3. ADVERSE EVENT/ADVERSE
DRUG REACTION
Any untoward medical occurrence (including a
symptom / disease or an abnormal laboratory
finding) during treatment with a
pharmaceutical product in a patient or a
human volunteer that does not necessarily
have a relationship with the treatment being
given.
4. SERIOUS ADVERSE EVENT
A serious adverse event (experience) or reaction is
any untoward medical occurrence that at any dose:
Results in death,
Is life-threatening,
(NOTE: The term "life-threatening" in the definition of "serious"
refers to an event in which the patient was at risk of death at
the time of the event; it does not refer to an event which
hypothetically might have caused death if it were more
severe.)
Requires Inpatient Hospitalization or prolongation of existing
Hospitalization,
Results in persistent or significant Disability / Incapacity, or
Is a Congenital Anomaly / Birth defect.
5. SIGNIFICANCE OF AE
• Rofecoxib (NSAID)was approved as safe and
effective by the Food and Drug Administration
(FDA) on May 20, 1999 and was subsequently
marketed under the brand name Vioxx, Ceoxx and
Ceeoxx.
• In April 2002, warnings on Vioxx labelling
concerning the increased risk of cardiovascular
events (Heart attack and Stroke) associated with
long-term, high-dosage use were issued .
6. Cont…
A blockbuster drug that had been marketed in
more than 80 countries with worldwide sales
totaling $2.5 billion in 2003.
On September 30, 2004, Merck voluntarily
withdrew Rofecoxib from the market because
of concerns about increased risk of Myocardial
Infarction and Stroke
7. DRUG WITHDRAWN FROM
MARKET
• Nimesulide, cisapride and
phenylpropanolamine were found serious side
effects since early 2000 and many developed
countries had already banned all of them.
• DCGI waked up little late and ordered
examining safety profile.
• Banned Drugs.
9. Adverse Event
Record in NON SERIOUS SERIOUS
CRF
Record in CRF
7 Calendar days
Report
ETHICS
EXPEDITEDLY
COMMITTE
E
24 Hours
SPONSOR DSMB
14 Calendar days
REGULATORY
AUTHORITY
DCGI
