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U.S. FDA Requiring Digital Drug Labels
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WASHINGTON (Reuters) Nov 02 - Drug makers must begin submitting electronic versions of their drug labels to build a database that doctors and patients can search for recent warnings or other changes, the U.S. Food and Drug Administration said on Wednesday.

The labels will be available on the Internet within one business day of any FDA-approved change at http://dailymed.nlm.nih.gov FDA officials said in a statement.

"With this information, physicians will be able to quickly search and access specific information they need before prescribing a treatment, allowing for fewer prescribing errors and better informed decision making," the FDA said.

Digital versions of drug labels must be provided to the FDA when either a label change is made or as part of a yearly report that pharmaceutical companies provide the agency.

It will take a year for the roughly 9,000 U.S.-approved prescription drugs to have their new labels put online, FDA spokeswoman Kristen Neese said.

Drug labels are usually designed as small pamphlets included with the medicine and are known for their small print.

The labels include information on how the medicine works, what dose patients should take, possible side effects and, sometimes, warnings against its use in certain people or under specific conditions.

The FDA says the new Internet format will allow people to more easily navigate through the information by jumping directly to certain sections.

The FDA will next require similar digital label formats for nonprescription drugs and eventually for medical devices, animal drugs, some food products and biologic drugs such as vaccines, said Neese.

Reuters Health Information 2005. © 2005 Reuters Ltd.

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