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R A Nicklas

Publications and source records attributed to R A Nicklas.

16 recordsLinked to original sources
PubMed1990

Paradoxical bronchospasm associated with the use of inhaled beta agonists.

Adverse reaction reports for inhaled relatively beta 2-selective, adrenergic-agonist bronchodilators submitted to the Center for Drug Evaluation and Research of the Food and Drug Administration between 1974 and 1988 were reviewed. There were 126 reports associated with the use of these drugs by metered-dose inhaler, which were consistent with a diagnosis of paradoxical bronchospasm. In addition, 58 such reports were received for these drugs delivered as a solution for nebulization between 1983 and 1988. Increased reporting of reactions consistent with paradoxical bronchospasm generally correlated with increased availability of these products during the same time period, although there has not been a steady upward trend in such reports for metered-dose inhalers during the past 3 years, despite increasing distribution figures. Despite the apparent infrequency of inhaler-induced paradoxical bronchospasm, the potentially life-threatening nature of such reactions makes awareness of this possibility essential. Patients who report that an inhaled beta-adrenergic agonist makes their asthma worse, as well as the patients who fail to demonstrate expected improvement with this form of therapy, should be suspected of having developed paradoxical bronchospasm.

Adrenergic beta-Agonists↗
PubMed1989

Perspective on asthma mortality--1989.

Morbidity and mortality from asthma have been increasing in the United States and other countries. Although the reason for these changes is unknown, there are a number of possibilities. Authoritative reviews of epidemics of asthma deaths in other countries have focused on patient management, particularly the failure of patients and physicians to recognize the severity of the patients' asthma. Of great concern, however, has been the possibility that increases in asthma mortality reflect changes in the way that physicians treat asthma; most notably the use of multiple drug regimens (sometimes inappropriately) and dependence on inhaled beta agonists. Since most asthmatic patients are effectively and safely managed with present therapeutic modalities, it is essential that features that distinguish the fatality-prone asthmatic be characterized as distinctly as possible. It is reasonable to conclude that such a patient may be the patient whose asthma is not well defined, sometimes in terms of the diagnosis but more often in terms of the severity of their condition. This may be associated with a failure to utilize pulmonary function tests, and result in lack of an appropriate plan of action for exacerbations of asthma through cooperative management. As a result, there may be underutilization of corticosteroids, which are necessary for the treatment of inflammation associated with chronic asthma. Misunderstanding about the need to avoid external triggers and treat internal precipitants as well as inability to recognize the potential for medication-induced adverse effects may further characterize the fatality-prone asthmatic. Further studies are needed to confirm or to refute the speculative association between current management of asthmatic patients and morbidity and mortality.(ABSTRACT TRUNCATED AT 250 WORDS)

Asthma↗
PubMed1989

The investigative process for new drugs.

In summary, there are preclinical and clinical developmental periods during the study of new drugs. The latter is composed of three phases of study under an IND. The purpose of phase I is to show the initial safety of the drug. Efficacy should be demonstrated in phase II. Long-term studies in a large number of patients in phase III are designed to demonstrate the long-term safety and continued efficacy of the drug. Following review and acceptance that the data generated during these two developmental periods and submitted by the sponsor under an NDA demonstrate the safety and efficacy of the drug, the drug may be approved for marketing. If so, there will be continued evaluation of the drug during postmarketing surveillance. The phases of study that are required to demonstrate that a new drug is safe and efficacious are straightforward and clearly defined. The methods that are best used to satisfy these requirements are less clear and more open to interpretation by both sponsors and Agency reviewers. Guidelines for the testing of new drugs are extremely helpful in this regard, but will never (and probably never should) take the place of enlightened individual judgment on the part of investigators, sponsors, and FDA reviewers.

Drug Evaluation↗
PubMed1986

Adverse effects of theophylline-beta agonist interactions.

Beta-adrenergic agonists, when administered alone or concomitantly with methylxanthines are capable of producing lesions of myocardial necrosis and an increased incidence of cardiac arrhythmias in several species of animals. These drugs, including "beta 2-specific" agonists, also have the potential to produce adverse cardiovascular effects when used clinically. In addition, beta agonists and methylxanthines can interact to potentiate or lessen effectiveness and theoretically increase the risk to the patient. As a result, the extent to which the concomitant administration of these drugs may contribute to adverse clinical effects needs further clarification.

Adrenergic beta-Agonists↗
PubMed1985

Sulfite sensitivity in a seven-year-old child.

Recognition of sulfite sensitivity by the practicing physician has become increasingly important. A wide spectrum of reactions can occur after the ingestion or inhalation of sulfites in foods and medications. This case report of a 7-year-old child with sulfite sensitivity expands the patient population at risk even further.

Child↗
PubMedDate not supplied

Sulfites: a review with emphasis on biochemistry and clinical application.

Despite the increasing amount of data that has accumulated on sulfites as the intensity of medical interest has expanded in recent years, there are lingering, difficult, and, in most cases, as yet unresolved questions about sulfite sensitivity. These include questions about mechanism of action, prevalence, the most effective methods for protecting sulfite-sensitive patients from exposure to sulfites, and other issues. Perhaps the most important question, however, is whether sulfite sensitivity represents but one example of reactions that have occurred, are occurring, or will occur from exposure to additives and chemicals in the environment.

Anaphylaxis↗