updated 6/8/2006 12:48:40 PM ET 2006-06-08T16:48:40

Manufacturers of cold, cough and allergy medicines that contain the antihistamine carbinoxamine and have not been approved have been given 30 to 90 days to stop making the products.

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In ordering this, the Food and Drug Administration said Thursday the estimated 120 such medicines that contain the antihistamine being sold today pose a safety risk to infants and young children.

Since 1983, the FDA has received reports of 21 deaths of children 2 and younger associated with the products, including those that contain carbinoxamine tannate and maleate. It isn’t clear the drug was to blame, however.

The estimated 26 manufacturers of the drugs that have not been approved must seek FDA permission if they want to continue selling the medicines. There are only two FDA-approved medicines that contain carbinoxamine, both made by Mikart Inc. of Atlanta.

The products that do not have regulatory approval include Andehist, made in drop and syrup form by Cypress Pharmaceutical Inc. of Jackson, Miss. The company will comply with the order, said a company official who refused to give his name.

A second product mentioned by FDA officials, Rondec, has not been made with carbinoxamine since December 2004, said Dr. Allen Fields, vice president of research and development at Alliant Pharmaceuticals Inc. of Atlanta.

Also Thursday, the FDA issued guidelines clarifying its stance on drugs that it has not approved, of which there several hundred are contained in several thousand different products sold today in the United States.

The guidelines underscore the FDA’s intent to deal more aggressively with the issue, said Deborah Autor, associate director of compliance policy within the agency’s Center for Drug Evaluation and Research.

Under the guidelines, the FDA encourages companies to comply with the drug approval process and seek approval for their products. It also identifies products without approval — most likely to pose a risk to public health — as the highest priority for enforcement action.

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