FDA Committee Recommends Pulling Primatene Mist

Jan. 24, 2006 — -- A U.S. Food and Drug Administration committee voted 11-7 today to recommend that certain over-the-counter asthma inhalers, such as Primatene Mist, be taken off the market over concerns that they contain chlorofluorocarbons that could harm the environment.

Chlorofluorocarbons have been associated with depleting Earth's ozone layer, which can in turn contribute to global warming and skin cancer. But another issue at hand, according to health experts, is that Primatene Mist may do patients more harm than good.

The recommendation now means that the FDA will vote whether to keep over-the-counter inhalers on the market, said FDA spokesperson Laura Alvey.

Primatene's manufacturer, Wyeth, issued a statement saying the company was "disappointed."

"The recommendation was clearly not in the best interests of patients who rely on an [over-the-counter] rescue option for acute asthma attacks," the statement said.

But critics say that Primatene Mist is not an effective asthma treatment.

The active ingredient in Primatene Mist is epinephrine, commonly known as adrenaline. Although this ingredient opens the airways of asthma patients, it can also have potentially serious side effects on the heart and blood vessels.

These side effects, in turn, can lead to increased blood pressure and palpitations, doctors say.

"I would argue that based solely on the [lack of] efficacy and harm of over-the-counter asthma inhalers to patients, that these products should be withdrawn from the market regardless of their contribution to the CFCs in the environment," said Dr. Ronald Ferdman at the Children's Hospital in Los Angeles.

According to Wyeth, 2 million people use the product in combination with other inhalers, and another 1 million use it alone. It generated about $43 million in sales last year.

Instead of Primatene Mist, physicians most often use a drug called albuterol to provide quick-acting relief to patients who suffer the symptoms of asthma. Doctors say that albuterol is much safer than Primatene Mist because it is longer-acting and has fewer side effects.

Asthma-management guidelines published in 2002 by the National Heart, Lung and Blood Institute did not include any over-the-counter inhalers. These guidelines help doctors make treatment choices.

However, pulling these products from the market could force patients who self-treat their asthma to obtain proper care from physicians, said Dr. John Murray of Vanderbilt University Medical Center.

"The real concern is letting people self-medicate their asthma and potentially get into serious trouble covering up the symptoms," Murray said. "If [Primatene Mist is] pulled from the market, the result would hopefully bring more asthmatics to seek appropriate medical care."

Dr. Clifford Basset, medical director at the Allergy and Asthma Care of New York, agrees these drugs can increase the risk of harm to patients.

"Over-the-counter asthma inhalers will delay proper ... treatment for asthma, which can be associated with fatalities," said Basset.

Unlike the common cold, asthma is a disease that needs specialized care, Ferdman said.

"Some diseases can be treated without the help of a doctor," he said. Asthma is not one of these."

Dr. Mark Wernick is with Beth Israel Deaconess Medical Center in Boston.