ADVERSE DRUG REACTIONS GENDER AS A RISK FACTOR

Chief Editor
DR T R RAMANUJAM M.D., C.MI.Biol (Lond)

WHAT IS ADVERSE DRUG REACTION

GENDER EFFECTS OF PHARMACOLOGY

WHAT IS ADVERSE DRUG REACTION

ANY  NOXIOUS, UNINTENDED & UNDESIRED EFFECT OF A DRUG WHICH OCCURS AT A DOSE  USED  IN HUMANS FOR    PROPHYLACTIC,   DIAGNOSTIC  OR  THERAPEUTIC   PURPOSES.

FDA Definition- Any adverse event associated with the use of drugs in humans whether or not considered drug related including the following:

 · an adverse event occurring in the course of  the use of drug in professional practice,
 · an adverse event  from drug overdose whether accidental or intentional,
 · an adverse event  occurring from drug abuse,
 · an adverse event  from drug withdrawal,
 · any significant failure of expected pharmacological action.

Probability

• Definitive
• Probable
• Possible
• Doubtful

Determination based on the presence of conclusive reports in literature, a negative dechallenge, positive rechallenge, alternate causes, a positive dose response relationship, a temporal relationship, and presence of toxic drug concentration.

-Mild - symptomatic treatment, alter dose, no change of drug
- Moderate - change in drug therapy
- Severe - unexpected untoward leading to possible debility, or death.