The Food and Drug Administration (FDA) approved GlaxoSmithKline's Serevent in 1994 for the treatment of asthma-related symptoms. Subsequently, the FDA approved Serevent as a treatment of chronic obstructive pulmonary heart disease. Shortly after the drug's approval, concerns over Serevent's safety arose. A number of participants in a 1996 clinical study of Serevent experienced severe asthma episodes, some of which resulted in the individual's death. As a result, the FDA requested GlaxoSmithKline to place a "black box" warning, the FDA's highest cautionary label, on Serevent packaging and marketing materials by December of 2003. Beyond making this request, the FDA has taken no further action to address the safety concerns surrounding Serevent. GlaxoSmithKline has refused to comply with the FDA's labeling request, thus the drug remains on the market without the warnings deemed necessary by the federal government.
Despite the severe and fatal asthma attacks experienced by participants in the 1996 clinical studies of Serevent and the FDA's insistence that GlaxoSmithKline feature black box warnings on Serevent, this drug remains on the market as a potentially life-threatening drug. If you or a loved one has taken Serevent, also known as Serevent Diskus and salmeterol xinafoate inhalation powder), we will evaluate your case absolutely free. If Serevent has injured you or a loved one, our legal team will aggressively fight for your rights. You may be entitled to compensation.