Pradaxa® Recall & Risks
Although many people are calling for one, a Pradaxa® recall has not been issued. However, the absence of a recall does not mean Pradaxa® risks should be ignored.
Patients taking the drug should be fully aware of the problems with Pradaxa®, including its side effects, and discuss concerns with their physicians. The number of life-threatening and fatal events associated with Pradaxa® has grown rapidly since the drug’s FDA approval in October 2010.
FDA Regulation of Drugs
The Center for Drug Evaluation and Research (CDER), a part of the FDA, regulates prescription and over the counter drugs, ensuring that the drugs are safe and effective. The CDER does not test drugs for approval. Drug manufacturers are responsible for testing and providing results to the CDER. Experts then review results to determine the drug’s safety and effectiveness before approving.
After a drug is approved by the FDA, the manufacturer must continue to monitor and report any problems with the drug. Consumers and healthcare professionals can report adverse effects of drugs to the FDA using Form FDA 3500. The FDA monitors reports through the Adverse Events Reporting System (AERS), a computerized database.
Recalling Pradaxa® & other Drugs
A recall of Pradaxa® or any other drug can be issued by its manufacturer, requested by the FDA or by FDA order under statutory authority. Recalls are almost always voluntary. In a recall, the manufacturer stops distributing its product and removes it from the market. The public is notified about the recall.
Classification of recalls is as follows:
- Class I: there is reasonable probability that the drug will cause serious adverse health effects or death.
- Class II: the drug may cause temporary or medically reversible adverse health effects or the likelihood of it causing serious adverse health effects is remote.
- Class III: the drug is not likely to cause adverse health effects.
- Market withdrawal: a drug has a minor violation not subject to FDA legal action. The product is removed from the market and violation corrected. Market withdrawal may occur when a product has been tampered with.
FDA Reviewing Pradaxa® Risks
The FDA issued a safety alert December 7, 2011 due to growing post-market reports of Pradaxa® adverse effects. Reports submitted to the AERS database about serious bleeding in patients taking Pradaxa® are being reviewed to determine if the adverse effects are occurring more than expected based on Pradaxa’s clinical trial.
Pradaxa® Recall Not Required for Legal Action
Patients who have suffered serious adverse effects of Pradaxa® are urged to seek the counsel of an experienced pharmaceutical attorney to protect their legal rights. Attorneys with the law firm Watts Guerra Craft are reviewing claims nationwide with the potential for a Pradaxa® lawsuit.
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