Clearing Out Old Medicines

The U.S. Food and Drug Administration decided last week that eight years was long enough for its staff and its panels of expert advisers to spend cleaning out the nation's medicine chest. No fewer than 369 items, among them some of the most widely prescribed drugs, should be thrown out, said the FDA, because its investigators have determined they are not effective for their claimed purposes or are actually hazardous. The lengthy catalogue includes many items that are already being withdrawn by their manufacturers; on others, the companies are not prepared to accept FDA's judgment and they are fighting back in the courts.

In 1962 Congress gave the FDA a mandate to pass on both the safety and effectiveness of all new drugs before licensing them. Druggists' shelves then were crammed with almost 3,000 previously approved preparations. Some were gimmicky solutions supposed to sweeten the breath or whiten teeth, but others contained valuable medications. Some were made by obscure little companies, but many were produced by distinguished firms.

Doubtful Combinations. In its list of proscribed drugs, the FDA fingered major companies from Abbott and Armour through Lilly and Merck to Winthrop and Wyeth. In most cases, the products of such companies were criticized not as hazardous but as ineffective in the forms offered. This is especially true of formulations in which one drug, usually an antibiotic, is combined with one of another class, such as an antihistamine, for use against colds.

The same criticism applies to combinations of two antibiotics, or of one antibiotic with a sulfa: the FDA believes firmly that these fixed-dosage forms are likely to give a patient either too much or too little of one drug or the other. But many physicians have gone on prescribing them. The most noted example was Upjohn's Panalba (tetracycline with novobiocin), which is now off the market. Soon to follow, if FDA has its way: Squibb's Mysteclin-F (tetracycline with amphotericin B) and Roerig's Signemycin line (tetracycline with troleandeomycin).

Also under FDA attack are several drugs used against high blood pressure and blood clotting, some diuretics and products containing synthetic hormones. Among the odds and ends that the FDA wants to see no more: Winthrop's Alevaire, for asthma; CIBA's Bradosol throat lozenges; Parke-Davis' Phemerol. a skin antiseptic; and Lever Bros.' Pepsodent Antiseptic Mouthwash.

By circulating its list to federal agencies, notably the armed forces and the VA, which treat millions of patients, the FDA was certain at least to cut down sales of the proscribed items.

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