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FDA.gov

Collected by: U.S Food and Drug Administration

Archived since: Oct, 2016

Description:

Snapshot of the www.FDA.gov website

Subject:   Science & Health Government - US Federal

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Pradaxa (dabigatran etexilate mesylate) capsules

URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm250657.htm

This text was captured  on Apr 06, 2017   Show All Captures

Therefore, use of PRADAXA is not recommended in these patients.

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Pradaxa (dabigatran etexilate mesylate) capsules

URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm250657.htm

This text was captured  on Jan 12, 2017   Show All Captures

Therefore, use of PRADAXA is not recommended in these patients.

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FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa

URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm

This text was captured  on Jan 25, 2018   Show All Captures

Praxbind and Pradaxa are both marketed by Boehringer Ingelheim of Ridgefield, Connecticut. The FDA, an agency within the U.S.

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FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm

This text was captured  on Jan 11, 2017   Show All Captures

Praxbind and Pradaxa are both marketed by Boehringer Ingelheim of Ridgefield, Connecticut. The FDA, an agency within the U.S.

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Information on Dabigatran Etexilate Mesylate (marketed as Pradaxa)

URL: https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm248694.htm

This text was captured  on Nov 01, 2017   Show All Captures

bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) [ARCHIVED] 12/8/2011 FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa

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FDA Drug Safety Podcast: Update on the risk for serious bleeding events with the anticoagulant Pradaxa

URL: https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm326863.htm

This text was captured  on Jul 22, 2017   Show All Captures

Following the approval of Pradaxa , FDA received a large number of post-marketing reports of bleeding among Pradaxa users.

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FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran)

URL: http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm

This text was captured  on Jan 12, 2017   Show All Captures

The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin.

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FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran)

URL: https://www.fda.gov/Drugs/DrugSafety/ucm326580.htm

This text was captured  on Apr 06, 2017   Show All Captures

The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin.

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FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules

URL: https://www.fda.gov/Drugs/DrugSafety/ucm248746.htm

This text was captured  on Jul 26, 2018   Show All Captures

Do not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers. For Pradaxa bottles: Open only one bottle of Pradaxa at a time.

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FDA Drug Safety Podcast: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

URL: https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333209.htm

This text was captured  on Apr 06, 2017   Show All Captures

There was also more bleeding after valve surgery in the Pradaxa users than in warfarin users. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.

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Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves

URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332949.htm

This text was captured  on Jan 12, 2017   Show All Captures

There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.

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FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules

URL: http://www.fda.gov/Drugs/DrugSafety/ucm248746.htm

This text was captured  on Jan 12, 2017   Show All Captures

Do not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers. For Pradaxa bottles: Open only one bottle of Pradaxa at a time.

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FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules | FDA

URL: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-special-storage-and-handling-requirements-must-be-followed-pradaxa

This text was captured  on Dec 25, 2020   Show All Captures

Do not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers. For Pradaxa bottles: Open only one bottle of Pradaxa at a time.

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