Pharmacoepidemiology is the study of drug use and the effects of drugs in a large number of randomly non-selected people. Pharmacoepidemiology is a relatively new applied field, linking clinical pharmacology and epidemiology. Pharmacoepidemiological studies are post-marketing studies which traditionally:

1. Pharmacoepidemiological Study for
Drug Withdrawn from the
European Market between
2005 –10 for Safety Reasons
By Piyush Tripathi
piyushtripathi1992@rediffmail.co
m

2. DRUG WITHDRAWAL &
PHARMACOEPIDEMIOLOGICAL
STUDIES
Because of unexpected adverse effects
Pharmacoepidemiology is the study of drug use
and the effects of drugs in a large number of
randomly non-selected people
Pharmacoepidemiological studies are essential for
the study of certain adverse events such as
psychomotor impairment, intoxications and drug
abuse.

3. S. No. Drug Name Year first
marketed
Year of
withdrawal
Length of time on
market (years)
Adverse
Reactions
1 Thioridazine 1958 2005 47 Cardiac
Disorders
2 Valdecoxib 2003 2005 2 Cardiovascular
Disorders
3 Rosiglitazone 2000 2010 10 Cardiovascular
Disorders
4 Sibutramine 1999 2010 11 Cardiovascular
Disorders
5 Orciprenaline 1961 2010 49 Cardiac
Disorders
DRUGS HAVE BEEN WITHDRAWN
FROM THE MARKET

4. DRUGS with ADR
• Thioridazine (antipsychotics) –
Schizophrenia - Cardiac Arrhythmias and
Sudden Death
• Valdecoxib (NSAIDs) – Inflammation
caused by Osteoarthritis - Life-threatening
Skin Reactions
• Rosiglitazone (thiazolidinediones) – Type-2
Diabetes - Heart Attack and Stroke

5. • Sibutramine (appetite suppressants) –
Weight Loss - Stroke and Myocardial
Infarction
• Orciprenaline (bronchodilator) - Bronchial
Asthma - Cardiac Side Effects mainly
Palpitations and Tachycardia

6. REFERENCES
1. B., Storm. Pharmacoepidemiology. s.I. : Chichester: John
Wiley & Sons, 2000.
2. Thioridazine. National Library of Medicine. [Online] 16 05
2011. [Cited: 10 10 2015.]
https://www.nlm.nih.gov/medlineplus/druginfo/meds/a682119.
html.
3. News & Updates. Essential Medicines and Health Products
Information Portal. [Online] 25 01 2005. [Cited: 10 10 2015.]
http://apps.who.int/medicinedocs/en/d/Js8116e/1.7.html.
4. Bextra Withdrawn From Market. Medscape. [Online] 07 04
2005. [Cited: 10 10 2015.]
http://www.medscape.com/viewarticle/502642.