Carvedilol Tablets Recalled Due to Cancer-Causing Impurity - Risks Explained

The Carvedilol Recall of 2022 Explained

In September 2022, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several lots of carvedilol tablets manufactured by Apotex Corp. Carvedilol is a beta blocker used to treat high blood pressure and heart failure. The recall was issued due to nitrosamine impurity contamination, which is associated with potential cancer risk with long-term exposure.

What is Carvedilol?

Carvedilol is classified as a non-selective beta blocker, meaning it blocks the effects of the hormone epinephrine (adrenaline) on both beta-1 and beta-2 receptors in the body. This causes the heart to beat slower and with less force, thereby lowering blood pressure. Carvedilol also causes blood vessels to relax and widen, improving blood flow.

In addition to treating high blood pressure, carvedilol is also prescribed for chronic heart failure, as it can improve the hearts pumping ability. It is sold under the brand names Coreg, Coreg CR, and generic formulations.

What Caused the Carvedilol Recall?

The recall was prompted due to the detection of a nitrosamine impurity called N-nitroso-diethylamine (NDEA) in several lots of carvedilol tablets. Nitrosamines are common but potentially harmful compounds found in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some amount of nitrosamines regularly.

However, a drug contaminated with high levels of nitrosamines carries an increased risk of cancer if consumed over long periods of time. Although the actual cancer risk is difficult to determine, the FDA has a zero tolerance policy for avoidable nitrosamine contamination.

Which Products Have Been Recalled?

The recall applies to all non-expired lots of the following carvedilol tablet products packaged in HDPE bottles by Apotex Corp:

• Carvedilol 3.125 mg tablets
• Carvedilol 6.25 mg tablets
• Carvedilol 12.5 mg tablets
• Carvedilol 25 mg tablets

The affected lots were distributed nationwide to wholesalers, distributors, retailers and repackagers between February and September 2022. A full list of recalled lot numbers is available on the FDA website.

What Are the Health Risks?

Based on available data, the nitrosamine levels detected in recalled carvedilol lots only slightly exceed what is considered an acceptable intake level. Still, the health risk associated with long-term use cannot be dismissed.

Exposure to high levels of nitrosamines over many years is linked to an increased risk of developing certain cancers, including of the stomach, esophagus, liver and bladder. However these cancers generally take decades to develop.

The FDA has assessed that the recalled products are not likely to cause harm when taken for short periods of time. Patients currently taking carvedilol should continue taking their medication until speaking with their doctor about alternatives.

What You Should Do

If you currently take carvedilol tablets, check your bottles against the list of recalled lots published by the FDA. Any medication from a recalled lot should be disposed of properly.

Do not simply throw away recalled medication or flush it down the toilet. You can take it to a drug take-back site or use a drug disposal product to neutralize the drugs before throwing them away. Ask your pharmacist for guidance on proper disposal methods.

If you have tablets from a recalled lot, contact your doctor or pharmacist immediately to discuss switching to an alternative medication to treat your high blood pressure or heart failure.

Be aware that suddenly stopping carvedilol without a replacement can be dangerous, so do not stop any medication before speaking to your healthcare provider. Adverse effects associated with abrupt carvedilol withdrawal include chest pain, heart attack, irregular heartbeat and a return of high blood pressure symptoms.

Report any health issues experienced while taking carvedilol tablets to the FDA's MedWatch Adverse Event Reporting program. The FDA will continue testing and monitoring the drug supply for any other potential nitrosamine contamination issues.

The Bottom Line on the Carvedilol Recall

This carvedilol recall illustrates the challenges involved in ensuring the safety and integrity of the U.S. drug supply chain. While concerning, the nitrosamine levels detected likely do not pose an imminent health threat given the typical short-term use of these blood pressure medications.

That said, recalls are disruptive for patients and doctors alike. Stay alert for any notifications about medications you take, be diligent about disposing recalled drugs properly, and work with your healthcare providers to find suitable alternative treatments.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.