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Industry, FDA spar on names for drugs

Mix-ups pose a safety threat, advocates say

By Anna Edney
Bloomberg News / August 16, 2011

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WASHINGTON - The pharmaceutical industry wants US regulators to lose their power to change proposed drug names that may be confused with other medications, unless the agency streamlines its procedures.

Pharmaceutical Research and Manufacturers of America, a drug industry lobbying group, told the Food and Drug Administration that name reviews should be overhauled or repealed “because there are no validated measures or processes to define or determine when two proprietary names are similar.’’ The comments were made in response to a government request for input.

Drug-name mix-ups have involved companies including Johnson & Johnson and GlaxoSmithKline PLC. The Institute for Safe Medication Practices, a nonprofit watchdog group, said they are among the most common causes of medication errors. The group maintains a list of almost 800 confused-name pairs, most published more than a decade ago, president Michael Cohen wrote in a post on Philly.com.

“The FDA name-testing program provides a crucial safety benefit,’’ wrote Cohen. “Without this set of eyes, there is little doubt that the number of serious errors could be far greater.’’

PhRMA agrees with Cohen that industry and other stakeholders should meet with the FDA to improve the process, said Jeffrey Francer, the group’s assistant general counsel.

Those parties should determine how often name confusion contributes to medical errors and make the agency’s review process quicker and more transparent, Francer said.

The FDA said in June that J&J and Glaxo should revise packaging for drugs that have similar names after mix-ups sent at least five patients to the hospital for taking the wrong medication.

The agency warned of confusion between Risperdal, an antipsychotic made by J&J, and Requip, a medicine for Parkinson’s disease and restless-leg disorder made by Glaxo.

The agency also asked Takeda Pharmaceuticals Co. to rename its heartburn medication Kapidex in March 2010 after name confusion with the chemotherapy drug Casodex, made by AstraZeneca PLC and a pain medication. Takeda’s Kapidex is now Dexilant.