FIRST SAI SIDDHA GET TOGETHER

DATE:05-aug-12

SAFETY SIDDHA DRUG PROFILE

Dr.S.SENTHILNATHAN,

THE CHILDS TRUST MEDICAL FOUNDATION, KKKCTH,

CHENNAI.

ADVERSE EVENT/ADVERSE DRUG REACTIONAny 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.

SERIOUS ADVERSE EVENTA 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.

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 .

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

DRUG WITHDRAWN FROM MARKET • Nimesulide, cisapride and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.

REPORTING AE AE form

Adverse Event

NON SERIOUS SERIOUSRecord in CRF

Record in CRF

Report EXPEDITEDLY

ETHICS COMMITTEE

SPONSOR DSMB

REGULATORY AUTHORITY DCGI

14 Calendar days

24 Hours

7 Calendar days

IMPLEMENTING AE REPORTING IN SIDDHA

MEDICINE