The safety of the drugs Serevent (Glaxo SmithKline PLC), Symbicort (Astra Zeneca PLC), Foradil (Novartis AG) has come under a cloud, with apprehensions persisting that the consumption may risk hospitalization and death in some asthma patients.
The clinical studies of long-acting beta agonists, known as LABA’s, showed a ‘positive risk difference’ which was ‘statistically significant’ for Serevent.
Advair the fourth drug does not appear to have serious respiratory complications. It is Glaxo’s biggest selling product having an annual sale worth 4 billion dollars. Advair that combines a steroid, to ward off serious respiratory complications, is used to treat underlying inflammation inside the airways. A meta analysis of studies found that risk ‘was not apparent’ when LABA was used with a steroid.
The FDA is skeptical about the long-acting medication which tends to relax tight muscles around the airways limiting the use of inhalers. The real problem is the risk of aggravating respiratory complications.
To analyze the clinical data on the drugs, the FDA has asked for a special two day meeting with outside advisers. The focus is to dissect the findings, hear the presentations by the drug makers and finally make recommendations if the drugs are fit for marketing.
All the four drugs carry strong warnings, but medical experts need to consider the hazards involved. Maybe the outcome of the meeting could lead to more specific instructions or greater restrictions on some medications.
The manufacturers of the drugs advocated that “the benefits outweighed the risks” if the medicine was used as directed. But they need to be mindful of safety reviews by the FDA and their potential commercial impediments.
Figures reveal that children between 4-11 years taking LABA drugs were prone to maximum risk. It was also more perilous for female users than their males and the African American were slightly more in danger than other groups.
Studies show that of the 20 asthma related deaths, 16 were patients using LABA drugs and the 4 others were taking non-LABA medications. The FDA clarified that, “All the asthma related deaths were among Serevent treated subjects.”
Dr Badrul Chowdhury, director of the FDA division reviewing pulmonary
define and allergy drugs, pointed to ‘serious and significant risk’ but believed that deaths due to asthma were very low whereas benefits were ‘not trivial’.
He further stated, “Removal of inhaled LABA’s from the market as a treatment for asthma is a way of managing the risk of these drugs but would be an extreme approach that could be problematic.”
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