Seldane Removed from U.S. Market over Safety Concerns


(January 5, 1998) - The Food and Drug Administration (FDA) recently requested the removal of terfenadine (SELDANE) and terfenadine plus pseudoephedrine (SELDANE- D) from the market in the United States. For those following the story, the news is not surprising. In January of 1997, the FDA recommended that the terfenadine-containing drugs be removed from the market and that physicians consider alternative medications for their patients. The reason for concern is the existence of potentially severe drug interactions with SELDANE. The interactions result in abnormalities of the electrical impulse that stimulates the heart to contract and pump blood, and the interactions could be life threatening. The interactions were first identified in 1990 and involve many drugs. Among the drugs known to interact with SELDANE are ketoconazole (NIZORAL), erythromycin (E-MYCIN), nefazodone (SERZONE), itraconazole (SPORANOX), clarithromycin (BIAXIN), mibefradil (POSICOR) as well as grapefruit juice.

In response to initial reports of serious drug interactions, the manufacturer of SELDANE embarked on a series of educational programs to physicians and patients warning about these potential hazards. Additionally, the company released another antihistamine, fexofenadine (ALLEGRA), which is a metabolite of SELDANE but which does not interact with other drugs like SELDANE. Like SELDANE, ALLEGRA does not have sedation as a side effect. In fact, since the introduction of ALLEGRA, the number of prescriptions for SELDANE has decreased by 85%.

In addition to ALLEGRA, allergy sufferers also may benefit from loratidine (CLARITIN), another non-sedating antihistamine. Moreover, many allergy sufferers benefit from one of several available intra-nasal corticosteroids, such as triamcinolone acetonide (NASACORT AQ), fluticasone propionate (FLONASE), and beclomethasone dipropionate (BECONASE AQ; VANCENASE AQ). In fact, several studies have shown that these intranasal medicines are more effective than antihistamines for relieving nasal congestion, nasal itching and sneezing associated with allergies. Thus, patients currently taking SELDANE or SELDANE-D have several alternative medications from which to choose.