Why Did Toporal Beta Blocker Get Recalled?
Toprol XL is a brand name for metoprolol succinate extended release (ER) tablets, a beta blocker that is used to treat angina (chest pain), hypertension (high blood pressure), abnormal heart rhythms and other heart problems. Toprol XL has not been recalled. However, two companies that manufacture a generic formulation of metoprolol succinate ER tablets, Sandoz Inc. and ETHEX Corp., have issued recalls.
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Sandoz
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In August 2008, the U.S. Food and Drug Administration (FDA) issued a warning letter to Sandoz Inc. regarding its failure to comply with certain government procedures when manufacturing its generic metoprolol succinate ER tablets. The main issue involved how the pills dissolve.
Consumer Complaints
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In March 2008, ConsumerLab.com issued a report on complaints of increased blood pressure and heart rate from some consumers who were taking Sandoz' generic metoprolol succinate ER tablets. Some consumers also reported side effects, including nausea, dizziness and headaches, when switched from Toprol XL to Sandoz's generic formulation.
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Sandoz Recall
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In November 2008, Sandoz issued a voluntary recall of all metoprolol succinate ER tablets distributed to retail outlets between approximately November 2006 and October 2008. These lots had expiration dates through August 2010.
ETHEX Recall
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In January 2009, ETHEX issued a voluntary recall of more than 60 generic drugs it produces, including metoprolol succinate ER tablets. A major cause for the recall was production of some oversized tablets that were delivering higher doses of medication than specified on the product labels. In February 2010, operations at ETHEX were scheduled to be shut down.
Shortages
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As a result of these two recalls, some areas experienced shortages of generic metoprolol succinate ER tablets. In an attempt to alleviate these shortages, AstraZeneca, who manufacturers Toprol XL, instituted measures to ensure that its branded metoprolol succinate ER tablets were fairly distributed. These restrictions were lifted in May 2009 as AstraZeneca claimed it was now able to manufacture and distribute enough Toprol XL, along with an approved generic formulation of metropolol succinate that it comarkets with Par Pharmaceuticals, to meet the high demand for this product.
Your Rx
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If you are uncertain as to whether your metoprolol succinate ER tablets were affected by the two product recalls, you should either contact your pharmacist or the doctor who wrote your prescription.
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References
- US Food and Drug Administration Warning Letter to Sandoz Inc.
- Heart Failure Chat: Warning! Metroprolol Succinate ER
- Drug Injury Watch: Sandoz Metroprolol Succinate ER Tablets Recall Has Been Done Rather Quietly
- Drug Watch Injury: ETHEX Corp Issues Voluntry Recall Of All Pills
- Toprol-XL availability update
Resources
- Photo Credit pills image by Zbigniew Nowak from Fotolia.com
