Has there been a recall on Pradaxa?

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). The recall is limited to this one lot number. This recall is being conducted due to a potential packaging defect on this lot that may compromise the bottle integrity.

Was Pradaxa taken off the market?

After more than a thousand Pradaxa-related casualties, it is shocking that neither Boehringer Ingelheim nor the FDA ever took Pradaxa off the market. Pradaxa’s antidote was several years overdue, and hundreds of people died as a result.

Why does Pradaxa carry a FDA warning?

[12-19-2012] The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also …

Is dabigatran FDA approved?

Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least …

What drug company makes Pradaxa?

Boehringer Ingelheim Pharmaceuticals, Inc. Announces Updates to Prescribing Information for Pradaxa® (dabigatran etexilate mesylate) | boehringer-ingelheim.us.

What happened to Pradaxa?

Life-Threatening Bleeding Reported The U.S. Food and Drug Administration approved the drug in 2010. More than 540 people who took Pradaxa died in 2011. Thousands of other people reported suffering from serious side effects that year.

What are the side effects of dabigatran?

The most common side effect of dabigatran is bleeding more easily than normal, such as having nosebleeds, bleeding gums and bruising. It tends to happen in the first few weeks of treatment or if you’re unwell. Always carry your anticoagulant alert card with you.

What is the brand name for dabigatran?

Dabigatran is used to prevent blood clots from forming because of a certain irregular heart rhythm (atrial fibrillation). Preventing these blood clots helps to reduce the risk of a stroke. Dabigatran is available under the following different brand names: Pradaxa.

When was dabigatran approved by the FDA?

Approval Date: 10/19/2010.

What drugs did FDA approve?

All Approvals and Tentative Approvals October 2021

Is dabigatran a DOAC?

Direct oral anticoagulants (DOACs)—dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa) are anticoagulation pharmacotherapy used for the prevention of thrombosis in several cardiovascular contexts.

When did the FDA approve dabigatran 150 mg?

In October 2010, the Food and Drug Administration (FDA) approved the novel antithrombin agent, dabigatran, in a dose of 150 mg twice daily for stroke prevention in nonvalvular AF.

How much dabigatran etexilate is in a 150 mg capsule?

The 150 mg capsule for oral administration contains 172.95 mg dabi gatran etexilate mesylate, which is equivalent to 150 mg of dabigatran etexilate, and the following inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid.

Can a higher dose of dabigatran cause a stroke?

According to the analysis of RE-LY patients with moderate renal impairment (creatinine clearance >30 to 50 mL/min) cited by Beasley et al, the rate of stroke in the higher-dose group was actually half that of the lower-dose group, while bleeding rates were no different.

How long is the half life of dabigatran?

Dabigatran is eliminated primarily in the urine. Renal clearance of dabigatran is 80% of total clearance after intravenous administration. After oral administration of radiolabeled dabigatran, 7% of radioactivity is recovered in urine and 86% in feces. The half-life of dabigatran in healthy subjects is 12 to 17 hours.