Serious safety concerns about the asthma medications known as Long Acting Beta Agonists or LABAs surfaced in 2002. These drugs are used to make breathing easier for patients with asthma. The asthma medications available in Saudi Arabia containing LABA appears at the end of this article (see Table 1).

Because of growing concerns about the safety of LABAs the U.S. Food and Drug Administration (US-FDA) held a two day meeting of experts on December 10 and 11, 2008 to review the safety of these products. The experts were asked to consider if these drugs should be removed from the market or restrictions be placed on their use in asthma patients.

The safety analyses clearly showed that the use of LABs was associated with an increased risk of asthma-related death; asthma-related need for assisted breathing; and asthma-related hospitalizations. These risks were greatest in young children (age 4 –11) women, and African Americans. The analysis also documented that there is no protective effect of the LABS against asthma-related hospitalization and other asthma related serious outcomes.

The US-FDA team unanimously recommended withdrawal of the approval of all LABAs for patients less than 18 years of age. And withdrawing approval for asthma and warning against the use of Serevent and Foradil) for all ages. The safety reviewers were divided on whether or not all LABAs should be withdrawn from the market.

The advisory committee of outside experts voted that to continue Seretide and Symbicort and to remove Serevent and Foradil from the market.

The US-FDA has not reached a final decision on the marketing of the various LABA containing products in the US. The Saudi Ministry of Health is currently reviewing what actions should be taken in Saudi Arabia.

At this time the Saudi Food and Drug Authority (SFDA) recommends the following for the public:

Patients with asthma should not self medicate and should be treated by a qualified physician.

Do not stop or change your asthma medication without first consulting a qualified pharmacist or physician.

Patients who experience an asthma attack should seek medical attention immediately that can include going directly to the nearness hospital or clinic emergency department.

The recommended first line treatment for persistent asthma is inhaled corticosteroids. These drugs should be prescribed by a physician. A list of inhaled corticosteroids appears at the end of this article (see Table 2).

The LABA containing products should not be used to treat the respiratory symptoms of allergy or seasonal hayfever.

Table 1: Asthma medications available in Saudi Arabia containing LABA.

Table 2: A list of inhaled corticosteroids available in Saudi Arabia.

                                                                                                     National Drug and Poison Information

                                                                                                                Food and Drug Authority