The Food and Drug Administration was asked yesterday to halt the sale of a long list of nonprescription sleep aids, nose sprays and cold medicines because they contain a chemical that has caused liver cancers in mice.
Included are drugs used by at least 10 million Americans, among them such well-advertised ones as Sominex, Compoz, Nytol COPE, Excedrin P.M., Allerest time release capsules and Vicks' Sinex.
Officials of the Environmental Defense Fund, which made the request, cited three studies conducted by the Nation Cancer Institute and Oak Ridge National Laboratory. All, they said, indicate that the chemical-an antihistamine called methapyrilene-is "a potent animal carcinogen."
The fund is a private Washington-based research group focusing on environmental issues.
EDF's Leslie Dach urged FDA "immediately" to seize methapyrilene products in interstate commerce and to call on manufacturers to start a voluntary recall pending new FDA regulations.
But FDA spokesman Wayne Pines said the agency has not completed its review of the evidence, including an interim "not final" report by a National Cancer Institute panel on the latest animal tests.
"We're awaiting the National Cancer Institute's judgment before we decide what our next step is," Pines said.
FDA last June proposed but has not yet enacted a ban on nonprescription sedatives-so-called "daytime sleep aids"-with methapyrilene, mainly because it found them without benefit and possibly harmful if they made drivers or factory workers drowsy. FDA then called methapyrilene a "possible" carcinogen or carcinogen synergist (a chemical that acts in combination with others), and said there was a need for more study.
Defenders and critics looked at the same data in different ways. The Proprietary Association, representing nonprescription drug makers, said methapyrilene causes rat tumors only "at doses equivalent in man to 200 sleep-aid tables every night for many years." The Environmental Defense Fund said anyone using such products four times monthly for 25 years would consume a quarter of the amount given half the female rats that developed tumors.
The drug association said manufacturers are "confident methapyrilene is safe at recommended doses," but will examine the evidence and act in the public interest.
Still another drug - reserpine, widely used to lower high blood pressure - has caused cancers in laboratory animals, the National Cancer Institute, part of the federal National Institutes of Health, said yesterday. NCI said studies indicate reserpine might increase human breast cancer risk by 50 to 100 percent.
FDA called a June 22 advisory group meeting to review this finding. FDA and NIH officials agreed meanwhile that the risk to life posed by untreated high blood pressure "far exceeds" the drug's potential cancer risk.
FDA said persons taking a reserpine drug should not abruptly halt its use, but could discuss possible alternatives with their doctors. Among the drugs are Demi-Regroton, Diupres, Diutensen-R, Draiserp, Exna-R, Hydromex-R, Hydropres, Hydrotensin, Metatensin, Naquival, Rau-sed, Regroton, Renese-R, Reserpine tablets, Ruhexatal with reserpine, SK-Reserpine, Salutensin, Sandril, Ser-Ap-Es, Serpasil, Serpasil-Apresoline and Serpasil-Esdrix.
Following is a list of over-the-counter sleep aids and daytime sedatives said by the EDF to contain methapyrilene (maunfacturer or distributor in parentheses):
Calm Aid capsules (Robert Daniels)
Calm capsules (Edward J. Moore)
Compoz (Jeffrey Martin Inc.)
Cope (Sterling Drug Inc.)
Dormin capsules (Dormin)
Drowze capsules (Robert Daniels)
Excedrin P.M. (Bristol-Myers Co.)
Nervine capsule shaped tablets (Miles Laboratories)
Nervine effervescent tablets (Miles Laboratories)
Nervine liquid (Miles Laboratories)
Nite Rest capsules (Amer. Pharm.)
Nytol capsules (Block Drug Co. Inc.)
Nytol tables (Block Drug Co. Inc.)
Quiet World (Whitehall Laboratories Inc.)
Relax-U-Caps (Columbia Medical)
Seedate capsules (Amer. Pharm.)
Sleep Aid capsules (Burgin-Arden)
Sleepinal (Thompson Medical Co. Inc.)
Sominex capsules (J. B. Williams Co. Inc.)
Sominex tablets (J. B. Williams Co. Inc.)
Somnicaps Amer. Pharm.)
Sure-Sleep tablets (American Labs)
Tranqium (Thompson Medical Co. Inc.)
Tranquil capsules (North American)
Allergy medicines the EDF said contain methapyrilene:
Alcear anti-allergy tablets (Walgreen)
Allercomp tablets (Wolins)
Allerest time release capsules (Pharmacraft)
Contact Nasal Mist (Menley and James)
Kleer Spray (Scrip)
Korizol nasal spray (Sutliff and Case)
Mistol Mist nasal drops (Plough)
Mistol Mist nasal spray (Plough)
S.A.C. Cold Capsules (Towne)
S.A.C. Cold Capsules w/Phenylephrine HCL (Towne)
Vicks Sinex nasal spray (regular formula) (Vicks)