Press releases

Released May 16, 1997
Yale-New Haven Hospital news release

New Medications for Asthma
Must Comply With FDA Regulations

For more information, call 203-688-2488 or E-mail Ken Best

The Food and Drug Administration (FDA) announced plans recently to conduct a major overhaul of inhalers used by as many as 24 million Americans with asthma and upper respiratory disease. The plan calls for phasing out inhalers which use chlorofluorocarbon gases, or CFC, as a propellant to spray out a fine mist of medication that is inhaled through a mouthpiece. The phasing out is mandated by the 1987 Montreal agreement signed by 150 countries and attempts to abandon CFC propellant in order to protect the ozone layer.

FDA officials reported that the switchover will take years to accomplish. "We're not proposing to eliminate CFCs until new products adequately serve patients' needs," according to Dr. John Jenkins, director of the division of pulmonary drug products at the FDA.

Dr. Gabriel Haddad, chief of the section of respiratory medicine at Yale-New Haven Children's Hospital and director of the hospital's asthma clinic, said, "The switchover to the CFC-free medication is an important step in abiding by the Montreal agreement to protect the ozone layer. It has the support of the American Lung Association. However it is essential to ensure that medications are on the market before the FDA phases out the current CFC-propelled medications."

Dr. Haddad agreed with consumer groups that adequate testing for effectiveness and affordability both need to be considered by the FDA before implementing these changes. "If we require a switch to new medications and delivery systems and the cost leaps beyond the means of many patients to pay, then I would find these proposals troubling."

However, Dr. Haddad continues: "The good news is the appearance of new medications that are not CFC medications but which are ozone-friendly medications such as the HFA-Poventil (or albuterol) for asthma patients which have the same effectiveness as previous ones."

Creating new inhalers is slow and expensive because of the complex nature of the devices. Each drug requires its own system to be sure that it delivers the correct dose, in particles of the correct size, to the correct part of the lung, every time. New propellants have to be proven safe for inhalation. Every new product must pass the FDA new-drug approval process, even if the active medication has been used before.

According to Dr. Haddad there are tens of thousands of asthma sufferers in Connecticut with symptoms ranging from minor to life-threatening. The disease is particularly troubling because is usually manifests itself for the first time in children. The clinic at Yale-New Haven, with five pulmonary subspecialists and two full-time nurses, follows over 1,000 children from throughout Connecticut. The program sees patients on Tuesdays, Thursdays and Fridays each week in the Specialty Center of the Children's Hospital.

"Appropriate asthma care should prevent serious attacks and troublesome symptoms day and night, minimize the need for quick relief medication and avoid medication side effects," Dr. Haddad said.

May is National Asthma Awareness month. For information on the causes of asthma and steps to take to control the respiratory ailment, call Yale-New Haven Children's Hospital at 785-2480.

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