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={Man C. Fung and A. Thornton and Kathy Mybeck and Jasmanda Wu and Kenneth 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A descriptive analysis was conducted to evaluate prescription drugs withdrawn from worldwide pharmaceutical markets over the past four decades due to safety reasons.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 Among the 121 products identified, 42.1% were withdrawn from European markets alone, 5.0% from North America, 3.3% from Asia Pacific, and 49.6% from markets in multiple continents.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… 

Figures and Tables from this paper

Drug withdrawal due to safety reasons: A review of the data supporting the withdrawal decision.

There is no gold standard to identify risks associated with drug exposure and the role of different information sources within the drug safety review process is strengthened, according to available and published evidence.

Correlation between Drug Market Withdrawals and Socioeconomic, Health, and Welfare Indicators Worldwide

The wide variation in the numbers of drug withdrawals and restrictions among countries indicates the need to improve drug surveillance systems and regulatory communication networks.

Can pharmacogenetics help rescue drugs withdrawn from the market?

  • R. Shah
  • Medicine, Biology
    Pharmacogenomics
  • 2006
The criteria that a drug would need to fulfill, and the likely regulatory requirements, before its pharmacogenetic rescue can be considered to be realistic are discussed, and one drug that fulfils these criteria is perhexiline and is discussed in some detail.

ADVERSE DRUG REACTIONS: AN OVERVIEW OF THE OLD AND CONTINUOUS CHALLENGE TO DRUG THERAPY AND DEVELOPMENT

An overview of the currently used definitions and classifications of ADRs in clinical pharmacology and toxicology and a special emphasis is made on the importance of ADR in clinical drug therapy and drug development, which are the areas where ADRs play the most significant role.

Overview and Comparison of Postmarketing Drug Safety Surveillance in Selected Developing and Well-Developed Countries

The improvement of drug safety surveillance in the developing countries requires increasing awareness, positive regulatory policy, improving the infrastructure, and better strategies to create a functioning pharmacovigilance system.

Pharmacogenetics of drugs withdrawn from the market.

With an emphasis on the mechanisms underlying abnormal drug effects caused by genetic mutations, pharmacogenetic studies may enhance the safety and effectiveness of drug use, provide more comprehensive delineations of the scope of usage, and change the fates of drugs withdrawn from the market.

Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions.

This work analyzed all reports of suspected adverse drug reactions submitted to the Food and Drug Administration from the inception of the Adverse Event Reporting System database in 1969 through December 2002 to encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adversedrug reactions to manufacturers and the food and drug Administration.

Clinical perspectives in drug safety and adverse drug reactions

  • P. Pillans
  • Medicine
    Expert review of clinical pharmacology
  • 2008
In an attempt to improve vigilance, international surveillance may benefit by moving from its current passive/reactive mode toward active surveillance systems with a prospective, comprehensive and systematic approach to monitoring, collecting, analyzing and reporting data on ADRs.

Prediction on the risk population of idiosyncratic adverse reactions based on molecular docking with mutant proteins

This study searched for and obtained the Dilevalol-induced- liver-injury related protein, multidrug resistance protein 1 (MDR1), from the Comparative Toxicogenomics Database (CTD) and extracted 477 non-synonymous single nucleotide polymorphisms (nsSNP) on MDR1 in the dbSNP database, and built the three-dimensional structures of those variant proteins and used AutoDock to perform a docking study.

Black Box Warnings and Drug Safety: Examining the Determinants and Timing of Fda Warning Labels

A comparison of NMEs approved before and after the 1992 Prescription Drug User Fee Act (PDUFA), which authorized the payment of user fees from drug manufacturers to the FDA in an effort to expedite new drug application review times, did not reveal a statistically significant difference in the rate of BBWs.
...

References

SHOWING 1-10 OF 106 REFERENCES

Drug discontinuations in the United Kingdom and the United States, 1964 to 1983: Issues of safety

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.

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
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.

Worldwide Regulations for Manufacturers on Clinical Safety Surveillance of Drugs

There is a compelling need for standardization among regulatory bodies of the definitions and requirements in this important public health area and approaches initiated by The Council for International Organizations of Medical Sciences are discussed as a reasonable approach.

The safety of newly approved medicines: do recent market removals mean there is a problem?

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.

Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan.

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.

New active substances authorized in the United Kingdom between 1972 and 1994.

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.

Is the FDA approving drugs too fast?

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.

Evaluation of the efficacy and safety of NSAIDs. A new methodological approach.

  • H. Fenner
  • Medicine
    Scandinavian journal of rheumatology. Supplement
  • 1989
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.

Examining product risk in context. Market withdrawal of zomepirac as a case study.

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.
...