SAFETY SIDDHA DRUGPROFILE Dr.S.SENTHILNATHAN, THE CHILDS TRUST MEDICAL FOUNDATION, KKKCTH, CHENNAI.
ADVERSE EVENT/ADVERSEDRUG 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DRUG WITHDRAWN FROMMARKET• Nimesulide, cisapride and phenylpropanolamine were found serious side effects since early 2000 and many developed countries had already banned all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.