Routine Updates to Drug Labeling Still Cause For Concern

July 30, 2019 - What some consumers may not realize is that the FDA releases approved safety-related labeling changes through their website on a regular basis. As a matter of fact, this month there were changes to over 50 different medications.

It should go without saying, but updates to our drug labels are incredibly important. These updates provide healthcare providers and consumers like you with new information about critical warnings or precautions, black box warnings and updates on how to prescribe certain medications to special populations, like pregnant women and children. The updates help with decision making and help people to monitor what they should look out for while taking a drug. However, these updates also raise more concerns than not. One question that can easily be raised is why are these updates happening now and is there a system in place to ensure consumers (not just healthcare providers) know about these changes right away?

Safest Drug’s position is that these safety labeling changes must be communicated to anyone who has taken the medication as soon as those are made available. Any consumer would want to know if their medication had new warnings. It’s a no brainer. Additionally, these safety labeling changes highlight how much is not known about a medication until it is on the market and being taken by a much larger consumer population than when the drug was tested in a small population of human subjects prior to FDA approval.

We will continue to monitor these safety labeling changes but, for now, here is a snapshot of the specifically named medications that had approved updates to their labeling this month:

Adderall XR 10

Albenza

Anaprox

Atropine (Autoinjector)

Aubagio

Austedo

Avonex

Bevyxxa

Caldolor

Cerebyx

Copaxone

Darzalex

Dextrose 5% and Potassium Chloride 0.3% in Plastic Container

Dilantin-125

Docetaxel

Droxia

Duexis

EC-Naprosyn

Exjade

Gadavist

Glyxambi

Heparin Sodium 1,000 Units & Sodium Chloride 0.9% in Plastic Container

Imfinzi

Janumet

Janumet XR

Januvia

Jentadueto

Jentadueto XR

Jeuveau

Kazano

Kombiglyze XR

Lialda

Lymphoseek Kit

Megace

Mekinist

Naprelan

Naprosyn

Nesina

Ocrevus

Onglyza

Oseni

Pentasa 

Plegridy

Potassium Chloride

Qtern

Qternment XR

Rapamune

Rebif

Serevent

Steglujan

Tafinlar

Tecfidera

Tradjenta

Treximet

Trintellix

Vimovo

Zyban

Do you recognize any from the list?

To search the FDA’s safety labeling changes database and review exactly what was updated for any of these medications, click here.

Safest Drug is a 501(c)(3) non-profit on a mission to implement solutions that help to prevent and alleviate medication-related illness, disability and death. We plan to do this as consumer-focused advocates that lead education, community engagement, policy and research initiatives to better protect consumers, promote the voice of consumers' medication safety experiences and broaden the understanding of what it means to be medicated in America.

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