WASHINGTON -- The Food and Drug Administration Friday banned more than 30 ingredients in over-the-counter hemorrhoid medications, saying they have not been proven safe and effective.
However, FDA officials said they were not ready to take final action on two anti-hemorrhoid ingredients, including a major component of Preparation H, the most widely sold product in the $150 million-a-year hemorrhoid medication market.
Dr. Sidney Wolfe of Public Citizen Health Research Group criticized the FDA's slowness in taking such steps, noting an FDA advisory panel issued its recommendations on the hemorrhoid products more than 10 years ago.
Wolfe also questioned the legality of allowing a yeast ingredient in Preparation H to be left out of the final rules. 'The live yeast cell derivative is without any evidence for effectiveness,' he said. 'The more they (the FDA) delay, the longer they (the manufacturer) can sell more of this junk.'
The regulation imposing the ban was published Friday in the Federal Register and will take effect in 12 months. Products that contain the forbidden ingredients will have to be reformulated if manufacturers want to continue to sell them.
The action is part of the FDA's massive review of the safety and effectiveness of all non-prescription drugs, which started in 1972.
Among the ingredients found to be of no proven value in relieving symptoms of hemorrhoids were: boric acid as an antiseptic, lanolin alcohols as a skin protectant and both cod liver oil and Peruvian balsam as ingredients for treating wounds.
Products that would have to be reformulated or relabeled due to the ban include: Proctofoam, made by Reed & Carnick of Piscataway, N.J.; Rectal Medicone Ointment and Suppositories, made by Medicone of New York; Pazo Ointment and Suppositories, made by Bristol-Myers Squibb Co. of New York; and Tronolane Ointment and Suppositories, made by Ross Laboratories of Columbus, Ohio, the FDA said.
Hemorrhoids are enlarged veins in the lower rectum or anus, and can cause bleeding, pain and discomfort.
Whitehall Laboratories Inc., of New York, which makes Preparation H, contends its live yeast cell derivative acts as a wound-healing agent for relief of hemorrhoidal symptoms. It has submitted results of two clinical studies to the FDA to back up its claim.
The FDA banned the other major active ingredient of Preparation H -- shark liver oil -- for use as a wound-healing agent. At concentrations much higher than the 3 percent level found in Preparation H, shark liver oil can help protect against, but not heal, hemorrhoid symptoms, the FDA added.
The second unresolved issue centers on whether to allow the steroid hydrocortisone to be used in combination with other non-prescription ingredients, including the topical anesthetic pramoxine. No over-the-counter hemorrhoid products with these combinations currently exist, but some manufacturers wish to produce them.
The FDA concluded 33 other ingredients were safe and effective for protecting the skin, reducing swelling or relieving discomfort, itching and inflammation associated with hemorrhoids.
'It should be reassuring to consumers that at least one of these ingredients is present in virtually every major non-prescription rectal product sold,' said William Gilbertson, director of FDA's Division of Over-the-Counter Drug Evaluation.
Most of the approved ingredients are for use externally on skin, while some may also be used on mucous membranes just inside the rectum.
No ingredients to relieve pain, soreness and burning were approved for internal use because there are no known nerve endings inside the rectum, the FDA said. Products that currently contain such ingredients will either have to be reformulated or be relabeled 'for external use only.'