FDA issues warning on asthma meds

The US government is taking steps to curb use of some long-acting asthma drugs used by millions, issuing safety restrictions to lower a life-threatening risk that asthma could worsen suddenly.

The Food and Drug Administration's warnings cover the drugs Advair, Symbicort, Foradil and Serevent. The FDA said they should be used only by asthmatics who cannot control their lung disease with other medications - and even then only for the shortest time possible.

Nor should LABA-containing drugs ever be used without simultaneous use of a different asthma-controlling medication, such as an inhaled corticosteroid - a move that specifically targets two of the drugs, Foradil and Serevent, the FDA said.

Masks inflammation

Why? These four drugs contain an ingredient that relaxes muscles around stressed airways, called a long-acting beta agonist or LABA. While they're very helpful for some patients, the way LABA-containing drugs work also sometimes masks that inflammation is building in the airways. That means patients may not realise a serious asthma attack is brewing until they're gasping for air.

Advair and Serevent are marketed by the British firm GlaxoSmithKline, Foradil by the Swiss company Novartis AG and Symbicort by AstraZeneca, which is Anglo-Swedish.

Increased risk of hospitalisation, death

The FDA cited studies that showed an increased risk of hospitalisation and even some deaths, particularly among children.

One study found three extra adverse events - mostly hospitalisations - for every thousand patients who took a
LABA-containing drug compared to another asthma medication, said FDA's Dr Gerald Dal Pan.

Medical guidelines already urge people to use a LABA together with an inhaled corticosteroid to relieve inflammation. Advair and Symbicort combine both kinds of medicine in one inhaler. Over a year ago, the FDA's scientific advisers had urged that LABA-only medications, Foradil and Serevent, no longer be used to treat asthma - and that none of the four drugs be used in children.

Stricter regulation

The FDA said Thursday it was taking a somewhat stronger step. It can't pull those medications off the market because people with other lung diseases, such as chronic obstructive pulmonary disease or COPD, use them without the asthma risk. Just saying they shouldn't be used for asthma would have little practical effect, said Dr John Jenkins, FDA's director of new drugs. So FDA labeled LABA-containing medications as contraindicated without simultaneous use of a different asthma-controlling medication - a legal term with more enforcement muscle to limit prescription. FDA will monitor that, to see if doctors follow the rules.

"Our goal is to overall reduce the use of LABAs, to manage the risk while at the same time keeping them available for those patients who really need them," said Jenkins, a pulmonologist.

"The reality is the available options to treat asthma are not that great," he added. For patients not well-controlled by inhaled corticosteroids alone, "their options for additional therapy are, in and of themselves, drugs with a lot of risk."

Other warnings:

• Quit LABA-containing drugs as soon as asthma is brought under control, in favour of a corticosteroid or other asthma-maintenance medicine.
• Children and teens should be prescribed only the combination LABA drugs to ensure compliance with both medications. That mostly happens today, as paediatric use of the single-agent drugs has plummeted with publicity about the risk.
• Manufacturers also will be required to study whether
  combination LABA use indeed lowers the risk.

- (Sapa, February 2010)