FDA Speeds Up Availability of New Drug Safety Information

FDA Speeds Up Availability of New Drug Safety Information

The FDA has sped up how quickly new safety information that arises on prescription drugs can get to people.

Before, the FDA would update a database based on self-reported side effects and drug interactions from doctors and patients. That database is a part of the Drug Safety Labeling Changes Program that used to include new information only once a month. Now the agency says its recent improvement “enables the FDA to post the latest safety information about a medicine almost at the same time we approve a change.”

Drug labeling is best explained as the small print details you get with your prescription when it is filled. It contains information such as what the drug is used for, side effects one may experience with it, drugs that may interact with it. In some cases, strong warnings if there have been adverse events reported during clinical trials and since the drug has hit the market are contained in a “black box” at the beginning of the labeling.

“Safety information can change multiple times over the lifetime of a drug as FDA learns about new risks, interactions with other medications and side effects,” Mary E. Kremzner, PharmD, MPH, U.S. Public Health Service and director of the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research,” wrote in a blog post.

A drug’s labeling is usually changed at least several times while available on the market.

If you are concerned about a medication you are taking and want to see if labeling has been updated as a result of side effect issues to have been brought to the attention to the FDA, visit the agency’s searchable Drug Safety Labeling Changes database.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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