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How should you change treating your asthma patients, now that two commonly prescribed LABAs have been banned by the FDA?
In December, a panel of experts from the Food and Drug Administration recommended to ban two drugs from being used for asthma: salmeterol (Serevent) and formoterol (Foradil), both long-acting beta agonists (LABAs). But since the drugs are likely to remain on the market, what should you know about prescribing them – or switching your patients to another medication?
"No one should be on either one of those drugs as monotherapy," says Thomas Casale, MD, executive vice president of the American Academy of Allergy, Asthma and Immunology and a professor of medicine at Creighton University in Omaha, Neb. "It's okay for patients to be on them, if they're taking an inhaled corticosteroid as well, but not as monotherapy."
The FDA panel did approve the use of two other medications, fluticasone and salmeterol (Advair) and Budesonide and Formoterol Fumarate Dihydrate (Symbicort), which combine an inhaled steroid, along with the LABA.
Serevent and Foradil probably will not be taken off the market altogether, since they are also used to treat chronic obstructive pulmonary disease (COPD).
Casale says the bottom line is clear-cut.
"If they're on those drugs by themselves, they should be taken off, or an inhaled steroid should be added," he says. "And the easiest way to do that is to skip the Foradil and Serevent, and just give them Advair or Symbicort because you've got the combination in one device that makes it much easier for the patient."
The panel recommended unanimously to ban Serevent and Foradil for use by children, but left the issue of prescribing for adults murkier. They voted 17 to 10 against the use of Serevent, and 18 to 9 to ban Foradil for use with adults.
The panel said unanimously that Advair and Symbicort should remain on the market for adults. Symbicort is not approved for use in children, but the panel okayed its use for teenagers by 20 to 5. Advair was given the nod for adolescents by 23 to 3 and in children by 13 to 11.
At issue, says Casale, is that although physicians may prescribe the steroid along with the LABA, patients often stop using the steroid because the LABA gives them a type of "rush," making them feel better instantly. Patients don't feel anything with a steroid since it works over time to reduce inflammation.
Casale attributes the close vote to the controversy over whether or not LABAs hurt or help patients.
"If you look at the asthma death rate in the US, it's actually gone down since the introduction of long-acting beta agonists," says Casale.
However, he adds that there is other epidemiologic data indicating that LABAs may increase the death rate. The panel then had to question if there are times when LABAs do increase death rates – such as when used alone.
"I think that's why the FDA panel had problems trying to make a hard and fast recommendation – because everything is not quite as clear as you would expect," he says.
Casale says another issue – not addressed by the panel – is that physicians over-prescribe Advair and Symbicort. He recommends closely assessing the severity of patients' asthma -- and then following the NIH guidelines, before prescribing the more complex drugs.
"The majority of patients have mild asthma, and in those patients, you could use a relatively low-dose inhaled steroid, or a drug like Singulair," he says.
If the patient's asthma is more severe – or those medications don't work – then Casale recommends switching to Advair or Symbicort, as a second step.
Finally, when patients have continued difficulty, they should be sent to an asthma specialist. For children, Casale recommends family physicians always consult with a specialist.
"In children, we know that 80 percent or greater of them have allergies as a major trigger, so identification of those triggers and the appropriate consultation on how to decrease exposures or how to manage them better, would always be a good idea," Casale says.
In another change for asthma patients, starting Jan. 1, 2009, physicians must prescribe inhalers that use a propellant called hydrofluoroalkane or HFA, rather than chlorofuorocarbon, or CFC. But, the switch isn't simply a matter of a patient going to a drug store to pick up a new inhaler.
Casale says that physicians should be proactive in educating patients about the change:
1. Contact all your asthmatic patients to let them know about the change.
2. Tell them the change is taking place because CFCs harm the environment by destroying the ozone layer. HFAs are environmentally friendly.
3. Issue new prescriptions for all patients. They will not be able to use the refills on an old prescription to get the new type of inhaler.
4. Make it clear that there will be a price increase, so patients don't have sticker shock when they go to the pharmacy. Since many patients are used to getting generic albuterol inhalers, they will find a price discrepancy because the new inhalers are considered name-brand medications.
5. Educate patients on the "feel" of the puff. "Patients perceive a different plume when they activate these inhalers," explains Casale. "HFA is a little gentler, so you don't feel it as much. You'll have the same effects from the medication in the same time frame. It's just that the actual blast, when it hits your mouth, isn't quite as severe when you use these newer delivery devices." The taste may be somewhat different, as well.
6. Teach patients how to clean the device. HFA inhalers can become clogged if they’re not cleaned regularly.