Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999*

@article{Fung2001EvaluationOT,
  title={Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999*},
  author={M. Fung and A. Thornton and K. Mybeck and Jasmanda Wu and K. Hornbuckle and Edmundo Mu{\~n}iz},
  journal={Therapeutic Innovation \& Regulatory Science},
  year={2001},
  volume={35},
  pages={293 - 317}
}
A descriptive analysis was conducted to evaluate prescription drugs withdrawn from worldwide pharmaceutical markets over the past four decades due to safety reasons. The list of drugs, including indication, the duration of marketing, and reasons for withdrawal were examined. Among the 121 products identified, 42.1% were withdrawn from European markets alone, 5.0% from North America, 3.3% from Asia Pacific, and 49.6% from markets in multiple continents. Distributions of these withdrawals in each… Expand
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References

SHOWING 1-10 OF 118 REFERENCES
Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A regulatory perspective
TLDR
The therapeutic classes most commonly associated with safety discontinuations were the nonsteroidal anti‐inflammatory drugs, vasodilators, and antidepressants, and U.S. companies or their foreign subsidiaries were involved as originators (patent‐holders and/or developers) of approximately 40% of the drugs discontinued for safety reasons. Expand
Drug discontinuations in the United Kingdom and the United States, 1964 to 1983: Issues of safety
TLDR
Since drugs discontinued while a safety question existed represent only 2% of the new chemical entities introduced, it appears that drugs that reach the market under the prevailing regulatory systems are seldom associated with unacceptable toxicity. Expand
Comparison of the Safety of Several Nonsteroidal Anti‐inflammatory Drugs Currently or Formerly Marketed in the United Kingdom
  • C. Speirs
  • Medicine
  • Journal of clinical pharmacology
  • 1988
TLDR
It is concluded that anomalies in the frequency and pattern of suspected drug‐related adverse reactions in the absence of any confounding factor are an important signal of the need for further investigation. Expand
Worldwide Regulations for Manufacturers on Clinical Safety Surveillance of Drugs
It has become increasingly difficult, especially for multinational pharmaceutical companies, to remain current and comply efficiently with the multiplicity of regulations and guidelines in variousExpand
The safety of newly approved medicines: do recent market removals mean there is a problem?
TLDR
The agency's drug review procedures and postmarketing surveillance system after a drug has been marketed are currently adequate but must continually adjust to future challenges. Expand
Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan.
TLDR
Analysis of the marketing approval dates of 214 drugs newly introduced into the world market from January 1990 through December 1994 reveals that the United States and the United Kingdom have similar patterns of drug availability, although the United United States has a number of therapies with significant public health benefits that are not yet available in the United UK. Expand
New active substances authorized in the United Kingdom between 1972 and 1994.
TLDR
There is marked heterogeneity in the annual rates of authorisation of new active substances, and the provisional nature of assessments about safety at the time when a new active substance is introduced into routine clinical practice is confirmed, confirming the importance of pharmacovigilance. Expand
Is the FDA approving drugs too fast?
TLDR
The Food and Drug Administration has been accused of delaying drug approvals: now it is accused of acting too hastily in approving drugs that have later had to be withdrawn. Expand
Evaluation of the efficacy and safety of NSAIDs. A new methodological approach.
  • H. Fenner
  • Medicine
  • Scandinavian journal of rheumatology. Supplement
  • 1989
TLDR
An overview of the methodology which is now used in the development of a NSAID is discussed, using data and procedures obtained from the evaluation of tenoxicam. Expand
Examining product risk in context. Market withdrawal of zomepirac as a case study.
TLDR
The sudden withdrawal of zomepirac from the market resulted in substitutions not only of other NSAIDs, but also of alternative analgesics that carry risks of habituation and adverse effects. Expand
...
1
2
3
4
5
...