What’s In A Name? Maybe A Serious Side Effect

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hello-3Three years ago, Johnson & Johnson changed the name of its Alzheimer’s drug Reminyl after it was confused with a diabetes med, Amaryl. Mix-ups were linked to two deaths and serious health problems. Changing the name of a drug already on the market is unusual, but the case highlights a growing dilemma that similar names can lead to medication errors, The Star-Ledger of New Jersey reports.

“This is a very urgent problem,” Diane Cousins of US Pharmacopeia, the official standard-setting authority for prescription and over-the-counter meds, tells the paper. “What we have seen is that the number of reports of similar-named drugs is increasing, and the number of different products implicated in medication errors is increasing.”

The FDA, under a congressional mandate, is now preparing a pilot project aimed at changing the way it reviews and approves drug names in hopes of improving safety and streamlining the process. The agency rejects 35 percent to 40 percent of the names initially proposed by drugmakers, but even with the current level of scrutiny, data show the system is badly flawed, the paper reports.

According to US Pharmacopeia, a nonprofit public-health organization, nearly 1,500 brand-name and generic drugs have been implicated in med errors because their names looked or sounded like some other drug. The organization recently compiled 3,170 pairs of drug names that have close similarities, nearly double the number from its previous survey in 2004.

A 2006 study by the Institute of Medicine, a branch of the National Academy of Sciences, found medication errors injure 1.5 million people annually, and it attributed 25 percent of all errors to confusion caused by similar drug names.

Under current regs, drugmakers submit proposed names, often with marketing in mind, and the FDA conducts an independent review as part of the drug-approval process. A small FDA staff examines whether a drug sounds, looks or is spelled like another medication. It also tries to determine if the name overstates the drug’s effectiveness, minimizes its risks, broadens its indications, implies unsubstantiated superiority to other medications or is simply too fanciful.

The pilot project now under way will shift the initial burden from the FDA to the drugmakers, which would have to submit a detailed analysis and data on their proprietary name proposals for the agency to review, rather than have the FDA do its own research.

Susan Proulx, president of Med-E.R.R.S., a firm that helps drugmakers evaluate names, packages and labels to minimize medication errors, says she is “happy to see the FDA moving forward. Time will tell. We are all looking forward to working with the FDA and the pharmaceutical companies to develop the best methods to reduce medication errors. No one wants medication errors to occur.”

Proulx said her organization and others do name tests for drugmakers to determine if there is a risk of confusion, and engage in pre-market testing with doctors and pharmacists based on spelling, pronunciation, writing samples and other indicators.

“There are only 26 letters in the alphabet, and the chance of a name being incorrectly pronounced or written or confused for another product is high,” Proulx says, adding that drugmakers generally start with hundreds of names, do trademark and marketing reviews, then whittle them down before picking one.

The drug most commonly confused with others during a recent three-year period, according to US Pharmacopeia, was Cefazolin, an antibiotic. The organization found it has been confused with 15 other drugs, most of them antimicrobials. Similar names include Cephalexin, Ceftriaxone, Cefoxtin and Cefotaxime.

Other drugs on the watch list include Navane, an antipsychotic medicine, and Norvasc, a hypertension drug; Cisplatin and Carboplatin, both oncology drugs; Celexa, an antidepressant, and Cerebyx, a seizure drug; and Lamictal, an epilepsy medication, and Lamisil, a drug for fungus infections.

Jerry Phillips of the Drug Safety Institute, a company that helps develop drug and health care product brand names, says pharma strives to get a name that is “memorable” while also passing trademark and legal clearances in the US, Europe and Canada.

And Phillips, a former FDA official who worked on labeling and naming issues, adds some drugmakers do a through job of avoiding look-alike and sound-alike names, while others do not. For this reason, he hopes the FDA pilot program will provide better guidance and standards, and “lead to a more consistent approach and a lower rejection rate.”

“I don’t think the FDA is admitting it has a flawed process, but the industry probably could do it better, and that’s the reason to turn over more responsibility to the drugmakers,” he says.

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  1. This issue seems to pop up again every few years. It will be interesting to see if e-Rx makes this problem all but go away.

  2. A couple of years ago the FDA issued a consumer alert entitled:

    http://www.fda.gov/oc/opacom/reports/confusingnames.html

    FDA Public Health Advisory
    January 2006
    Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names

    While it’s stated target audience was US travelers going abroad, the notice might also be construed as part of the rationale against. allowing drug imports. I happened across it as a resource in my work as a medical interpreter.

    The take away message is that it is important to know about drugs with same or similar names that may have very different active ingredients, and that global naming issues also be addressed to benefit patients.

  3. My name is Daniel Wilson and i would like to show you my personal experience with Celexa.

    I am 27 years old. I took this drug on and off for 3 years (2 years on, 1 off). It definetely helped my anxiety. The major side effect was the weight gain. Trying the new version (Lexapro) now. I’m hoping it will have better side effects.

    I have experienced some of these side effects-
    Weight Gain, diarrhea.

    I hope this information will be useful to others,
    Daniel Wilson

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