Serious adverse events formulation

In another patient, serious adverse events (fever, severe rigors, a fall in blood pressure, worsening mental status, increasing creatinine concentration, and leukocjdosis) occurred after unrecognized substitution of one amphotericin formulation (ABLC) by another (ABCD) (132). After discovery of the switch, ABLC therapy was rein-stituted and tolerated without incident. 

A modified-release formulation of salbutamol (ProventU Repitabs) 12 mg bd was well tolerated in children. There were no serious adverse events and no changes in vital signs or the electrocardiogram (SEDA-21,182). 

Drug formulations In a single-dose, open, randomized, two-way, crossover study in 28 fasted healthy adults a capsule formulation of tizanidine hydrochloride was compared with the capsule contents administered in applesauce they were not bioequivalent [80 ]. The drug was more available (90% Cl = 103-134%) when the contents were sprinkled on to apple sauce. A total of 31 adverse events were reported by 17 of the 28 subjects 15 who took the intact capsule reported 18 events and 11 who took the contents reported 13 events. There were no serious adverse events. 

Propylene glycol is used as solvents in many formulations (e.g., oral, topical, and parenteral routes) for poorly soluble compounds such as phenobarbital, phenytoin, diazepam, and multivitamin concentrates. Because of the limited metabolic pathways in children younger than four years, number of adverse events has been described (laxative effects per os, contact dermatitis) but mainly serious systemic CNS depression. Seven of... 

Intravenous formulations are probably the least demanding of all injectates. Solutions of thiopental sodium are routinely administered at the induction of anesthesia, but are extremely alkaline and would be very damaging if administered subcutaneously or intramuscularly. Unfortunately, this occurs occasionally as an iatrogenic adverse event when the injection (pH 9) extravasates serious injury can easily occur to the structures in the cubital fossa (including the median nerve). 

Drag formulations Patients with Paget s disease of bone who use daily oral bisphosphonates can have serious upper gastrointestinal adverse events, and a... 

Complaints of adverse reactions to clinical supplies are typically seen as reportable events that impact the safety or efficacy of the test article. Companies should give consideration to the possibility that an increase in the frequency or severity of adverse reactions may be linked to a manufacturing defect. For example, a product that has been formulated such that it is super-potent in its final form can be expected to produce adverse reactions of greater severity or frequency than if it was properly formulated. Labeling mix-ups can have devastating impact on patients, or, at minimum, may seriously affect the validity of a clinical trial. Therefore, the following elements should be included in the complaint assessment system ... 

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