Asthama Drugs Get New FDA Regulations
February 19th, 2010 - 8:50 pm ICT by GDBy Meena Kar
Feb 19, (THAINDIAN NEWS) The US Food and Drug Administration (FDA) in its bid to reduce the risk of death and serious health injury to the asthma patients has decided to provide some regulatory guides for the use of asthma drugs. In its list of drugs which should be used with care in treating patients suffering from asthma, both children and adults is the GlaxoSmithKline’s asthma drug “Advair”, “Serevent”, AstraZeneca Plc’s “Symbicort” besides Novartis and Merck& Co’s “Foradil”.
According to the US Food and Drug Administration officials, the Long-acting beta agonists (LABAs) which helps the patients to recover fast from their asthma symptoms can lead to further exaggeration of the problem and even cause death. The drug according to them should be used with other asthma treating medicines and not alone. FDA’s clinical tests have found allegedly that the use of such medication should be reduced. The FDA has urged the companies concerned to mark the labels of the medicines with a precautionary note which will inform the patient of the risk involved in the use of such medicine.
GlaxoSmithKline on its part has said that it does not agree with the findings of the report and that its medicines are safe to their knowledge. It claims that both “Advair” and “Serevent” are nor harmful and that their benefits are more than their harmful effects. It has claimed that in its own clinical test of the drugs over 18,000 patients, no death cases have been reported. The company which has been given 30 days time to agree with the conditions levied on it, has proclaimed that it will work with FDA to provide a final label to the products so that the patients do not suffer.
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