What's the common bond between cantharides, ginseng, Pega Palo, yohimbine, diluted hydrochloric acid, jojoba oil, wheat germ oil, mustard oil, and spirits of turpentine? They're all ingredients that shouldn't be in some over-the-counter (OTC) drugs, according to FDA.
These, plus a host of other acceptable, questionable and unacceptable ingredients were included in a series of proposed rules to establish standards for nine categories of OTC drugs.
The proposed rules, published in the Jan. 15, 1985, Federal Register, were based on FDAhs review of the recommendations of several expert advisory panels. The proposals are part of the agency's massive evaluation of OTC drug ingredients and labeling. Final rules will be developed following a review of public comments on the proposals.
For the most part, FDA agreed with the panels' recommendations, although there were some significant differences. Following are highlights of these proposed rules.
Topical Acne Drug Products: A major change FDA made in the list of acceptable ingredients was the addition of salicylic acid 0.5 percent to 2 percent. The expert advisory panel had said it needed additional study. FDA made the change based on new data that were submitted to establish safety and effectiveness.
Concentrations of salicylic acid greater than 2 percent up to 5 percent would still need further study to establish their safety and effectiveness.
The range of concentrations of sulfur-resorcinol combinations also was broadened in FDA's proposal.
These are the OTC ingredients FDA said were safe and effective for the treatment of acne:
* benzoyl peroxide
* salicylic acid
* resorcinol and resorcinol monoacetate in combination with sulfur.
As to acne product labeling, FDA proposed dropping terms such as "lesion" or "follicle" because consumers would not understand them. Also dropped from the panel recommendations are phrases such as "loosens blackheads," "unclogs pores to help clear acne," or "reduces blackheads." Instead, the agency prefers "clears up," "clears up most," or "reduces the number of" blackheads, acne pimples, or acne blemishes.
Manufacturers may also choose appropriate labeling terminology to complete the phrase "penetrates pores to " ("eliminate most," "control," "clear most" or "reduce the number of") "blackheads" or "acne pimples."
Regarding the use of acne medications, FDA proposed a waarning statement that reads, "Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor."
For additional information, see the following articles in FDA Consumer: "Stubborn And Vexing, That's Acne," May 1980 (also available as a reprint) and "Hope For Acne Victims," June 1982.
Antihistamines: FDA's proposed ingredient list for OTC antihistamines includes the addition of three antihistamines currently available by prescription only: dexbrompheniramine maleate, dexchlorpheniramine maleate, and triprolidine hydrochloride. These ingredients were not reviewed by the advisory panel.
Dropped from the list were methapyrilene hydrochloride and methapyrilene fumarate, taken off the market in 1979 after studies showed they caused cancer in laboratory animals. Promethazine hydrochloride was placed in the category that calls for additional study before this drug can be switched from prescription to OTC status.
The 10 antihistamines FDA regards as safe and effective for OTC use are:
* brompheniramine maleate
* chlorpheniramine maleate
* dexbrompheniramine maleate
* dexchlorpheniramine maleate
* diphenhydramine hydrochloride
* phenindamine tartrate
* pheniramine maleate
* pyrilamine maleate
* thonzylamine hydrochloride
* triprolidine hydrochloride
As for the labeling, FDA proposed including the use of antihistamines for the temporary relief of the runny nose and sneezing associated with the common cold, in addition to allergic rhinitis (hay fever). However, people with asthma are being advised not to take antihistamines unless directed by a doctor. FDA is also warning against the use of these drugs in patients with any obstructive pulmonary disease in which clearance of secretions is a problem.
In the preamble to the original report of the advisory panel on cough, cold, allergy, bronchodilator, and anti-asthmatic drug products (sometimes called the cough-cold panel), FDA disagreed with the classification of diphenhydramine hydrochloride as safe and effective for OTC use, in part because of the risk of excessive drowsiness. Now the agency has found that this does not justify restricting a drug to prescription use if the label contains adequate warnings and the drug is packaged in child-resistant containers. Thus, labels for diphenhydramine must include the warning "may cause marked drowsiness." The modifier "marked" is not required on the labels for other OTC antihistamine drugs.
FDA agrees with the panel's recommendation to increase the currently available OTC dosage of chlorpheniramine maleate from 2 milligrams to 4 milligrams every four to six hours, with a maximum daily dose of 24 milligrams.
Nasal Decongestants: One ingredient--1-desoxyephedrine--was moved into the safe and effective category in FDA's proposed rule for nasal decongestants. Other safe and effective ingredients:
* ephedrine (topical)
* ephedrine hydrochloride
* ephedrine sulfate
* racephredrine hydrochloride
* naphazoline hydrochloride
* oxymetazoline hydrochloride
* phenylephrine hydrochloride (oral)
* phenylephrine hydrochloride (topical)
* pseudoephedrine hydrochloride (oral)
* pseudoephedrine sulfate (oral)
* xylometazoline hydrochloride
(Mustard and turpentine oils are among those ingredients not in the safe and effective category.)
FDA deferred a decision on the status of phenylpropanolamine (PPA) in nasal decongestant and weight-reducing drug products until a later date.
The agency considers oxymetazoline hydrochloride and xylometazoline hydrochloride too potent for use in young children, unless directed by a doctor. Therefore, dosage recommendations for children under 6 were deleted from the labeling.
Indications for nasal decongestants are expanded in FDA's proposal to include the claim "relieves sinus pressure," and warnings for oral nasal decongestants are expanded to read, "Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor."
For more FDA Consumer reports on the cough-cold panel, see: "The Common Cold, Relief But No Cure," September 1976 (also available in reprint form); "Drug Standards Offered," October 1982; "Help For Wheezers," February 1983; and "Cough Syrups May Switch," February 1984.
Poison Treatment Drug Products: Ipecac syrup was the only active emetic ingredient (a substance that causes vomiting), and activated charcoal was the only adsorbent ingredient recommended as safe and effective by two advisory panels. FDA has incorporated these recommendations into a single proposed rule for poison treatment drug products.
Poison treatment products may be sold separately or in a kit containing one 30-milliliter container of ipecac syrup and a minimum of one 20-gram dose of activated charcoal. The proposed rule-making calls for a two-part label. The principal display panel tells whom to call for help ("a poison control center, emergency medical facility, or health professional") and where on the package to find full warnings and directions for use. Space is to be provided on the label for writing in local emergency phone numbers.
FDA is concerned that the labeling be easily and rapidly understood by consumers because the products would most likely be used in an emergency situation. Generally, the use of activated charcoal should be restricted to administration following the induction of vomiting. There are situations in which activated charcoal can be administered without inducing vomiting, but this decision should be made by a health professional on an individual case basis.
Hair Grower and Hair-loss Prevention Drugs: FDA agrees with the adivsory panel that no current OTC product is effective for growing hair or preventing hair loss. Thus, the agency proposes to remove such products from the market after the final rule is published. Manufacturers who want to market a product for hair loss would have to prove its claims to FDA before the product could go on the market.
Among the ingredients in lotions, creams and other OTC products touted as hair growers are amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and other B vitamins, hormones, jojoba oil, lanolin, polysorbate 20 and 660, sulfanilamide, tetracaine hydrochloride, urea, and wheat germ oil. FDA will ban all of these.
Additional information can be found in "Balding IS Forever," FDA Consumer, February 1981 (also available in reprint form).
Aphrodisiacs: Drugs promoted as aphrodisiacs will suffer the same fate as baldness drugs. Ingredients currently promoted for this purpose will be taken off the market when a final rule is published, and new products will need FDA approval for marketing.
The agency said some of the ingredients reviewed, such as testosterone and methyltestosterone, are too powerful for OTC use. Some alleged aphrodisiacs, such as cantharides (Spanish fly), pose serious health risks. For a host of others, there is no scientific evidence they are safe and effective. This includes such esoteric substances as ginseng, golden seal, gotu kola, nux vomica, Pega Palo, yohimbine, and the deadly strychnine.
Individuals suffering from decreased libido and impaired sexual performance should seek professional medical care or counseling.
Hypophosphatemia and Hyperphosphatemia: These are conditions in which there is an abnormally low or abnormally high level of phosphate in the blood. Because neither condition is amenable to self-treatment, FDA has proposed removing from the OTC market any product that claims to be a treatment for these conditions.
The two ingredients reviewed by the panel were aluminum phosphate and aluminum carbonate, which also are ingredients in antacids. FDA has proposed changes in the professional labeling of antacids to include a warning that aluminum phosphate can harm kidney patients receiving dialysis.
Stomach Acidifiers: FDA has proposed taking off the market any OTC drug products that claim to be effective in treating achlorhydria and hypochlorhydria (absence or deficiency of hydrochloric acid in gastric juice) because such conditions have no clearly defined symptoms.
Acidifiers reviewed and rejected as unsuitable for OTC use were betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin.
Laxatives: Some 50 ingredients and combinations of ingredients were deemed safe and effective by the advisory panel on laxatives, and FDA agreed with this classification. These ingredients are grouped according to the way in which they do their job. For instance, bran and methylcellulose are acceptable bulk-forming laxatives; glycerin and sorbitol are hyperosmotic laxatives; castor oil and danthron stimulate the bowels; while magnesium hydrochloride and sodium phosphate are classed as saline laxatives.
An article in next month's FDA Consumer will discuss the proposed rule on over-the-counter laxatives, their use and misuse, in greater detail.
COPYRIGHT 1985 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group