The article on warnings and precautions intends to identify and describe a discrete subset of adverse drug reactions and other potential safety hazards that are serious or are otherwise clinically significant because they have implications for prescribing decisions or for patient management from the past six months, however, is not a complete list. Some factors to consider in assessing whether there is reasonable evidence of a causal relationship include: The frequency of reporting Whether the adverse event rate in the drug treatment group exceed the rate in placebo and active-control group in controlled trials Evidence of a dose-dependent relationship The extent to which the adverse event is consistent with the pharmacology of the drug The temporal association between drug administration and the event Existence of dechallenge and rechallenge experience Whether the adverse drug event is…