FDA clamp down on unapproved Rx drugs

The US Food and Drug Administration has announced an escalation of its clamp down on unapproved drugs, beginning with prescription products that contain the antihistamine carbinoxamine, based on safety concerns regarding their use in children under two years. A final guidance document has also been issued, which outlines the agency's approach on addressing other drugs that are sold without FDA approval.

The FDA estimates that there are "several hundred" different unapproved active ingredients in prescription drugs that are currently on sale, although this figure is believed to be less than 2% of all prescribed drugs in the USA. Acting FDA Commissioner Andre von Eschenbach, launching the new guidance document: Marketed Unapproved Drugs - Compliance Policy Guide, said: "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."

Dr von Eschenbach added: "while we want 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."