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Pharmacology experts specializing in regulatory methodologies to analyze drug adverse events

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In addition to giving a therapeutic benefit, drugs may cause secondary effects. Most adverse events are mild and disappear with the discontinuation of the drug, but other side effects can be severe, long lasting or even permanent.  An analysis of the FDA’s adverse event database can help find if the adverse event is rare or prevalent and if a potential FDA labeling change is needed.

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The variance in the genetic code of the American population can cause specific individuals to be hypersensitive to the pharmacologic properties of a drug.  An individual may exhibit an exaggerated therapeutic response or adverse even from a drug, even when the drug is given at a typical dose that has ben found safe in others.

Hypersensitivity may be due to an altered pharmacokinetic response which leads to higher-than-usual concentration levels in the blood. Genetic variances may also lead to increased receptor sensitivity, increasing an individual’s response to therapeutic or adverse effects.

The incidence of adverse effects vary by patient characteristics (including: age, sex, ethnicity, coexisting disorders, genetic or geographic factors) and by drug factors including: type of drug, administration route, treatment duration, dosage, bioavailability). Most adverse effects are dose-related but can also be allergic or idiosyncratic.

Allergic adverse effects are not related to the drug’s dose and require prior exposure to the drug. Allergic reactions develop when a drug acts as an antigen or allergen.

After a patient is sensitized, subsequent exposure to the drug produces one of several different types of allergic reaction. Drug history and screening with skin tests can sometimes help predict allergic adverse effects.

Idiosyncrasy is used to describe adverse effects that are not dose-related or allergic reactions. They occur in a small percentage of patients.

Idiosyncrasy has been defined as a genetically determined abnormal response to a drug, but not all idiosyncratic reactions have a genetic cause. The exact mechanism of an idiosyncratic adverse is not unknown.

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