Drug discovery 40-43.indd

Drug withdra
Drug withdr w
als and bans
Discovery, development and introduction of
a new drug takes approximately 12 years of
intelligent hard work, tremendous patience, and
incurs an expenditure of about $ one billion.
Sadly, after having done so much for a new drug,
which is expected to be a blockbuster and a
significant advancement in therapeutics, many
a times, either a ban is imposed on its sale by
the regulatory authority or the manufacturer
voluntarily withdraws it from the market. From
the long list of drug bans and withdrawals,
this article describes the lessons learnt
from the first drug withdrawal, thalidomide, and the
resurrection of the drug. It briefly describes about
a few new prototype drug withdrawals followed
by lessons learnt; also of lessons learnt from the
withdrawals of rofecoxib and valdecoxib.
company, Grünenthal. In fact, this drug was sold between 1957 and 1961 in during the 33-year period almost 50 countries under at least particularly phocomelia in children born 10,000 children were born with severe congenital malformations including Thalidomide: The story
described as ‘Thalidomide Tragedy’ and has been attributed to the release of the pre-clinical safety studies. Subsequently, laws in 1962, requiring tests for safety Drugs withdrawn worldwide, 1950s onwards, and reason for withdrawal
Thalidomide: Lessons
Reason for withdrawal
withdrawal
Teratogenicity, returned to market for use 1950s-1960s in ENL-reaction in leprosy and multiple 1950s-1960s Abuse for recreational purpose development of new clinical applications and resurrection Risk of psychiatric adverse drug reactions leprosy patients. The drug was approved by the US Food and Risk of fatal complications of constipation (reintroduced in 2002 on restricted basis) Drug Administration (USFDA) in July 1998 for use in ENL under the Mandrax. It has also been used illegally as a recreational drug, particularly in the Behçet’s disease and Crohn’s disease. was a ‘safer’ drug than barbiturates to In a small trial, Australian researchers Drug withdrawals in the US
reuptake inhibitor (SSRI) antidepressant. fatal, cases of central and/or peripheral (Omniflox); antihistamines - terfenadine antidepressants - nomifensine (Merital); antihypertensive - mibefradil (Posicor), - troglitazone (Rezulin), and cholesterol lowering agent - cerivastatin (Baycol).
Drug withdrawal cases
including strange and violent behaviour, market, after reports in the US indicated cent confidence interval 1.72 to 14.29), because of doubling of the risk of major cardiovascular events (relative risk, 1.92; 5-10 times that of the other statins.
Rofecoxib: Lessons learnt
constituted a part of screening process. registration clinical trials. Therefore, in loopholes were left. Also, devise suitable analysis of pre-clinical and clinical data in inflammation, pain and fever. Thus, a Some suggestions
devoid of gastrointestinal adverse effects. pharmaceutical companies and possesses an Y Pre-clinical data should be critically extensive experience of more than 27 years in clinical research, regulatory affairs, and industry. He is also engaged in providing clinical research and medico-marketing to

Source: http://www.aceas.co.in/pdf/12Dr_AK_Batham_Mar_2009.pdf