Healthy Skepticism Library item: 10432

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

New drugs: watch out for unexpected adverse effects.
Prescrire Int. 2002 Oct; 11:(61):150-1
http://www.ncbi.nlm.nih.gov/pubmed/12378747

Abstract:

(1) Some serious adverse drug reactions only emerge once a drug has been released on to the market. (2) 10% of the new drugs marketed in the United States over the last 25 years were subsequently withdrawn or were the subject of major warnings about serious or life-threatening side effects. The number of patients affected is unknown. (3) Patients must not be placed at risk because doctors prescribe a new drug when a reliable alternative is available or when the condition treated is mild. (4) Prevention should be based on improved quality of clinical trials and on upgraded procedures for marketing approval. Other measures include encouraging the correct use of recently marketed drugs; closer monitoring of these drugs; better notification of side effects; and improved quality and transparency of pharmacovigilance data.

Keywords:
Adverse Drug Reaction Reporting Systems Clinical Trials Drug Approval Drug Therapy/adverse effects* France Humans Product Surveillance, Postmarketing* Risk Management United States