Recalls call into question metoprolol generics

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Recalls call into question metoprolol generics

Genéricos/General | Posted 08/08/2014 0 Post your comment

Recent recalls have vindicated a cardiologist’s warnings about generic versions of a widely used heart drug, Toprol XL (metoprolol).

Toprol XL (metoprolol) is a beta-blocker used to treat angina (narrowed arteries) and high blood pressure.

Dr Harry Lever, a cardiologist at the Cleveland Clinic in the US, wrote a letter outlining his concerns to the US Food and Drug Administration (FDA) in 2012 after he noticed that patients complained of chest pains after switching to a generic version of metoprolol. Then in 2014, he also went to Washington to try to get the attention of Congress. This is not the first complaint about metoprolol generics; FDA has already received thousands of complaints from doctors and patients [1].

In May 2014, FDA first recalled more than 13,000 bottles of metoprolol extended release tablets manufactured by Indian generics maker Dr Reddy’s Laboratories. This was followed by a recall of more than 100,000 bottles of generic metoprolol from India-based generics maker Wockhardt.

The generics were recalled due to the failure of dissolution tests and were categorized as Class II, which FDA states ‘may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote’.

Although Dr Lever admits that his evidence is ‘anecdotal’ and not scientific, he says that he often observed problems when switching to generics made in India. A fact that he feels is ‘sadly vindicated’ by the recent recalls.

The Indian generics makers had to recall their products as they were not dissolving properly therefore probably not working as they should.

These latest recalls will only add to calls for stricter and wider testing of generics entering the US. FDA has already allocated US$20 million for testing generics and has been assessing generics since September 2013 [2]. The agency is also already planning an extensive study of blood-pressure drugs, which includes generics of AstraZeneca’s extended release Toprol XL (metoprolol). Generics produced by US-based generics makers Actavis and Mylan, as well as India-based generics makers Dr Reddy’s Laboratories and Wockhardt will be included in the study [1].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Blood-pressure generics to be included in FDA’s testing plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Generics/News/Blood-pressure-generics-to-be-included-in-FDA-s-testing-plans
2. GaBI Online - Generics and Biosimilars Initiative. FDA starts widespread testing of generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Generics/General/FDA-starts-widespread-testing-of-generics

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Source: FDA