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According to FDA prescribing information concerning the observed side effects of AVA (BioThrax), local adverse reactions have been observed (especially at injection site), for example, tenderness, pain, erythema, edema, and arm motion limitation; (≥5%) as well as systemic adverse reactions: fatigue headache and muscle aches [ 99].
The observed side effects were dizziness, drowsiness and increase in appetite.
We wanted to assess the risk factors for overdosing in ICU and the related observed side effects.
Considering the observed side effects, doses should be accurately monitored and reduced, particularly when renal replacement therapy is needed.
Finally, before 2012, the reason for assessing oxa- or cloxacillin concentration was not mentioned; we could suppose clinicians suspected an overdosing because of observed side effects.
Considering the high frequency of observed side effects, doses should be accurately monitored and reduced, particularly when renal replacement therapy is needed.
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With this high dose, death was not observed in ICR mice, but mild diarrhea was the only observed side effect.
Thrombocytopenia, which is a constantly observed side effect of these drugs, is limiting dose escalade and drug combinations.
Compliance was monitored by determining quercetin plasma concentrations after the treatment periods (see below), by counting capsules at the end of the study and by instructing subjects to document capsule consumption, potential observed side-effects, deviations from their normal physical activity and any other observations considered relevant in a study diary.
There also were no observed side-effects indicative of thiazolidinedione treatment, such as edema, increased adipocyte proliferation and increased body weight (data not shown).
We eventually analysed the pharmacokinetic of free and liposomal DXM-P to correlate the presence of drug with the observed side-effects.
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