NEW YORK, Feb 10 (Reuters) -- 'Inactive' fillers, dyes, and flavorings in common drugs may be causing adverse reactions, and should be clearly marked on ingredient lists, experts say.
"The voluntary system (for ingredient disclosure) is clearly inadequate," says a new report from the American Academy of Pediatrics (AAP). "Again, the AAP recommends mandatory labeling for all prescription and over-the-counter drugs."
Additives -- often used as fillers, sweeteners, and dyes -- "frequently make up the majority of the mass or volume of oral and (non-oral) drug products," according to the AAP. There are over 773 such additives already approved for use in medications by the Food and Drug Administration (FDA). Researchers say most are "considered to be inert and do not add to or affect the intended action" of the drug itself.
But the AAP had real concerns about eight major drug additives:
-- Sulfites, antioxidants found in many anti-asthma drugs, have been known to induce "serious reactions" such as wheezing, breathing difficulties and chest tightening in asthmatic children. Sulfites are also found in some anti-inflammatories, antibiotics, and the anti-allergy drug epinephrine.
-- Benzalkonium chloride, a preservative found in asthma inhalers and some nasal decongestants, can, itself, induce constriction of the bronchial airways in a small percentage of asthmatics. Although AAP experts say "a single dose is unlikely to cause a reaction," they recommend that the compound not be included in drugs used to treat those with severely compromised lung function.
-- Sweeteners such as aspartame (commonly found in diet soft drinks), and saccharine are also used as drug additives, especially in those aimed at children. Headaches are the most common side effect of aspartame, researchers say, adding that "up to 11% of patients with chronic migraine headaches reported headaches triggered by aspartame." The sweetener has also been linked to hallucinations, panic attacks, dizziness, and mood swings in rare cases. Saccharin is not recommend for children with "sulfa" allergies, and has been linked to short-term problems with infant muscle tone, 'lazy' eye, irritability, and insomnia.
-- Benzyl alcohol, another preservative, has been linked to "a number of neonatal deaths and severe respiratory and metabolic complications in low-birth-weight premature infants." Most drugs have very low levels of benzyl alcohol and are not suspected of causing infant complications, although the AAP note that "the effects of lower amounts... have not been adequately studied."
-- Dyes are used in almost every medication, with varying effects. For example, the yellow dye tartrazine is harmful in a minority (2.4%) of those already allergic to aspirin. Another dye, 'sunset yellow' has been associated with gastric upset. The suspected carcinogenic effects of the dye erythrosine has sparked its removal from all topical products and most oral drugs.
-- Lactose, or milk sugar, is known to affect lactose-intolerant individuals, causing diarrhea, dehydration, and cramping. It's often used as a filler in capsules and tablets.
-- Propylene glycol, an ingredient used to make drugs more soluble, can bring on respiratory problems, irregular heartbeat, low blood pressure, and seizures in rare cases. Skin rashes have occurred in 4.5% of 487 patients in one study on detecting sensitivity to propylene glycol.
The AAP point out the "increasing number of reports of adverse reactions" associated with drug additives, and say they stand by an earlier statement urging "the FDA mandate labeling of over-the-counter and prescription formulations to include a... list of inactive ingredients."
SOURCE: Pediatrics (1997;99(2):268-278)
