Was Eliquis Ever Permanently Recalled or Withdrawn?
The central misconception surrounding Eliquis is that it was withdrawn or permanently recalled due to safety issues. This is incorrect. Eliquis remains a widely prescribed medication and continues to be available today for its approved uses. The public confusion likely stems from a combination of real, but limited, events that occurred over the drug's history, none of which resulted in a permanent market removal.
The 2017 Voluntary Lot-Specific Recall
One of the events often misconstrued as a full market withdrawal was a voluntary recall that occurred in 2017. The manufacturer, Bristol-Myers Squibb, recalled a single lot of Eliquis 5 mg tablets after a customer reported finding bottles that were mislabeled and actually contained the 2.5 mg tablets.
- Reason: The recall was due to a packaging error, not a fundamental flaw with the drug itself.
- Scope: It was a limited, lot-specific recall and did not affect other batches of Eliquis.
- Risk: Patients who received the wrong dosage could be at risk. For example, those prescribed 5 mg but receiving 2.5 mg would have an increased risk of blood clots or stroke due to underdosing.
- Resolution: The issue was addressed and the recall completed, with the FDA terminating the action in 2017.
FDA Delays and Clinical Trial Allegations
Prior to its initial approval, Eliquis faced significant scrutiny from the U.S. Food and Drug Administration (FDA).
- Initial Delay: In 2012, the FDA's approval process was delayed by nine months as the agency investigated misconduct and data errors at a clinical trial site in China.
- Outcome: Ultimately, the FDA concluded that the misconduct did not affect the trial's overall results and granted approval for Eliquis in December 2012.
- Lawsuit Basis: Critics and plaintiffs in later lawsuits cited these trial flaws, alleging that manufacturers misrepresented the drug's safety and effectiveness.
Product Liability Lawsuits and Antidote Availability
Eliquis, like all blood thinners, carries a risk of serious, potentially fatal, bleeding. For several years after its market entry, there was no approved antidote to reverse its anticoagulant effects in emergency situations. This led to a wave of product liability lawsuits.
- Allegations: Lawsuits accused manufacturers of failing to adequately warn patients and doctors about the bleeding risks and the lack of a reversal agent.
- Antidote Development: In 2018, the FDA approved Andexxa, a reversal agent for both Eliquis and Xarelto, which significantly improved the safety profile for patients needing emergency bleeding control.
- Lawsuit Resolution: A federal court dismissed all Eliquis lawsuits in a multidistrict litigation in 2019, ruling that federal law, which approved the drug's label, pre-empted state-based consumer protection claims.
The CVS Caremark Formulary Dispute
In early 2022, CVS Caremark, a major pharmacy benefit manager (PBM), removed Eliquis from its list of covered drugs, known as a formulary. This was a decision based on cost negotiations, not safety, and caused widespread concern among patients and healthcare providers.
- Industry Pressure: Following objections from patient advocacy groups and professional medical organizations, CVS Caremark reversed its decision and reinstated Eliquis to its formulary later that year.
- Not a Recall: This formulary issue was an insurance coverage problem, not a drug recall or market withdrawal, but contributed to the overall public confusion.
Comparison of Eliquis Controversies vs. a Market Withdrawal
| Aspect | Eliquis Controversies | Hypothetical Drug Market Withdrawal |
|---|---|---|
| Reason | Targeted issues: Specific packaging error, clinical trial allegations, product lawsuits, and insurance formulary negotiations. | Broad safety concerns: A systemic, widespread, and confirmed safety issue with the drug itself, such as a dangerous and irreversible side effect. |
| Scope | Limited impact: Affected a single manufacturing lot, involved a subset of legal cases, or impacted specific insurance plans. | Widespread impact: Affects all patients and all batches of the medication nationwide, requiring removal from all pharmacies and treatment protocols. |
| Duration | Temporary/contained: The mislabeled product was voluntarily recalled and the formulary issue was reversed. The lawsuits were dismissed. | Permanent: The drug is permanently removed from circulation and is no longer available for new prescriptions or refills. |
| Resolution | Drug remains available: Following resolution of the specific issues, Eliquis remained on the market and available to patients. | Alternative needed: The drug is no longer an option, and alternative treatments must be sought. |
Conclusion
The notion that Eliquis was taken off the market is a widespread inaccuracy. The drug has faced its share of challenges, including a packaging recall, legal actions, and coverage disputes, which understandably raised alarms among patients and the public. However, at no point did the FDA or the manufacturers permanently remove Eliquis from circulation based on its inherent safety or efficacy. The addition of an antidote in 2018 addressed one of the most significant initial concerns, and the drug continues to be a standard treatment for blood clot prevention. As with any medication, patients should discuss all potential risks and benefits with their healthcare provider.
For additional information and official safety alerts, refer to the FDA website.
