FDA Officials Differ Over Asthma Drugs' Risks
Two members of the U.S. Food and Drug Administration said Friday that people with asthma risk serious respiratory problems -- and even death -- if they continue to use four popular asthma drugs -- Advair, Symbicort, Serevent and Foradil, The New York Times reported.
But not all members of the FDA share that view. The agency has called a special two-day meeting of outside advisers for next Wednesday and Thursday to discuss data on the drugs and make recommendations on their use.
The two officials, who work in the FDA's safety division, posted an assessment on the agency Web site on Friday, saying asthma sufferers of all ages should not take the medicines. But a third FDA official concluded that Advair and Symbicort are safe for adults, but that all four drugs should no longer be used by children 17 and younger, the Times said.
Dr. Badrul A. Chowdhury, head of the FDA's division of pulmonary and allergy products, said his assessment found that the risk of death connected with the drugs was small, and that banning their use "would be an extreme approach" that could lead asthmatics to rely on other risky medications, the newspaper said.
The Associated Press said the drugs, known as long-acting beta agonists (LABAs), already carry the FDA's strongest warnings on their labels. The medicines relax tight muscles around constricted airways, freeing asthma suffers from the need to take a puff from their inhaler every few hours. For many people with asthma, that means they can sleep through the night.
But for reasons still unclear, LABAs can increase the risk of death and respiratory complications in some patients. Those risks might be reduced if an LABA is used in tandem with a steroid to treat underlying inflammation in the airways. Current medical guidelines suggest using both kinds of drugs together for patients with chronic asthma who aren't responding well to other treatments, the AP said.
Dr. Katharine Knobil, global clinical vice president for GlaxoSmithKline, which markets both Advair and Serevent, told the Times that the FDA's drug-safety division findings weren't "supported by their own data." She said Advair was safe and Serevent was safe when used with a steroid.
Michele Meeker, a spokeswoman for AstraZeneca, which makes Symbicort, said the FDA's safety division improperly excluded most studies of Symbicort in its analysis. A review of all the data shows the drug doesn't increase the risks of death or hospitalization, she said, according to the Times.
Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics's committee on drugs, said he treats children with Advair, and his committee had recently discussed the safety of the medicines.
"Most of us felt these were pretty good drugs. I'm really looking forward to hearing what the FDA committee decides," he told the newspaper.
Asthma is a chronic disease that can cause the airways to constrict, reducing airflow to the lungs. This can lead to wheezing, coughing, chest tightness and trouble breathing. Severe asthma attacks can be fatal, according to the U.S. National Library of Medicine.
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WHO Sets Standards for Melamine Contamination in Foods
Responding to mounting global concerns, the World Health Organization on Friday issued safety limits for levels of melamine in foods. The industrial chemical should not be present in baby formula, but trace levels are unavoidable in some foods, especially those consumed by adults, according to published reports.
Melamine has been blamed for sickening nearly 300,000 children in China and may have caused six deaths, Agence France-Presse reported.
Friday's action marks the first time the United Nations-affiliated agency has set safety limits for the chemical, which is used in the production of plastic products. WHO officials stressed, however, that melamine "should not be in food," even though traces are sometimes unavoidable, the news service said.
Melamine can cause kidney stones if consumed in excessive levels; in severe cases, it can cause kidney failure. The chemical has been routinely mixed into Chinese milk and dairy products to boost protein content.
Jorgen Schlundt, the WHO director for food safety, said the Tolerable Daily Intake (TDI) threshold states that a 50 kilogram (110-pound) person could tolerate 10 milligrams of melamine a day. This is not a "safe" level, but rather the amount a human being can consume without higher health risks, Schlundt said, according to the Associated Press.
"The TDI is meant to help national authorities set safe limits in food for withdrawal purposes should melamine be detected as a result of intentional adulteration," added the WHO.
The melamine scandal has prompted many countries around the world, including the 27-nation European Union, to ban Chinese milk imports, AFP said. The United States has put in place an import alert that requires importers to prove that Chinese milk products are melamine-free.
Last month, the U.S. Food and Drug Administration announced an allowable threshold of 1 part per million of melamine in baby formula. The FDA had originally said that no levels of the chemical were acceptable.
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Alzheimer's Drug May Help Brain Cancer Patients
An experimental Alzheimer's drug may be effective against highly aggressive brain tumors called malignant gliomas that are resistant to conventional treatments, according to Canadian researchers.
The University of Calgary team identified a "switch" activated by a protein already present in the brain that enables cancer cells to spread from the primary brain tumor. The Alzheimer's drug prevents that switch from being turned on, CBC News reported.
The study was published in the journal PLoS Biology.
"Several drug companies have already invested hundreds of millions of dollars in developing drugs that target this process, although in Alzheimer's, not in cancer, so it's sort of a new way to think about it, and we have a leg up where we could make an impact," oncology professor Dr. Peter Forsyth told CBC News.
Clinical trials to test this treatment on brain cancer patients in Alberta could begin within a few years, he said.
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Bed Sore-Related Hospitalizations Up 80%: Report
Between 1993 and 2006 there was an 80 percent increase in hospitalizations for pressure ulcers -- better known as bed sores, according to the latest News and Numbers from the U.S. Agency for Healthcare Research and Quality.
The agency's analysis of data from the Nationwide Inpatient Sample found that of the 503,300 pressure ulcer-related hospitalizations in 2006:
- Pressure ulcers were the primary diagnosis in about 45,000 hospital admissions, compared to 35,800 in 1993.
- Pressure ulcers were a secondary diagnosis in 457,800 hospital admissions in 2006, compared to 245,600 in 1993. Most of these patients were admitted for pneumonia, infection or other medical problems and developed pressure ulcers before or after hospital admission.
- Death occurred in about one in 25 of cases in which pressure ulcers were the primary diagnosis, and in about one in eight cases in which pressure ulcers were a secondary diagnosis.
- Pressure ulcer-related hospitalizations last longer and cost more than many other hospitalizations. The overall average hospital stay is five days and costs about $10,000. The average pressure ulcer-related hospital stay is 13 to 14 days and costs $16,755 to $20,430, depending on medical circumstances.
Bed sores typically occur among patients who can't move or who have lost sensation. Older patients, stroke victims, and people who are paralyzed, have diabetes or dementia are at high risk for bed sores.
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