Bioequivalence and Bioavailability Forum

Hi Rajdoc,

❝ My question is. Is drowsiness an unintended effect of anti psychotics????....

❝ Could we really term the side effect as an adverse effect

Perseverated. You have to report all AEs, expected or not, drug-related or not. Once in our studies a volunteer was bitten by a dog in the washout period. Since he had to visit the next ambulance to get some stitches, it was even an SAE. Drug-related? No way. Reported? Sure.

I don’t understand why you are trying to navigate around reporting AEs, especially if they are clearly TEAEs like in your case.

❝ FDA itself states that the participant has to be in supine position for certain period for antipsychotics, we cannot expect the participant to be awake and alert in that position...

Are you trying to tell that subjects are drowsy not caused by the drug but by the fact that they are lying in bed?

• Sometimes I watch TV in bed and I can assure you that I’m both awake and alert.
  
• Sometimes in the office (in upright position) while reading posts in the forum only a quick shot of coffee can prevent me from falling into a deep slumber.