Atorvastatin Recalled in 2023 Due to Nitrosamine Impurity

The Atorvastatin Recall in 2023 and What It Means for Patients

In early 2023, several manufacturers voluntarily recalled some of their atorvastatin products over concerns of possible N-nitroso-atorvastatin contamination. Atorvastatin is the generic version of the popular cholesterol-lowering medication Lipitor.

This potential impurity prompted major recalls of certain atorvastatin lots in January 2023. Here is an overview of the atorvastatin recall, what it means for patients, and the steps you should take if impacted.

Background on Atorvastatin

Atorvastatin is in a class of cholesterol medications called statins. It works by inhibiting an enzyme needed for making cholesterol in the body. This lowers LDL “bad” cholesterol and triglyceride levels while raising HDL “good” cholesterol.

Atorvastatin is prescribed to treat:

• High cholesterol
• Heart disease and stroke prevention
• Reducing heart attack and mortality risk

It is one of the most widely prescribed and clinically successful drugs worldwide. However, concerns emerged in 2023 about potential contamination of some atorvastatin with low levels of a nitrosamine impurity called N-nitroso-atorvastatin.

The Atorvastatin Recalls

Nitrosamines like N-nitroso-atorvastatin are considered probable carcinogens, meaning they may increase cancer risk. Although the risk from low level exposure is small, several pharmaceutical companies proactively recalled some of their atorvastatin products out of precaution.

As of January 2023, atorvastatin recalls have been issued by:

• Lupin Pharmaceuticals
• Apotex Corporation
• Amneal Pharmaceuticals
• Alembic Pharmaceuticals
• Hetero Labs Limited

The recall involves certain lots of 10mg, 20mg, 40mg, and 80mg atorvastatin tablets with expiration dates in 2023 or 2024. The FDA provides full details on the lot numbers involved in the recall on its website.

Health Risks from Nitrosamines

Nitrosamines like the N-nitroso-atorvastatin impurity are common in some foods, drinking water, and environmental pollution. Everyone is exposed to trace levels on a regular basis.

At very high doses, nitrosamines are considered probably carcinogenic. However, the FDA determined the nitrosamine levels detected in the recalled atorvastatin lots represent only a minimal risk.

The highest estimated daily nitrosamine exposure from the contaminated medication is around 1.5 times the acceptable limit. At such small excess amounts, the lifetime cancer risk is estimated to be about 1 in 44,000.

For comparison, the lifetime cancer risk from air pollution is about 1 in 2,100. So the nitrosamine risk from short-term use of the recalled atorvastatin products is quite low.

What Patients Should Do

If you currently take atorvastatin tablets, check your bottle to see if you have one of the recalled lots. If so, contact your pharmacist or healthcare provider for guidance.

They will work with your insurance plan to arrange a refill of non-recalled atorvastatin or an alternative cholesterol medication in the same class, such as simvastatin (Zocor), rosuvastatin (Crestor) or pravastatin (Pravachol).

If you have the recalled medication, stop taking it and safely dispose of it per disposal instructions. Report any health issues possibly related to the recalled atorvastatin tablets to your doctor and the FDA.

Importantly, do NOT stop taking your atorvastatin without consulting your doctor and arranging a new prescription. Suddenly discontinuing cholesterol medication can have serious health consequences.

Ongoing FDA Investigation

The FDA is continuing to test and analyze samples of recalled atorvastatin lots for the presence of nitrosamine impurities. The administration is also working with manufacturers to understand how this contamination occurred.

Preventing nitrosamine contamination during drug manufacturing is a key focus of the FDA’s overall strategy to limit impurities in common prescription medications.

While this recall understandably raises concerns for atorvastatin users, it also demonstrates that quality control systems are working to detect and respond proactively to potential medication risks.

Alternatives to Atorvastatin

If you have been advised to stop taking your atorvastatin due to the recall, talk to your doctor about alternative cholesterol treatment options. This may include:

• Other statins - Simvastatin, rosuvastatin or pravastatin are commonly prescribed alternatives.
• Non-statin drugs - Ezetimibe (Zetia), bile acid sequestrants, PCSK9 inhibitors may be used.
• Dietary changes - Improving nutrition can help lower cholesterol.
• Supplements - Fish oil, psyllium husk and oat fiber can provide benefits.

Make sure you have a new prescription before stopping the atorvastatin. Suddenly halting cholesterol medication can lead to rebound high cholesterol and increased risk of heart attack or stroke.

Maintaining Heart Health

If you do have to switch from atorvastatin to a new medication, the most important thing is continuing to properly manage your cholesterol levels. Make sure to:

• Take your new medication as prescribed.
• Follow dosage guidelines closely.
• Monitor your cholesterol with regular blood tests.
• Communicate with your doctor about any side effects.
• Adopt lifestyle changes to support heart health.

Proper cholesterol management with lifestyle and medications can reduce your risk of heart attack, stroke and other cardiovascular diseases.

The Bottom Line on the Atorvastatin Recall

The 2023 recall of some atorvastatin products due to small levels of nitrosamine contamination is understandable concerning. However, the potential health risks are very minimal. Check if your atorvastatin is one of the recalled lots. If so, safely stop taking it and work with your doctor to switch to an alternate cholesterol medication. Never stop a statin suddenly without having a new prescription in place. With sound medical advice and continued diligence managing your cholesterol levels, this atorvastatin recall should merely represent a small bump in the road on your journey to better heart health.

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.