Systematic identification of drugs that cause birth defects--a new opportunity

Article Abstract:

The US Food and Drug Administration (FDA) should take advantage of the third Prescription Drug User Fee Act, approved by Congress in 2002, to implement a nationwide teratogen surveillance system that can identify drugs that may cause birth defects. This act requires pharmaceutical companies to pay a fee to support the drug review process. This money could be used to set up the data collection infrastructure and empower an advisory committee to oversee the collection of follow-up and case-control data that would identify drugs that may harm an unborn baby.

Causes of, Birth defects

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Population-based studies of adverse drug effects

Article Abstract:

Doctors must come up with better ways of monitoring adverse reactions to drugs. Pharmaceutical companies must evaluate all drugs before they are marketed, but this cannot detect many rare adverse events. These must be identified in the post-marketing phase. This may require studying large groups of people, comparing those who take a specific drug with those who do not.

Research and Development in the Physical, Engineering, and Life Sciences, Research and Testing Services, Medical Research, Epilepsy & Muscle Disease R&D, Administration of Public Health Programs, Health Research Programs, Medicine, Experimental

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Adverse outpatient drug events -- a problem and an opportunity

Article Abstract:

A study published in 2003 found that many people who take medications on an outpatient basis may have an adverse reaction to some of the drugs. However, many side effects of drugs are symptoms that can occur even in people who don't take the drug. So it is difficult to say whether the symptom is actually drug-related.

Editorial, Ambulatory medical care, Ambulatory care

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