Warnings to be added about risk of Serevent and Advair problems for children
A panel of medical experts met yesterday and recommended that the FDA take prompt actions regarding problems with Serevent and Advair. The asthma inhalers could increase the risk of death or severe asthma attacks when taken by children. The panel of outside experts was convened by the FDA following reports of a number of deaths and hospitalizations associated with the drugs.
>>INFORMATION: Serevent and Advair Lawsuits
The FDA advisory panel met to review the safety of salmeterol, which is the active ingredient in Advair and Serevent. The medications are part of a class of drugs known as long-acting beta agonists, approved for use in adults and children to treat asthma. While the drugs can reduce the frequency of asthma attacks, they also could significantly increase the severity of the attacks, leading to hospitalization or death.
The Serevent and Advair problems were called an “urgent public health issue” during the meetings, and the FDA has been urged to move forward soon with stronger warnings and a new safety review. The director of the FDA’s office of pediatric therapeutics indicated that they will review the drugs, but that they do not believe a Serevent or Advair recall are appropriate at this time, or that the asthma drugs should be limited to only adults.
Asthma is a serious health concern for children, as it is one of the most common chronic diseases. According to the U.S Centers for Disease Control and Prevention (CDC), approximately 9% of all children in the United States have asthma, which is about 6.5 million children. However, many question whether the clinical benefits of Advair and Serevent justify exposure to the risk of death and asthma-related hospitalizations.
Following a similar FDA advisory panel meeting in 2005, a “black box” warning was added to both of the drugs last year, which indicates that Serevent and Advair may increase the risk of asthma-related death. The “black box” warning is the strongest warning that can be placed on a prescription medication, but the panel which met today urged the FDA to add more specific language which would apply to children and to indicate the risk of asthma-hospitalizations. In addition, they requested prominent indication that the drugs should not be used alone, without other drugs designed to control acute asthma attacks.
Both drugs are manufactured by GlaxoSmithKline, PLC, who said that they believe the current warnings are sufficient. However, the panel of medical experts disagreed, feeling that the current label does not do enough to warn about the Serevent and Advair problems which could be caused when used by children. At least two panel members felt that the risk of injury and death was so great that a Serevent recall should be considered.
Advair contains the same active ingredient as Serevent, but adds a steriod. The popular combination drug generated sales of $6.8 billion worldwide last year. While some suggested that the steriod in Advair protects against the side effects of Serevent, the FDA advisory panel rejected that idea. They indicated that there is no evidence that the steriod reduces the risk of asthma-related deaths from Advair.
SEREVENT AND ADVAIR LAWSUITS
The lawyers at Saiontz, Kirk & Miles, P.A. are reviewing potential Serevent and Advair lawsuits for users of the inhalers who suffered an asthma-related death which could have been caused by the medication. Cases are being reviewed nationwide. If you believe that a friend or family member’s death may have been caused by their use of Serevent or Advair, request a free lawsuit evaluation.
