From thalidomide to rofecoxib: Can we afford to wait and watch?

S.A. Khan, P.G.M. Rao, G.S. Rodrigues, S. Rajan, A. Heda

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Drug safety constitutes the cornerstone of modern therapeutics. Nowadays, the focus tends to be more on the hazards of drugs rather than on their benefits. This article describes from a healthcare professional's viewpoint the history behind two major drug disasters: thalidomide and rofecoxib and the reasons why drug withdrawals continue, taking the classic example of rofecoxib despite our safety concerns and the method to overcome those disasters in the future. The paper highlights the major steps to be followed for pharmacovigilance as an effective component of drug safety. The responsibility of healthcare professionals has ultimately to do with patient care and is to promote a culture of safe and efficacious drug use and thereby preventing future disasters related to modern therapeutics. © 2006 - IOS Press and the authors. All rights reserved.
Original languageEnglish
Pages (from-to)219-230
Number of pages12
JournalInternational Journal of Risk and Safety in Medicine
Volume18
Issue number4
Publication statusPublished - 2006

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Thalidomide
Disasters
Pharmaceutical Preparations
Safety
Delivery of Health Care
Pharmacovigilance
rofecoxib
Patient Care
History
Therapeutics

Cite this

Khan, S.A. ; Rao, P.G.M. ; Rodrigues, G.S. ; Rajan, S. ; Heda, A. / From thalidomide to rofecoxib: Can we afford to wait and watch?. In: International Journal of Risk and Safety in Medicine. 2006 ; Vol. 18, No. 4. pp. 219-230.
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title = "From thalidomide to rofecoxib: Can we afford to wait and watch?",
abstract = "Drug safety constitutes the cornerstone of modern therapeutics. Nowadays, the focus tends to be more on the hazards of drugs rather than on their benefits. This article describes from a healthcare professional's viewpoint the history behind two major drug disasters: thalidomide and rofecoxib and the reasons why drug withdrawals continue, taking the classic example of rofecoxib despite our safety concerns and the method to overcome those disasters in the future. The paper highlights the major steps to be followed for pharmacovigilance as an effective component of drug safety. The responsibility of healthcare professionals has ultimately to do with patient care and is to promote a culture of safe and efficacious drug use and thereby preventing future disasters related to modern therapeutics. {\circledC} 2006 - IOS Press and the authors. All rights reserved.",
author = "S.A. Khan and P.G.M. Rao and G.S. Rodrigues and S. Rajan and A. Heda",
note = "Cited By :7 Export Date: 10 November 2017 CODEN: IJMDE Correspondence Address: Khan, S.A.; Department of Pharmacy Practice, S S Cancer Hospital, Research Centre, Manipal 576 104, Karnataka State, India; email: sohailkhan1981@gmail.com Chemicals/CAS: althesin, 8067-82-1; benoxaprofen, 51234-28-7; celecoxib, 169590-42-5; centoxin, 138330-99-1; diclofenac, 15307-79-6, 15307-86-5; dilevalol, 75659-07-3; fenclofenac, 34645-84-6; feprazone, 30748-29-9; ibuprofen, 15687-27-1; indometacin, 53-86-1, 74252-25-8, 7681-54-1; indoprofen, 31842-01-0; metipranolol, 22664-55-7; naproxen, 22204-53-1, 26159-34-2; nomifensine maleate, 32795-47-4; pemoline, 2152-34-3; perhexiline maleate, 6724-53-4; practolol, 6673-35-4; remoxipride, 78810-02-3, 80125-14-0, 82935-42-0; rofecoxib, 162011-90-7, 186912-82-3; sertindole, 106516-24-9; suprofen, 40828-46-4; temafloxacin, 105784-61-0, 108319-06-8; terodiline, 15793-40-5, 7082-21-5; thalidomide, 50-35-1; tolcapone, 134308-13-7; triazolam, 28911-01-5; zimeldine, 56775-88-3, 60525-15-7; zomepirac, 33369-31-2, 64092-48-4 Tradenames: althesin; centoxin; eraldin; flenac; flosint; glauline; halcion; merital; methrazone; micturin; opren; osmosin; pexid; roxiam; serdolect; suprol; tasmar; teflox; unicard; vioxx; volital; zelmid; zomepirac Manufacturers: Pfizer References: Andersohn, F., Suissa, S., Garbe, E., Use of first- And second-generation cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs and risk of acute myocardial infarction (2006) Circulation, , Apr. 17; [Epub ahead of print]; Bakr, M., Waller, D.G., COX-2 Inhibitors and the cardiovascular system: Is there a class effect? (2005) Br. J. Cardiol., 12, pp. 387-391; Bombardier, C., Laine, L., Reicin, A., Shapiro, D., Burgos-Vargas, R., Davis, B., Day, R., Schnitzer, T.J., Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis (2000) N. Engl. J. Med., 343, pp. 1520-1528. , VIGOR study group; Van Boxtel, C.J., Lessons still to be learned from Thalidomide (2004) Int. J. Risk & Safety Med., 16, pp. 103-106; Carn{\'e}, X., Cruz, N., Ten lessons to be learned from the withdrawal of Vioxx R{\circledR} (rofecoxib) (2005) European Journal of Epidemiology, 20, pp. 127-129; Classen, D.C., Pestotnik, S.L., Evans, S., Loyd, J.F., Burke, J.P., Adverse drug events in hospitalized patients (1997) JAMA, 227, pp. 301-306; Collins, T.F., History and evolution of reproductive and developmental toxicology guidelines (2006) Curr. Pharm. Des., 12, pp. 1449-1465; Curran, W.J., The thalidomide tragedy in Germany: The end of a historic medicolegal trial (1971) N. Engl. J. Med., 284, pp. 481-482; Curtis, S., Mukhopadhyay, S., Ramey, D., Reicin, A.S., Etoricoxib cardiovascular safety summary (2003) Circulation, 108, pp. 378-379; Dogne, J.M., Hanson, J., Supuran, C., Pratico, D., Coxibs and cardiovascular side-effects: From light to shadow (2006) Curr. Pharm. Des., 12, pp. 971-975; Farkouh, M.E., Kirshner, H., Harrington, R.A., Ruland, S., Verheugt, F.W., Schnitzer, T., Burmester, G.R., Chesebro, J.H., Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: Randomized controlled trial (2004) Lancet, 364, pp. 675-684; Graham, D.J., Campen, D., Hui, R., Spence, M., Cheetham, C., Levy, G., Shoor, S., Ray, W.A., Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: Nested case-control study (2005) Lancet, 365, pp. 475-481; Hawkey, C.J., COX-2 inhibitors (1999) Lancet, 353, pp. 307-314; Jack, D., Pre-20th century evidence for the placental passage of drugs (2005) Drug News Perspect., 18, pp. 222-224; Juni, P., Nartey, L., Reichenbach, S., Sterchi, R., Dieppe, P.A., Egger, M., Risk of cardiovascular events and rofecoxib: Cumulative meta-analysis (2004) Lancet, 364, pp. 2021-2029; Latest Pharmaceutical News, , http://www.drugs.com/news.html, Accessed at on 28th May 2006; Mann, R.D., Andrews, E.B., Introduction (2002) Pharmacovigilance, pp. 3-5. , R. Mann and E. Andrews, eds, Wiley, London; Maxwell, S.R.J., Webb, D.J., COX-2 selective inhibitors-important lessons learned (2005) Lancet, 365, pp. 449-451; Ostor, A.J., Hazleman, B.L., The murky waters of the coxibs: A review of the current state of play (2005) Inflammopharmacology, 13, pp. 371-380; Rawlins, M.D., Predicting the future from lessons of the past (1997) Int. J. Pharm. Med, 1, pp. 37-40; Rawlins, M.D., Jefferys, D.B., Study of United Kingdom product licence applications containing new active substances (1987) BMJ, 302, pp. 223-225; Silverstein, F.E., Faich, G., Goldstein, J.L., Simon, L.S., Pincus, T., Whelton, A., Makuch, R., Geis, G.S., Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis. the CLASS study: A randomized controlled study (2000) JAMA, 284, pp. 1247-1255; Sooriakumaran, P., COX-2 inhibitors and the heart: Are all coxibs the same? (2006) Postgrad. Med. J., 82, pp. 242-245; http://www.fda.gov/cder/drug/infopage/default.htm, Accessed at on 27th May 2006; Waller, P.C., Making the most of spontaneous adverse drug reaction reporting (2006) Basic Clin. Pharmacol. Toxicol., 98, pp. 320-323; Waller, P.C., Tilson, H.H., Managing drug safety issues with marketed products (2004) Stephen's Detection of New Adverse Drug Reactions, pp. 345-374. , J. Talbot and P. Waller, eds, Wiley, London; Wolfe, M.M., Lichtenstein, D.R., Singh, G., Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs (1999) N. Engl. J. Med., 340, pp. 1888-1899; Wong, Y.L., Adverse effect of pharmaceutical recipients in drug therapy (1993) Ann. Acad. Med., 22, pp. 99-102",
year = "2006",
language = "English",
volume = "18",
pages = "219--230",
journal = "International Journal of Risk and Safety in Medicine",
issn = "0924-6479",
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}

From thalidomide to rofecoxib: Can we afford to wait and watch? / Khan, S.A.; Rao, P.G.M.; Rodrigues, G.S.; Rajan, S.; Heda, A.

In: International Journal of Risk and Safety in Medicine, Vol. 18, No. 4, 2006, p. 219-230.

Research output: Contribution to journalArticle

TY - JOUR

T1 - From thalidomide to rofecoxib: Can we afford to wait and watch?

AU - Khan, S.A.

AU - Rao, P.G.M.

AU - Rodrigues, G.S.

AU - Rajan, S.

AU - Heda, A.

N1 - Cited By :7 Export Date: 10 November 2017 CODEN: IJMDE Correspondence Address: Khan, S.A.; Department of Pharmacy Practice, S S Cancer Hospital, Research Centre, Manipal 576 104, Karnataka State, India; email: sohailkhan1981@gmail.com Chemicals/CAS: althesin, 8067-82-1; benoxaprofen, 51234-28-7; celecoxib, 169590-42-5; centoxin, 138330-99-1; diclofenac, 15307-79-6, 15307-86-5; dilevalol, 75659-07-3; fenclofenac, 34645-84-6; feprazone, 30748-29-9; ibuprofen, 15687-27-1; indometacin, 53-86-1, 74252-25-8, 7681-54-1; indoprofen, 31842-01-0; metipranolol, 22664-55-7; naproxen, 22204-53-1, 26159-34-2; nomifensine maleate, 32795-47-4; pemoline, 2152-34-3; perhexiline maleate, 6724-53-4; practolol, 6673-35-4; remoxipride, 78810-02-3, 80125-14-0, 82935-42-0; rofecoxib, 162011-90-7, 186912-82-3; sertindole, 106516-24-9; suprofen, 40828-46-4; temafloxacin, 105784-61-0, 108319-06-8; terodiline, 15793-40-5, 7082-21-5; thalidomide, 50-35-1; tolcapone, 134308-13-7; triazolam, 28911-01-5; zimeldine, 56775-88-3, 60525-15-7; zomepirac, 33369-31-2, 64092-48-4 Tradenames: althesin; centoxin; eraldin; flenac; flosint; glauline; halcion; merital; methrazone; micturin; opren; osmosin; pexid; roxiam; serdolect; suprol; tasmar; teflox; unicard; vioxx; volital; zelmid; zomepirac Manufacturers: Pfizer References: Andersohn, F., Suissa, S., Garbe, E., Use of first- And second-generation cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs and risk of acute myocardial infarction (2006) Circulation, , Apr. 17; [Epub ahead of print]; Bakr, M., Waller, D.G., COX-2 Inhibitors and the cardiovascular system: Is there a class effect? (2005) Br. J. Cardiol., 12, pp. 387-391; Bombardier, C., Laine, L., Reicin, A., Shapiro, D., Burgos-Vargas, R., Davis, B., Day, R., Schnitzer, T.J., Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis (2000) N. Engl. J. Med., 343, pp. 1520-1528. , VIGOR study group; Van Boxtel, C.J., Lessons still to be learned from Thalidomide (2004) Int. J. Risk & Safety Med., 16, pp. 103-106; Carné, X., Cruz, N., Ten lessons to be learned from the withdrawal of Vioxx R® (rofecoxib) (2005) European Journal of Epidemiology, 20, pp. 127-129; Classen, D.C., Pestotnik, S.L., Evans, S., Loyd, J.F., Burke, J.P., Adverse drug events in hospitalized patients (1997) JAMA, 227, pp. 301-306; Collins, T.F., History and evolution of reproductive and developmental toxicology guidelines (2006) Curr. Pharm. Des., 12, pp. 1449-1465; Curran, W.J., The thalidomide tragedy in Germany: The end of a historic medicolegal trial (1971) N. Engl. J. Med., 284, pp. 481-482; Curtis, S., Mukhopadhyay, S., Ramey, D., Reicin, A.S., Etoricoxib cardiovascular safety summary (2003) Circulation, 108, pp. 378-379; Dogne, J.M., Hanson, J., Supuran, C., Pratico, D., Coxibs and cardiovascular side-effects: From light to shadow (2006) Curr. Pharm. Des., 12, pp. 971-975; Farkouh, M.E., Kirshner, H., Harrington, R.A., Ruland, S., Verheugt, F.W., Schnitzer, T., Burmester, G.R., Chesebro, J.H., Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: Randomized controlled trial (2004) Lancet, 364, pp. 675-684; Graham, D.J., Campen, D., Hui, R., Spence, M., Cheetham, C., Levy, G., Shoor, S., Ray, W.A., Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: Nested case-control study (2005) Lancet, 365, pp. 475-481; Hawkey, C.J., COX-2 inhibitors (1999) Lancet, 353, pp. 307-314; Jack, D., Pre-20th century evidence for the placental passage of drugs (2005) Drug News Perspect., 18, pp. 222-224; Juni, P., Nartey, L., Reichenbach, S., Sterchi, R., Dieppe, P.A., Egger, M., Risk of cardiovascular events and rofecoxib: Cumulative meta-analysis (2004) Lancet, 364, pp. 2021-2029; Latest Pharmaceutical News, , http://www.drugs.com/news.html, Accessed at on 28th May 2006; Mann, R.D., Andrews, E.B., Introduction (2002) Pharmacovigilance, pp. 3-5. , R. Mann and E. Andrews, eds, Wiley, London; Maxwell, S.R.J., Webb, D.J., COX-2 selective inhibitors-important lessons learned (2005) Lancet, 365, pp. 449-451; Ostor, A.J., Hazleman, B.L., The murky waters of the coxibs: A review of the current state of play (2005) Inflammopharmacology, 13, pp. 371-380; Rawlins, M.D., Predicting the future from lessons of the past (1997) Int. J. Pharm. Med, 1, pp. 37-40; Rawlins, M.D., Jefferys, D.B., Study of United Kingdom product licence applications containing new active substances (1987) BMJ, 302, pp. 223-225; Silverstein, F.E., Faich, G., Goldstein, J.L., Simon, L.S., Pincus, T., Whelton, A., Makuch, R., Geis, G.S., Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis. the CLASS study: A randomized controlled study (2000) JAMA, 284, pp. 1247-1255; Sooriakumaran, P., COX-2 inhibitors and the heart: Are all coxibs the same? (2006) Postgrad. Med. J., 82, pp. 242-245; http://www.fda.gov/cder/drug/infopage/default.htm, Accessed at on 27th May 2006; Waller, P.C., Making the most of spontaneous adverse drug reaction reporting (2006) Basic Clin. Pharmacol. Toxicol., 98, pp. 320-323; Waller, P.C., Tilson, H.H., Managing drug safety issues with marketed products (2004) Stephen's Detection of New Adverse Drug Reactions, pp. 345-374. , J. Talbot and P. Waller, eds, Wiley, London; Wolfe, M.M., Lichtenstein, D.R., Singh, G., Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs (1999) N. Engl. J. Med., 340, pp. 1888-1899; Wong, Y.L., Adverse effect of pharmaceutical recipients in drug therapy (1993) Ann. Acad. Med., 22, pp. 99-102

PY - 2006

Y1 - 2006

N2 - Drug safety constitutes the cornerstone of modern therapeutics. Nowadays, the focus tends to be more on the hazards of drugs rather than on their benefits. This article describes from a healthcare professional's viewpoint the history behind two major drug disasters: thalidomide and rofecoxib and the reasons why drug withdrawals continue, taking the classic example of rofecoxib despite our safety concerns and the method to overcome those disasters in the future. The paper highlights the major steps to be followed for pharmacovigilance as an effective component of drug safety. The responsibility of healthcare professionals has ultimately to do with patient care and is to promote a culture of safe and efficacious drug use and thereby preventing future disasters related to modern therapeutics. © 2006 - IOS Press and the authors. All rights reserved.

AB - Drug safety constitutes the cornerstone of modern therapeutics. Nowadays, the focus tends to be more on the hazards of drugs rather than on their benefits. This article describes from a healthcare professional's viewpoint the history behind two major drug disasters: thalidomide and rofecoxib and the reasons why drug withdrawals continue, taking the classic example of rofecoxib despite our safety concerns and the method to overcome those disasters in the future. The paper highlights the major steps to be followed for pharmacovigilance as an effective component of drug safety. The responsibility of healthcare professionals has ultimately to do with patient care and is to promote a culture of safe and efficacious drug use and thereby preventing future disasters related to modern therapeutics. © 2006 - IOS Press and the authors. All rights reserved.

M3 - Article

VL - 18

SP - 219

EP - 230

JO - International Journal of Risk and Safety in Medicine

JF - International Journal of Risk and Safety in Medicine

SN - 0924-6479

IS - 4

ER -