on Order for Wider Access to Emergency Contraceptive
A federal judge has refused to put on hold his order giving the Food and Drug Administration 30 days to lift age limits and other restrictions on the sale of the Plan B emergency contraceptive.
The Obama administration plans to appeal the decision handed down last month by U.S. District Judge Edward Korman in Brooklyn, N.Y. and asked him to put his order on hold until the appeal is heard, The New York Times reported.
But Korman said Friday he would give the government until noon on Monday to seek a stay from the U.S. Second Circuit Court of Appeals.
"The motion for a stay pending the appeal is denied. Indeed, in my view, the defendants' appeal is frivolous and is taken for the purpose of delay," Korman said in a 17-page order, The Times reported.
Avoid Juices Incorporated Products: FDA
Consumers should not drink carrot and beet juice products made by Juices Incorporated of Brooklyn, N.Y. because the juices may be contaminated with bacteria that cause botulism, the Food and Drug Administration says.
Botulism is a serious and potentially fatal illness caused by Clostridium botulinum. Even if the juices do not look or smell spoiled, consumers should not drink them, the FDA said.
The agency said the following Juices Incorporated juice products pose a particular concern for Clostridium botulinum contamination: Carrot Juice Drink; Carrot & Beet Juice Drink; Carrot & Ginger Drink; Double Trouble Carrot Punch; Ginger Beet Juice; and Beet Juice Drink.
The products are packaged under the brand names Juices Incorporated, Juices International and Juices Enterprises. The products were previously distributed in New York, New Jersey, Connecticut and Pennsylvania, but were recently found in stores and restaurants in the New York City area, and consumers may have transported the products beyond this region, the FDA said.
New COPD Drug Approved by FDA
A new drug called Breo Ellipta has been approved to treat chronic obstructive pulmonary disease (COPD), the U.S. Food and Drug Administration said Friday.
COPD is a serious lung disease that worsens over time and is the third leading cause of death in the U.S.
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) has been approved for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
The approval is based on a study of 7,700 patients. It found that those treated with Breo Ellipta showed improved lung function and reduced exacerbations compared to those who received a placebo. The drug works by decreasing airflow in the lungs and helping muscles around the airways of the lungs stay relaxed in order to increase airflow, the FDA said.
The drug is not approved for the treatment of asthma and carries a boxed warning about an increased risk of asthma-related death. Serious side effects associated with the drug include increased risks of pneumonia and bone fractures. The most common side effects include inflammation of the nasal passage, upper respiratory tract infection, and headache.
3 Suspected Cases of SARS-Like Virus Reported in France
Three new suspected cases of people with a deadly new SARS-like virus are being investigated by health officials in France, and a 65-year-old man confirmed to have the virus remains in hospital.
The man became ill after returning from Dubai on April 17 and was hospitalized on April 23. A nurse, doctor and former hospital roommate who had contact with the man are in hospital and their test results are expected later Friday, the Associated Press reported.
There have been 30 confirmed cases of the new SARS-like coronavirus since September 2012 and 18 of the patients have died, according to the World Health Organization.
Cases have been reported in Saudi Arabia, Jordan, the United Arab Emirates, Qatar, Britain and Germany. Health officials say the virus has likely spread from person to person in some cases, the AP reported.
U.S. Lawmakers Investigating Stimulant in Workout Products
An inquiry into the safety of an amphetamine-like substance in some popular workout and fat-burning products sold at GNC stores has been launched by U.S. lawmakers.
The products contain a stimulant called dimethylamylamine (DMAA), which the Food and Drug Administration believes is an illegal dietary supplement ingredient. Last month, the agency warned consumers that DMAA was potentially dangerous, The New York Times reported.
Products that contain DMAA include Jack3d and OxyElite Pro, made by USPlabs.
In letters sent Wednesday, three Republican members of the oversight subcommittee of the House Committee on Energy and Commerce sent a letter to GNC -- the nation's largest dietary supplement chain -- asking why products containing DMAA were still for sale, The Times reported.
"FDA issued a consumer safety alert noting that the agency had received 86 adverse event reports associated with products containing DMAA, including psychiatric disorders, heart problems, nervous system disorders and deaths," the letter stated. "However, as of May 7, 2013, GNC continues to sell Jack3d on its Web site."
The lawmakers also sent letters to the FDA and USPlabs. Last month, USPlabs said it was phasing out the original Jack3d and OxyElite Pro products containing DMAA. GNC continues to sell both products and a spokeswoman said the company "has no reason to believe that DMAA is unsafe," The Times reported.