Warnings added to Seldane labels

FDA Consumer, Jan-Feb, 1998

People taking a new hypertension

drug or several other drugs should not

take the antihistamine Seldane or the

antihistamine/decongestant Seldane-D,

according to new warnings on Seldane's

labeling.

The hypertension drug, Posicor

(mibefradil dihydrochloride), joins

antibiotics such as erythromycin and

antifungals such as ketoconazole, which

have long been associated with severe

risks when taken with Seldane, Seldane-D,

or generic versions containing the

antihistamine terfenadine.

The new labeling also warns against

taking the antihistamine at the same

time as these drugs:

* HIV protease inhibitors such as

Crixivan (indinavir), Norvir (ritonavir),

Invirase (saquinavir), and Viracept

(nelfinavir)

* serotonin re-uptake inhibitors such as

Luvox (fluvoxamine), Zoloft (sertaline),

and Serzone (nefazodone)

* Zyflo (zileuton)

* Propulsid (cisapride)

* Zagam (sparfloxacin).

In addition, no one should take

Seldane, Seldane-D, or the generics with

grapefruit juice, and patients with

kidney difficulties should not take more

than one tablet daily.

FDA is in the process of removing all

terfenadine products from the market

because of the approval of a safer

alternative, Allegra (fexofenadine

hydrochloride). (See "Antihistamine Poses

Possible Safety Risk" in the Updates

section of the April 1997 FDA Consumer.)

Both Allegra and Seldane are

manufactured by Hoechst Marion

Roussel Inc.

FDA urges health-care providers to

report any terfenadine-related adverse

events to the manufacturer by calling

1-800-633-1610 or to FDA's MedWatch

program by calling 1-800-FDA-1088.