Atorvastatin Recall May Affect Hundreds of Thousands of Patients

A recently announced recall of a popular statin medication, Atorvastatin, has left many patients wondering if they'll need to switch prescriptions - and raised questions about the FDA's ability to inspect medicines made overseas.

Atorvastatin is used by hundreds of thousands of Americans to lower their cholesterol levels. The recall affects 41 lots of the medication, which was manufactured in Pakistan by a company called Zafar Medical Store (Pvt) Ltd.

• The FDA inspection that uncovered problems with Atorvastatin's manufacturing process revealed significant lapses in quality control, including inadequate testing and poor record-keeping.
• Patients taking the recalled lots of Atorvastatin may be at increased risk for cardiovascular side effects, such as heart palpitations or strokes.

The FDA has struggled to keep up with the increasing number of medications made overseas. According to a report from the Government Accountability Office (GAO), more than 90% of generic drugs used in the US are manufactured abroad, often by companies that don't meet American standards for quality and safety.

While it's unclear how long this recall will last or whether other medications will be affected, one thing is certain: the FDA needs to do a better job of inspecting medicines made overseas. In the meantime, patients taking Atorvastatin should contact their pharmacists or healthcare providers for guidance on next steps.

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