Black box warnings about asthma medications such as Xolair and Advair seem to be in the news a lot lately. Should you be concerned about such black box warnings? Are the risks of taking these medications too high?
- All medicines can potentially cause side effects. Not everyone will have these side effects, and most of them are mild and go away over time as you get used to a medicine.
- A black box warning is language required by the FDA that drug manufacturers must put on drug packaging. It is usually used to warn of serious, though often uncommon, side effects. The text is outlined in a black box.
- When prescribing a medication, the doctor must always weigh probable benefits for the patient against any potential risks. Some degree of risk may be considered acceptable, if it will keep the patient healthier over the long run.
- When a drug that has a black box warning is still being sold, that means that it hasn't been deemed dangerous enough for its use to be banned entirely.
The asthma medication that originally received a black box warning was Serevent (salmeterol), a long-acting beta agonist (bronchodilator, or LABA for short). It got the warning as a result of studies showing that when people with asthma took it by itself as asthma treatment, they sometimes died from asthma-related causes. The combination inhaler Advair also received the warning because it contains Serevent, along with an inhaled steroid named Flovent (fluticasone).
However, subsequent studies suggest that some of the serious events that occurred to people taking Serevent may have been more related to the fact that LABAs are not very effective on their own in controlling asthma. Because their asthma was not well-controlled, the patients were more likely to have serious asthma attacks. When LABAs are added to inhaled steroids, as they are in Advair and Symbicort (Pulmicort and Foradil), asthma control and serious side effects are rarely problems.
In theory, taking Advair and Symbicort should not be that risky, especially when weighed against the risk of uncontrolled asthma. But your doctor is the best one to talk to about any concerns you may have along those lines.
In the case of Xolair, a type of asthma medication called an immunomodulator, the black box warning it received had to do with severe allergic reactions, known as anaphylaxis, that about 1 out of every 1,000 patients has when taking Xolair.
Singulair has also received much attention because of the possibility that it increases the risk of suicide, though no black box warning is in place yet. A joint statement by the American Academy of Allergy Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI) states that there is "no data from well-designed studies to indicate a link between Singulair and suicide. The concern expressed by the FDA is based entirely on case reports, and there is no indication that such effects apply to other leukotriene-modifying medications."
They go on to recommend that people with asthma and allergies continue to take Singulair as prescribed, provided you and your doctor are in agreement that this is the best course of treatment for you and that you are on the watch for any signs of depression or thoughts of suicide.
The Bottom Line
It's important to remember that stories you seen in the media will often overemphasize the negatives of any issue, because that is what makes for interesting news. But what you won't necessarily hear about are the tens of thousands of people with asthma who are helped by these medicines, without having any serious side effects. So keep things in perspective and discuss your questions or concerns with your doctor. Also, watch the pages of the About.com Asthma Blog for updates, as they occur.
Sources:
"Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma." NHLBI Guidelines for the Diagnosis and Treatment of Asthma. 28 Aug 2007. National Heart Lung and Blood Institute. 18 Dec. 2007 <http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf>
"Advair Diskus, Advair HFA, Brovana, Foradil, Perforomist, Serevent Diskus, and Symbicort Information." 01 04 2008. U. S. Food & Drug Administration. 30 Apr 2008
"Early Communication About an Ongoing Safety Review of Montelukast (Singulair)." 27 03 2008. U. S. Food & Drug Administration. 30 Apr 2008
