Vannair Adverse Reactions

Since Vannair pMDI contains both budesonide and formoterol, the same adverse effects as reported for these substances may be expected. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common drug related adverse reactions are pharmacologically predictable side-effects of β₂-agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of commencing treatment.
In the clinical program comparing Vannair pMDI with Symbicort Turbuhaler, 679 adults and adolescents (Study 681 and Study 715) were exposed to Vannair pMDI 640/18 μg daily with a median duration of 359 days and a range of 1 to 427 days.
There were no apparent differences in the overall pattern of AE's between the Vannair pMDI and Symbicort Turbuhaler groups in the clinical program. The AEs were generally mild to moderate in intensity and the pattern was that usually seen in a population with persistent asthma and dominated by symptoms of upper respiratory events.
Overall, the AE profile was similar for patients receiving Vannair pMDI and Symbicort Turbuhaler with regard to total daily dose, age, sex, and ethnic group and no new safety concerns were identified with Vannair pMDI.
If oropharyngeal candidiasis develops, it may be treated with appropriate anti‑fungal therapy whilst still continuing with Vannair therapy. The incidence of candidiasis can generally be held to a minimum by having patients rinse their mouth out with water after inhaling their maintenance dose.
Adverse reactions, which have been associated with budesonide, formoterol, and Vannair, are given as follows. (See Table 4.)

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As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases.
Treatment with β-sympathomimetics may result in an increase in blood levels of insulin, free fatty acids, glycerol, and ketone bodies.
Pneumonia: The following table provides the incidence of pneumonia observed in the four pivotal phase III COPD studies (see Pharmacology: Pharmacodynamics: Clinical trials: COPD under Actions) for the Symbicort Turbuhaler or Vannair pMDI 160/4.5 and comparative placebo arms. (See Table 5.)

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In these placebo-controlled studies, the incidence of pneumonia was low, with no consistent evidence of increased risk of pneumonia for Symbicort/Vannair-treated patients compared to patients on placebo.
Reporting suspected adverse effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are recommended to report any suspected adverse reactions to AstraZeneca.