Latest FDA Summary of Warnings Reveals More Consumer Risks

The drugs approved as safe for marketing and prescription to consumers in the U.S. are constantly monitored by the Food and Drug Administration (FDA). The monitoring system is seriously flawed, being little more than the next stage of drug testing "in the wild". This effectively reduces consumers to the level of "lab rat" as their experiences, or some of them anyway, are recognized and reported to the FDA.

If consumers grin-and-bear-it through some unwanted reaction and hence it is not reported or if for any other reason it is not conveyed to the FDA, it will not contribute to knowledge of the drug’s performance. Equally, if the reaction is already well documented it will frequently go unreported.

Nevertheless, every month the FDA releases one more month’s worth of changes to the Contraindications, Boxed Warnings, Warnings, Precautions and Adverse Reactions information associated with the drugs and medical equipment it has previously approved. This data is released in a quite timely fashion actually, but monthly summaries are provided in arrears. For example, the November 2005 summary has just been released.

In this November data some 55 products are included. Eight Contraindcation updates were made, three Boxed Warning updates, 14 Warnings updates, 41 Precautions updates and 17 Adverse Reactions updates. That’s a lot of updates and they represent a lot of problems associated with these approved products. I think this is actually just the tip of the iceberg.

While much of the material is best suited to medical or health professional consumption, there is some value for anyone in perusing the data. In any event, take a look at the scope and the types of problems that the FDA is comfortable continuing to expose consumers to. Their Summary is presented below.

Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) — November 2005

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