The Propafenone Hydrochloride Recall

Propafenone Hydrochloride (Propafenone HCI) is an anti arrhythmic drug that is taken orally. It comes in tablets that are film coated and scored. The tablets come in doses of 150 mg, 225 mg and 300 mg. In November 2008, the Ethex Corporation which manufactures Propafenone HCI voluntary recalled certain batches of this medication due to the potential for overdoses.

How to Identify Recalled Tablets

The November 2008 recall applied to drugs that were sent to distributors, such as pharmacists, prior to May 22, 2008. While distributors were asked to send the drugs back to the Ethex Corporation in November 2008, some of the affected drugs had already been sold to patients.

The affected tablets can be identified as follows:

• 150 mg tablets: white, scored round filmed tablet with ETH on one side and 331 on the other side;
• 225 mg tablets: look the same as 150 mg tablets except instead of 331, they read 332; and
• 300 mg tablets: look the same as 150 mg tablets except instead of 331, they read 333.

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Why Were the Drugs Recalled?

In November 2008, Propafenone HCI Tablets of 150 mg, 225 mg and 300 mg were voluntarily recalled by Ethex Corporation, the medication’s manufacturer, with the FDA’s knowledge.

The recall notice states that some batches of Propafenone tablets that were sent to distributors such as pharmacists contained tablets that were oversized. The company stated that each pill could contain as much as two times the recommended dose. The resulting overdose could be dangerous for patients and result in serious or life threatening situations. Therefore, patients were urged to discard the medication and refill their prescriptions from batches not affected by the recall.

Adverse Reactions

The three most common types of adverse reactions from an overdose of this drug are cardiovascular, gastrointestinal and problems with the central nervous system. Symptoms could include nausea, vomiting, dizziness, constipation, headaches, fatigue, blurred vision and weakness, for example. If the drug is affecting a patient’s central nervous system then the patient might experience strange dreams, abnormal speech, confusion, depression, psychosis, vertigo or other symptoms.

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Symptoms of an overdose

The most serious concerns about an overdose of Propafenone HCI are the risks of arrhythmias and low blood pressure. Symptoms of an overdose are typically at their worst about 3 hours after ingestion. Any of the common adverse reactions might occur. Further, patients should be particular cognizant of symptoms that include hypotension, somnolence, bradycardia and, intra-atrial and intraventrical conduction disturbances.

It is important that a Propafenone HCI overdose is treated promptly. Patients who suspect an overdose should proceed to the hospital. Defibrillation, convulsions and cardiac massage may be necessary to counteract the overdose effects.

If you have any concerns about your supply of Propafenone HCI, you should immediately stop taking the medication and refill your prescription.

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