Seldane was an oral drug belonging to the antihistamine group of medicines. It contains Terfenadine as main active ingredient. It was a very popular drug and was introduced in the market in 1985 for treatment of allergic symptoms. It was manufactured by Hoechst Marion Roussel. The pharmaceutical company is now known as Aventis. It played as a money churner for Hoechst Marion Roussel. It churned out $440 million for its maker pharmaceutical company in 1996.

It was used to treat allergies. It was used to treat running nose, itching and watery eyes. It also prevents sneezing. Doctors prescribed it for treatment of allergic symptoms such as hives, inflammation and other allergic symptoms. It was also prescribed for purposes other than listed in medical guide by doctors based on clinical judgment. It was withdrawn from market in 1997 in U.S. due to safety concerns.

It was linked with cardiac arrhythmia. It resulted in FDA recall of this drug in 1997. It had been used by more than 100 million patients before its recall. Later Hoechst Marion Roussel came with another anti-allergy drug Allegra.

After its approval, reports of its link with cardiac arrhythmia started pouring in. these dangerous incidents were more evident when Seldane was taken with erythromycin or ketoconozole. These fatal combinations lead to high level of terfenadine in the blood, which resulted into irregular heartbeats.

Finally FDA recalled all terfenadine drugs including Seldane from the market in January 1997. Alternative drug treatments were available including Allegra from Hoechst Marion Roussel. Hoechst Marion Roussel and Baker Norton Pharmaceuticals, the manufacturer of the Seldane decided to voluntarily stop the distribution and marketing of all terfenadine drugs including Seldane from U.S. market after FDA’s decision of recall.

FDA asked physicians to consider alternative medications for treatment of their patients after recall of Seldane. It asked them to make patients aware about severe drug interactions with Seldane, which could cause fatal results. The drug interaction could lead to irregularity in electric impulses in heart. This irregularity could hinder the contraction and pumping of blood in the heart. This abnormality could yield lethal results, even death of the patient. Drugs interactions leading to these conditions are interaction of ketoconazole, erythromycin, nefazodone, itraconazole, clarithromycin, mibefradil and grapefruit juice with Seldane.

The Hoechst Marion Roussel came with another anti allergic drug Allegra, which presented alternative drug therapy for patients who were using Seldane. It does not have fatal side effects of Seldane. Other alternative drugs were also launched in the market, providing relief to the patients earlier using Seldane. FDA asked patients who were using Seldane to consult to their doctor for alternative treatment as well as to monitor harm caused to them by use of this drug.

Seldane-D was also recalled along with Seldane. It was also associated with serious and rare heart problems. It also interacted with antibiotics and anti fungal drugs to yield fatal results. Following FDA recall of these drugs, Seldane, Seldane D, and generic terfenadine drugs were discontinued from U.S. market. Their distribution and marketing were stopped by their manufacturers. Patients were asked to not use these medicines. FDA soon completed administrative procedures of withdrawal, so that all the terfenadine-containing products were permanently withdrawn from the U.S. market.