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FDA Announces Nationwide Recall of Certain Amiodarone Lots

FDA Announces Nationwide Recall of Certain Amiodarone Lots

The FDA has announced a nationwide recall of several lots of amiodarone manufactured by Mylan NV. Also included in the recall are lots of tranexamic acid injectables. Mylan says the two drugs may have been mislabeled as the other.

Amiodarone HCl Injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (“VT”) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

According to the FDA (as reported by the Cardiovascular Research Foundation), “If amiodarone HCl injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower-than-expected heart rate, which could have immediate life-threatening effects on cardiac function.” Delaying treatment with amiodarone due to accidental use of tranexamic acid would allow for the arrhythmia to continue and could cause death.

On the other hand, “if tranexamic acid injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with tranexamic acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events.”

These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. There is no recall for the tablet form of amiodarone.

The recall comes on the heels of a spate of amiodarone lawsuits filed because of alleged dangerous side effects associated with the drug. Patient safety advocates and lawyers claim that manufacturers have been pushing the drug for unapproved off label uses. The FDA considers the drug a drug of last resort and subject to black box warnings.

The current warning says:


Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. 

Amiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when Amiodarone hydrochloride therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months.

Amiodarone hydrochloride can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue Amiodarone hydrochloride if the patient experiences signs or symptoms of clinical liver injury.

Amiodarone hydrochloride can exacerbate arrhythmias. Initiate Amiodarone hydrochloride in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available.

The recall is voluntary. We remind readers to promptly report any adverse reactions to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

PIC and Dangerous Drugs

We are glad that Mylan reported the mislabeling issue and voluntarily recalled the two drugs that may have been mislabeled.

The larger issue with amiodarone is drug companies that have been peddling the drug for many years for off label uses not approved by the FDA.

If you have knowledge of illegal off labeling of prescription drugs, let us know. We are happy to accept your information anonymously. Our mission is to stop dangerous practices within the pharmaceutical industry, restore integrity to our industry and, where applicable, protect whistleblowers who step forward with important safety information.

To learn more, contact us online or by phone at 202.780.9957. All calls are kept confidential. You need not provide your name. (We remind pharma professionals to be cautious when contacting us from a work device or work email address.)

Related topics: Amiodarone

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