Albion Monitor /News

Asthma Group Attacks Primatene Mist

by Frances Cerra Whittelsey

on this topic from the Allergy and Asthma Network
Would a person suffering the symptoms of a heart attack run to a drug store in the middle of the night to find a remedy instead of going to a hospital emergency room?

Of course not. But that, in fact, is what some asthma sufferers do, relying on non-prescription Primatene Mist to regain their ability to breathe. It's a decision that could cost them their life, asserts Nancy Sander, the president of the Allergy and Asthma Network, Mothers of Asthmatics, an educational group based in Fairfax, Virginia.

"A mild asthma cough can escalate to a life-threatening episode very quickly," said Sander in an interview. "And you never know which of your attacks will be life-threatening. Asthma is no more an over-the counter disease than heart disease, and it shouldn't be treated with over-the-counter medicine." Indeed, 17-year-old fashion model Krissy Taylor died in 1995 after using Primatene Mist. A pathologist's report indicated that Taylor had an undiagnosed case of asthma.

Sander has repeatedly asked the FDA to take Primatene Mist and similar products off the market
Once a relatively unusual disease that was not considered especially serious, asthma now afflicts more than 14.5 million Americans, and the death toll is rising at a dramatic rate, reaching 5,167 in 1993. Sales of over-the-counter asthma inhalers have been farily steady at about $80 million a year for the past few years, according to a spokesperson for Whitehall Robins, the Madison, New Jersey-based maker of Primatene Mist. Primatene dominates the market, although Bronchaid and some private-label products are also still available.

On behalf of her organization, Sander has repeatedly asked the U.S. Food and Drug Administration (FDA) to take Primatene Mist and similar products off the market. At FDA hearings on a proposal to redesign the labels of all over-the-counter drugs to make them easier to read and understand, Sander expressed support for the proposal. However, she insisted that better labeling will not prevent asthma sufferers from misusing Primatene or relying on it for management of their asthma instead of going to a doctor.

So far, the FDA has not agreed with her position. In 1994, FDA advisory committees recommended continued availability of Primatene Mist without prescription, concluding that it is safe and effective when used according to the label instructions. Whitehall Robins counters Sander's assertion by pointing to a market research survey of more than 300,000 households done by telephone and mail, which included some questions about Primatene. According to spokesperson Carol Dornbush, the survey "demonstrated that most Primatene Mist users have mild asthma and do not overuse this medication."

Epinephrine, its only active ingredient has unwelcome and potentially dangerous side-effects, raising blood pressure and causing the heart to race
Since the FDA committee reached its conclusion, more has been learned about asthma and the effectiveness of new treatment that can prevent asthma attacks and allow sufferers to live more normal lives. Primatene has been on the market since the early 1960's, and delivers a metered dose of epinephrine, its only active ingredient. Current medical treatment for asthma no longer includes use of inhaled epinephrine, more commonly known as adrenaline. This "fight or flight" hormone has unwelcome and potentially dangerous side-effects, raising blood pressure and causing the heart to race.

During an asthma attack, the airways in the lungs constrict, and the passageways become inflamed and clogged with thick, sticky secretions. Adrenaline restores breathing by relaxing the muscles around the airways in the lungs, but the effect is short-lived, lasting only 20 or 30 minutes. An attack can be triggered by cold weather, exercise, irritants in the air like cigarette smoke or soot particles, and other substances to which a person is allergic.

Today, doctors prescribe anti-inflammatory drugs to prevent or lessen the severity of asthma attacks, and work to eliminate sources of allergies. Patients are also equipped with new classes of quick relief medications (known as bronchodilators) to use when an attack occurs that have less severe side-effects than epinephrine, and give longer-lasting relief.

Dr. Norman Edelman, consultant to the American Lung Association, and Professor of Medicine at Stony Brook University Medical Center in New York, confirmed in an interview that epinephrine, "is no longer prescribed in inhalation form" because the "newer medicines are more selective, give better therapeutic effects with fewer side effects."

Earlier this year, the Second Expert Panel on the Guidelines for the Diagnosis and Management of Asthma released a report which stressed "the critical role of inflammation in asthma and importance of a physician/patient partnership in managing the disease," according to Dr. Shirley Murphy, chair of the Expert Panel. The panel established four classifications for asthma severity, and recommended that anti-inflammatory medications should be used daily by all asthmatics except those classified as having a "mild intermittent" form of the disease.

"You have to go against the labeling if you want to breathe," says Sander. "The drug sets people up for failure"
If doctors no longer prescribe epinephrine because newer drugs are better, asks Sander, why should an inferior treatment be available without prescription? Dornbush, of Whitehall Robins, says the company's survey "highlighted the fact that Primatene Mist users "are able to appropriately self-treat sporadic asthma symptoms with inhaled epinephrine."

Dr. Betty Wray, President of the American College of Allergy, Asthma and Immunology, said in an interview that "the only indication I can see for it (Primatene) would be where people might be in a strange city, and they might not be in enough distress to go to an emergency room which would cost them money, and they don't have their bronchodilators." However, when told that sales of non-prescription bronchodilators totaled $82 million last year, she said, "The sales suggest a lot of people are inclined to treat themselves, and that Primatene may be more misused than appropriately used. We certainly don't want people to think that using Primatene should be on-going treatment for asthma."

Sander rejects even the argument that Primatene should be available to travelers. An asthmatic herself, she says, "If you are having an attack, you should be going to an emergency room, number one, and number two, only those people who don't take their asthma seriously will not prepare for a vacation."

Furthermore, she points out that although the label for Primatene Mist warns that "excessive use may cause...adverse effects on the heart," each use gives only 20 or 30 minutes of relief. But the instructions for use say it should not be used again for "at least 3 hours." What happens if the asthma attack resumes sooner than that? "You have to go against the labeling if you want to breathe," says Sander. "The drug sets people up for failure."

Or worse, she says, including a possible heart attack if they have undiagnosed heart disease or diabetes (for example, there are an estimated 8,000,000 Americans with diabetes who do not know they have it, experts say), or if they know they have those diseases but have not read, or ignore, the rest of the label warnings.

Primatene's label cautions in tiny but bold type that the product should not be used by people who have diabetes, high blood pressure, heart disease and certain other conditions. Nor, it says, should it be used "unless a diagnosis of asthma has been made by a doctor." When Krissy Taylor died after using Primatene Mist, the safety of the remedy was widely questioned in news reports. A pathologist's report on the cause of Taylor's death blamed it on an undiagnosed case of asthma, and possibly an underlying, and undiagnosed heart condition. The report did not implicate Primatene directly, but there is no doubt that Taylor used the drug contrary to its label precautions.

"The majority of people who die of asthma are not severe asthmatics"
Asthma has penetrated recently into the national consciousness as a serious disease. It is the leading serious chronic illness of children, and the number one cause of school absences attributed to chronic conditions. It is also becoming more deadly. There were 5,167 deaths from asthma in 1993, up from 2,598 in 1979, an increase of 98.9 percent. More than one out of five of the deaths were among African Americans, although that group represents only 12.5 percent of the population. The prevalence of the disease is also rising, disproportionately among women and children. From 1982 to 1994, according to the American Lung Association, the rate rose 72.3 percent in children; 81.3 percent among women; and 41.6 percent in men.

There is a "lot of speculation" about why asthma is on the increase, said Dr. Edelman, but "no strongly supported theories." The recent announcement by President Bill Clinton that tighter air pollution control regulations would be issued was based in large part on concern that tiny soot particles in the air may be playing a role in asthma attacks.

Although treatment guidelines for asthma calling for use of preventive anti-inflammatories were first set down in 1991, many family practitioners and internists, are still not well-informed about them, according to Dr. Wray. She said that the American College of Allergy, Asthma and Immunology is planning a "large campaign" to promote awareness to both doctors and patients.

Sander's personal quest for information to help with treatment of her own three astmatic children, in fact, led her to start her organization, she said, with the mission of informing other families about the latest treatments for asthma. "The majority of people who die of asthma are not severe asthmatics," she says. "The people who believe asthma is no big deal, or is all in the head, these are the people who are at risk of death. Afterwards, the people around them say, 'If only we had known.' It's so incredibly sad."

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Albion Monitor September 8, 1997 (

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