OTC and under the FDA's scope

February 1, 2008

FDA to ban OTC asthma inhalers by 2010 and a look at how OTC drugs affect teens

• Is a greener world worth keeping OTC asthma inhalers off the shelves?

Over-the-counter (OTC) epinephrine metered-dose inhalers are obviously not a well-recommended treatment for asthma, as compared to prescription medications. But according to marketers' data an estimated 1.7 to 2.3 million people with asthma use them, including many children.

The Food and Drug Administration may allow them to be forced off the market three years from now, perhaps for up to a year. The questions arise as to how many of those patients would be better off, since they would see physicians and obtain prescription medications, and how many would be worse off, since they would turn to caffeine or herbal products for help with their asthma. The FDA is considering those questions in the wake of its phasing out of a medication exemption for chlorofluorocarbons. The propellant substances were found to be thinning the ozone layer in the stratosphere in the 1970s.

At the December 5 hearing at the FDA's Rockville, Md., offices, Armstrong counsel Robert Sussman said that some of the product's users do not have access to health care or prescription products. "We recognize that epinephrine MDI (metered-dose inhaler) is not the drug of choice for physicians treating asthma patients," Sussman said. "Nonetheless, this product serves a vital role in serving this patient population."

However, the Allergy and Asthma Network Mothers of Asthmatics asked the agency not to extend the deadline, saying that people using the OTC product should switch to prescription products, anyway. That association testified that 92% of physicians surveyed at the meeting of the American Academy of Pediatrics said they did not recommend OTC inhalers to their patients. In addition, 55% agreed with the statement: "OTC epinephrine inhalers are outdated therapy-the duration of action is short-lived and has unnecessary cardiac stimulation."

FDA cites information from Wyeth Consumer Health, marketers of Primatene Mist, that one third of OTC epinephrine MDI users use it solely, but two-thirds use it along with prescription drugs for the condition. The group acknowledged that there would be a serious, and possibly dangerous, transition challenge, with some "unique concerns" about educating OTC users.

Officials have talked about physicians, pharmacists and other health care professionals educating patients. But because the product is over-the-counter, its purchasers may not interact with health care professionals. Other users may need help or extra time to visit a physician. One study showed that less than 25% of children and adolescents use their metered-dose inhalers correctly.

The agency noted, "We also believe that utilization of programs providing low-cost or free prescription drugs may reduce, but not eliminate, the number of people with asthma facing barriers to health care who depend on OTC epinephrine MDIs." OTC epinephrine itself cost about $13 per inhaler. Prescription drugs obtained through low-cost drug plans could actually cost less.

In a related issue, the FDA may also withdraw the CFC exception for several prescription inhalants by the end of 2009. Those products would be off the market if they do not reformulate without CFCs. Some pediatric specialists opposed the rule, saying the products are needed for patient subsets. Those medications include products containing flunisolide (AeroBid), triamcinolone (Aristocort), metaproterenol (Alupent), pirbuterol (Maxair Autoinhaler), albuterol and ipratropium in combination (Combivent), cromolyn (Intal), and nedocromil (Tilade).

Background on the OTC MDIs can be found in the September 20, 2007, Federal Register, or can be accessed at http://www.gpoaccess.gov/. Information on the prescription inhalants proposed rule appears in the June 11, 2007, edition.

• Adolescents and OTC drugs

Children aren't just little adults-and neither are adolescents. But adolescents have the same access to over-the-counter drugs as adults.

Do all OTC drugs work the same in adolescents as in adults? Are adolescents mature enough to use these medications wisely? How likely are they to abuse OTC drugs? In a December workshop in Bethesda, Md., the FDA gathered information on adolescent research for consumer studies of OTC drugs.