NEW YORK, Dec 28 (Reuters Health) -- Labels on bottles of mineral oil should include a warning of a risk of a serious lung disease in some patients, according to a letter published in the December 24th issue of The New England Journal of Medicine.
Taken as a laxative at bedtime, mineral oil can cause a lung disease called "lipoid pneumonia" in children or the bedridden when the oil is regurgitated and inhaled into the lungs.
In the letter, Dr. David E. Langdon of Arlington, Texas, writes that he recently read mineral oil bottles in pharmacies and supermarkets.
Langdon noted that none of the labels he inspected "displayed any warnings indicating the population at particular risk from such bedtime use: persons with nocturnal reflux."
"Should not persons with known hiatus hernias and symptomatic reflux be warned to avoid using these products just before recumbency?" the physician asks.
In a written reply published in the journal, Dr. Debra L. Bowen from the Food and Drug Administration (FDA) notes that the agency "requires manufacturers to label orally administered mineral-oil products as not for use in infants, and to warn against their use in young children or bedridden persons."
But Bowen also writes that "the directions and warnings sections of labels of mineral-oil containing laxatives can be strengthened in order to enhance their safe and effective use." Further, she states that the FDA plans to publish "a final rule" concerning laxatives that "will include required labeling improvements."
SOURCE: The New England Journal of Medicine 1998;339:1947-1948.
