3. Major FDA Warning? Pills
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It is a safety scandal that the most important FDA drug warnings do not reach consumers in a clear and understandable manner. These are risks important enough that they could change the decision to prescribe or take these drugs

Major FDA warnings tell about about serious drug risks such as the ability to cause cancer, stop the heart beat, destroy the liver or cause seizures. For most drugs these adverse events are rare, but still need to be balanced against the need for the drug and its medical benefits.

These are called "boxed warnings" because they appear in a black box at the beginning of the drug label or package insert. (This document is that nearly unreadable, jargon-packed piece of fine print that you can get from the pharmacist if you ask.)

A second kind of FDA warning appears in special black type at the beginning of a section of the drug package insert called WARNINGS. These too are important, and tell of serious risks. Examples are the ability of a drug to cause perforated ulcers, internal bleeding or birth defects.

For a study I once surveyed most of the major consumer guides and many of the information sheets that come from pharmacies. Sometimes the warnings were omitted entirely; in other cases they were buried and watered down so as not to frighten anyone. This is the key problem of drug safety. Any information or clear warning that might interfere with selling more drugs gets left out.

The solution is to ask a pharmacist for the "package insert" for any drugs, especially one that you have just purchased. Look at the beginning of the label for a black box, and get help, if you need it, to puzzle out the true hazard. While you're doing this, also check the section of the label with the heading WARNINGS: Any bold face type in this section is an important warning, but less dire than the boxed warning.

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