Glaxo's Asthma Drugs May Harm Children, U.S. FDA Staff Says
Pastor Dale Morgan
Glaxo's Asthma Drugs May Harm Children, U.S. FDA Staff Says*
By Michelle Fay Cortez and Lisa Rapaport
Nov. 25 (Bloomberg) -- GlaxoSmithKline Plc's asthma drugs Serevent and
Advair, the company's biggest-selling medications, may have rare and
deadly side effects for children, safety officials at the U.S. Food and
Drug Administration said.
Nine patients under age 16 were harmed, including five who died, while
taking Serevent in the 13 months after it was approved in the U.S. for
children in 2006, a safety review found. An advisory panel of
pediatricians is slated to discuss side effects from Serevent and other
medications on Nov. 27.
The FDA strengthened the warning labels for Serevent, Advair and
Novartis AG's Foradil almost two years ago, limiting use to patients who
don't benefit from other drugs. A study found patients using Serevent
had a fourfold increase in asthma- related deaths, while others showed
it and Foradil increased asthma exacerbations and hospitalizations in
adults and children, according to the FDA staff memo Oct. 24, 2007.
``There is no available pediatric data to indicate that the increased
risk of asthma death and life-threatening exacerbations observed in
adults does not also apply to children,'' the FDA staff members wrote in
a report posted on its Web site today. While the review didn't identify
any adverse reactions unique to children, Serevent may have more risks
than benefits for the youngest users, they said.
Glaxo officials weren't immediately available to comment.
The drugs are used long-term to relax the airway, control symptoms and
prevent exacerbations of asthma. Almost one in 10 Americans will be
diagnosed with asthma at some time, according to the National Institutes
of Health. About 21 million adults and 9 million children in the U.S.
currently have the condition.
Global Revenue
Global revenue for Serevent and Advair rose 12 percent to $6.13 billion
last year, making the medicines the second-best- selling in the world
behind Pfizer Inc.'s cholesterol drug Lipitor. Advair is a combination
of the salmeterol, the chemical in Serevent, and a steroid.
Asthma is a chronic respiratory disease that causes inflammation and
narrowing of airways in the lungs. Asthma attacks can be caused by
changes in the weather, allergies, exercise, smoking or exposure to
toxic air. Attacks can cause shortness of breath, cough, chest pain and
other symptoms.
The FDA staff members said a study looking at the drugs' safety may be
warranted, thought it would be difficult to enroll enough children. A
more ``formal'' analysis of their risks and benefits in treating asthma
in children is needed, they said.