Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentHow the manual was produced
View the documentAbout ISDB
View the documentExecutive summary
Open this folder and view contents1. Introduction
Open this folder and view contents2. Rational use of medicines
Open this folder and view contents3. What are drug bulletins?
Open this folder and view contents4. Defining aims, target and type of bulletin
Open this folder and view contents5. Planning resources
Open this folder and view contents6. Planning bulletin production: schedules and timing
Open this folder and view contents7. The editorial process
Open this folder and view contents8. Reviewing a new drug: is it a therapeutic advance?
Close this folderAnnexe to Chapter 8: Evaluating harm
View the document8.An-1 Talk about harm, not risk
View the document8.An-2 Assessment of causation of a harmful effect
Close this folder8.An-3 Assessing coherence with preclinical data
View the document8.An-3.1 General principles
View the document8.An-3.2 Chemical structure of new drugs
View the document8.An-3.3 Considering the profile of adverse effects
View the document8.An-3.4 Ratio of toxic and efficacy level in the same animal
View the document8.An-3.5 Extrapolation of animal toxicity (safety) level to humans
View the document8.An-4 References
Open this folder and view contents9. Design and production
Open this folder and view contents10. Dissemination
Open this folder and view contents11. Organizational and legal issues
Open this folder and view contents12. Evaluating quality and usefulness
Open this folder and view contents13. Partnership and collaboration
Open this folder and view contents14. Keeping records and creating a memory
Open this folder and view contentsAppendix: Electronic sources of information

8.An-3.2 Chemical structure of new drugs

It may be helpful to look at the chemistry of a new drug. Comparing the chemical structure of a new drug with existing drugs may help give an impression of what kind of effects may evolve. This comparison should not be limited to drugs which are marketed for the same indication. (See Box 8.12 for examples).

Box 8.12 Examples of how a drug’s chemical structure can explain its effects

Example 1. In 1990/91 torsade de pointes was reported in connection with the urinary incontinence drug terodiline.

The German bulletin arznei-telegramm realised that terodiline was chemically very close to the antiarrhythmic drug prenylamine which had been withdrawn from the market 10 years earlier because of fatal arrhythmias. After publication of the similarity in the drug structures and the suspicion of parallel adverse effects (arznei-telegramm 1991; no 8: 65) the company withdrew terodiline from the market immediately (arznei-telegramm 1991; no.9: 79). The manufacturer had not been aware of the chemical affinity of the two drugs before this.

Example 2. Atomoxetine is now approved for attention deficit hyperactivity disorder. It had previously been in clinical tests under the International Nonproprietary Name tomoxetine as an antidepressant drug. Atomoxetine has a lot of similarities in chemical structure with serotonin re-uptake inhibitors, like fluoxetine. This may help in understanding and assessing some of the adverse drug reactions, such as aggressive behaviour, which is seen with both drugs [arznei-telegramm 2005; 36: 33-4.].

Contributed by Wolfgang Becker-Brueser, arznei-telegramm, Germany

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