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Caution: Dulcolax name extensions

From the April 8, 2004 issue

Gastroenterologists, office staff, nurses, and pharmacists may be unaware that there are several over-the-counter (OTC) products using the brand name DULCOLAX. For example, one has bisacodyl, a laxative, as its main ingredient while another contains docusate sodium, a stool softener (photo appears in the PDF version of the newsletter). Recently, a patient needing a colonoscopy was handed printed instructions by his physician's office staff that called for a bottle of magnesium citrate and two tablets of "Dulcolax" each day for 2 days before the colonoscopy. Although bisacodyl is needed for the bowel prep, only the brand name Dulcolax appeared in the printed instructions. Later, at the drugstore, the patient was directed to the laxative aisle where he purchased the Dulcolax stool softener. On the first day, he took two Dulcolax, but on the second day, his son, a pharmacist, recognized that his father was taking the stool softener (docusate sodium), not the laxative. The patient's son later drove to the drugstore to purchase bisacodyl and found the two Dulcolax products side-by-side. His father completed the bowel prep properly and successfully underwent the colonoscopy. Please notify gastroenterologists and associated office staff about this problem. Ask them to warn patients about possible confusion between these Dulcolax products and emphasize, in oral and printed instructions, that only bisacodyl should be used for the bowel prep. It's possible that, in the past, practitioners have simply assumed that patients weren't compliant with bowel preps when, in reality, they were using the wrong substance! We've often written about safety issues when the same brand name is used for products with different ingredients. Unfortunately, a loophole in the Code of Federal Regulations (CFR) allows companies to market designated OTC products without specific approval of the product names by FDA. A new drug application (NDA) or abbreviated new drug application (ANDA) does not have to be filed for designated monograph drugs in the CFR. Without FDA's review, companies can capitalize on a well-known, trusted, brand name and use it for any product, including an entire line of OTC products with different ingredients. There are at least 7 products that carry the Dulcolax brand name ( Marketing considerations sometime trump safety considerations and, unless harm is well documented, FDA can do nothing to require a name change. As previously stated, brand name extensions for OTC products should not be allowed unless at least one ingredient from the original product is present in the new or modified product. This incident offers more evidence that the regulations should be changed to provide FDA with the opportunity to assure drug name safety for OTC products.

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