Unapproved Drugs Called 'Threat'
Friday, June 9, 2006
Thousands of prescription drugs never approved by the Food and Drug Administration are on the market, and some pose clear health risks to patients, the agency said yesterday as it announced an effort to force the manufacturers either to seek approval or to stop selling their products.
The FDA focused particularly on a group of antihistamines that contain the active ingredient carbinoxamine. Agency officials said that the ingredient, which is widely used and advertised under a variety of brand names, has been linked to the deaths of more than 20 young children, although a definitive connection has not been established. Makers of the unapproved antihistamines were given 90 days to come to the agency and apply for approval.
"Right now, many unapproved drugs represent a public health threat, because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said acting FDA Commissioner Andrew C. von Eschenbach.
"While we want to ensure continued patient access to necessary treatments, as a physician I feel strongly that patients expect and deserve all their prescription medicines to be FDA-approved," he said in a statement. "These unapproved drugs have bypassed the agency approval process through which FDA ensures that marketed drugs are safe, effective, properly manufactured, and accurately labeled."
Although some unapproved products have been on the market for decades, others are relatively new, FDA officials said. The agency estimated that 2 percent of the prescription drugs now for sale have never been reviewed or formally determined to be safe and effective, as required by law.
Unapproved carbinoxamine products are often labeled for cough and cold treatment in children, the FDA said in a statement on its Web site. But the compound's safety has never been studied in young children, and the agency said there is concern that it could be harmful.
FDA officials said that the unapproved carbinoxamine medications include Histex, Rondec and Cardec. Makers of these and other unapproved drugs often advertise their products, and many are listed in the Physicians' Desk Reference, which doctors use as a guide in prescribing drugs. In documents made public yesterday, the FDA said the labels of unapproved drugs often do not mention that they were never reviewed by the agency.
There are two approved drugs containing carbinoxamine, both manufactured by Atlanta-based Mikart Inc. The two are not affected by the FDA action because they were deemed safe.
The issue of unapproved drugs has been before the FDA for years, and it had earlier focused on an anti-malaria drug, quinine sulfate. One drugmaker, Mutual Pharmaceutical Co., won approval from the agency to sell quinine sulfate as an "orphan drug" last year, but it has not yet gotten its product to the market. The president of the company wrote to the FDA last month to complain that the agency had taken "a disturbingly laissez-faire approach to the issue of the safety of unapproved quinine sulfate" sold by other companies.
Steven K. Galson, head of the FDA's Center for Drug Evaluation and Research, said the agency's more aggressive approach to unapproved drugs is part of a drug-safety initiative and "will be a significant focus for us going forward."
The FDA has come under sharp criticism for its handling of numerous drug-safety issues -- notably the sudden withdrawal in 2004 of the blockbuster painkiller Vioxx because of evidence it was causing heart problems -- and the agency has since been beefing up its safety oversight.
Galson said the agency will not go after all unapproved drugs at once, but would set priorities based on the seriousness of safety concerns and whether competing companies could provide FDA-approved versions of the medication.