Investigation and potential lawsuit against GlaxoSmithKline for its manufacturing, distribution and marketing of Advair Diskus, which is an oral inhaler used to treat asthma in patients 12 years of age or older.
In November 2005, the FDA requested that GlaxoSmithKline update the product labels on the Advair Diskus asthma medication to alert patients and healthcare professionals that the drug may increase the chance of severe asthma episodes, and potentially cause death when those episodes occur.
Advair Diskus was first approved by the FDA in 2000. The medication contains two drugs: fluticasone and salmeterol, which in combination with one another help to reduce swelling in the airways and open up air passages in the lungs. Salmeterol is part of a class of drugs known as long-acting beta-agonists (LABA). LABAs were originally developed to help relax the muscles in the lungs, however they have recently been linked with increasing the severity of asthma attacks. The following is a public health advisory released by the FDA that highlights a number of recommendations about the use of LABA medications: LABAs should not be the first medicine used to treat asthma. LABAs should be added to the asthma treatment plan only if other medicines are unsuccessful. Patients should not stop using LABA or other asthma medications that healthcare providers have prescribed to them unless they have specifically discussed doing so with them. Patients should not use LABA to treat wheezing. If wheezing persists while on LABA, patients are urged to contact their physician immediately. LABAs do not relieve sudden wheezing. Patients should always have a short acting bronchodilator medication accessible.
Based on their findings, the FDA proposed a number of changes to the Advair Diskus product label, stating that although LABAs decrease the number of asthma episodes, the medications may increase the severity of those episodes, which can potentially cause death. Additional documented side effects from the Advair Diskus asthma medication include: Severe asthma episodes; death; Immune system deficiencies resulting in a higher chance for infections; Lower bone mineral density; Glaucoma; cataracts; Slowed growth in children; Increased blood pressure; Difficulty speaking; Fast and irregular heartbeat; Allergic reactions including rash, hives and swelling of the face, mouth and tongue; Headache; Tremors; Nervousness.
Do not change medications without first consulting your doctor.
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