Asthma Drug’s Possible Risks Cited : Medicine: A lawyers’ group says theophylline can cause death. One manufacturer calls the warning a ‘self-serving publicity campaign.’
WASHINGTON — The Assn. of Trial Lawyers of America and several physicians Tuesday warned of potential dangers associated with a widely prescribed asthma drug, although the drug’s manufacturer called the warning a “self-serving publicity campaign.”
Michael Maher, president of the lawyers’ group, emphasized that the drug can be “a vital contributor to the health and comfort of a person suffering from severe chronic asthma,” but it can also “present considerable risks.”
“Theophylline can be a life-saver or a life-taker--and an unsuspecting public often doesn’t understand the real risks,” he said.
Nearly 10 million Americans suffer from asthma and its incidence and death rate are both increasing, experts said.
Schering-Plough Corp. of Madison, N.J., one of more than 30 companies that make the drug, said it felt compelled to alert the public to “self-serving publicity campaigns by the organized plaintiffs’ trial bar.”
The company defended the drug, calling it an “important, well-established treatment.” It added that “properly used, under physician supervision and in accordance with approved labeling, serious theophylline side effects have been very rare.”
More than 60 million prescriptions have been written in the last five years and adverse reactions totaled 1.3 per 100,000, a company spokesman said.
The drug is a so-called “narrow therapeutic range” drug, meaning that the dosage must be carefully controlled. Too small an amount can be ineffective, while even a slightly larger amount can be dangerous.
Asthma experts called on by both the company and the lawyers’ group said that it is extremely important that physicians monitor blood levels of the drug to be sure their patients are not receiving toxic dosages. Metabolism of the drug varies widely among patients.
“It is one of the most difficult medicines to manage,” said Dr. Howard J. Zeitz, director of the Max Sampter Institute of Allergy and Clinical Immunology at Grant Hospital in Chicago, who was asked by the lawyers’ group to talk about the drug.
“Even small changes in dosage can lead to wide changes in patients,” said Zeitz, who added that numerous deaths occur each year “from direct theophylline toxicity.”
“We don’t know the true numbers, but they appear to be less than 100 and more than 20” annually, Zeitz said.
Food and Drug Administration spokesman Jeff Nesbit said that the drug has been in use for 40 years and “these side effects ought to be well-known to the medical community.” He said that non-prescription sales of the drug alone were banned in 1986. The agency has proposed banning the drug in combination form but is still reviewing evidence.
The drug is found in such non-prescription products as Primatene Tablets M Formula, Bronkaid tablets, Bronkolixer and Bronkotabs, the lawyers’ group said. It can also be found in Primatene Tablets P Formula in those states that do not require a prescription for this medication.
The Food and Drug Administration said that the amounts of theophylline in over-the-counter medications are very small and the agency is not aware of any deaths associated with them.
But the lawyers’ group urged that the drug no longer be available without a prescription and called for stronger safeguards for those who must use it by prescription.
Dr. Allan Weinstein, assistant professor of medicine at Georgetown University Hospital and a consultant to the National Institute of Allergy and Infectious Diseases, said that the product “is very safe when used in experienced hands.” Weinstein was asked by Schering-Plough to talk about the drug.
The lawyers’ group has asked the FDA to require package inserts for patients, advising them of the dangers, and increased physician education.
