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 Thursday, 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 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 definite connection has not been established. Makers of the unapproved antihistamines were given 90 days to apply for FDA 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 von Eschenbach.
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 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 the unapproved carbinoxamine medicines 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 Thursday, the FDA said the labels of unapproved drugs often do not mention that they were never reviewed by the agency.
Two approved drugs contain carbinoxamine, both manufactured by Mikart Inc. The two are not affected by the FDA action.
The agency has been sharply criticized for its handling of numerous drug-safety issues -- notably the sudden withdrawal in 2004 of the blockbuster painkiller Viol because of evidence it was causing heart problems -- and the agency has since been beefing up its safety oversight.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
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