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Dec 26, 2006 11:26 pm US/Central
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Are Drugs Not Approved By The FDA Safe?
by Dennis Douda
(WCCO)
We go to the doctor, get a prescription and assume it is safe, but each year, physicians and pharmacists unknowingly give patients drugs that don't have the government's OK.
Oxycodone hydrochloride, Phenobarbital and chloral hydrate are popular medications prescribed by doctors and doled out by pharmacists. None of them are approved by the U.S. Food and Drug Administration.
"Tackling the problem of unapproved drugs is a high priority for the agency right now," said Deborah Autor, associate director of the FDA Office of Compliance.
In fact, an estimated 65 million prescriptions are handed out for unapproved drugs each year. They're most commonly cough and cold medications, sedatives, and single ingredient narcotics. Some have been on the market for years, since before the current FDA approval system.
According to Autor, others "are on the market simply because the manufacturers have chosen not to get FDA approval, even though they were required to do so."
Excepting a few isolated cases, that makes them illegal.
Dr. Kenneth Kaitin, a drug development expert at Tufts University, is concerned unapproved drugs don't go through proper channels. He said the government mandates rigorous testing and strict safety standards for a reason.
"This is the way we assure that the drug supply available to consumers in the United States is relatively safe and effective," he said.
Sheila Elias regularly takes medication and is now worried that some may not have not gone through the approval process.
"I thought the FDA had to approve every drug on the market," she said. "It does concern me."
She is not alone. The medical community shares her concerns.
"Most pharmacists that you talk to would be very surprised to hear that not all prescription products are approved by the FDA," said Dr. Mark Lutz, a drug information specialist.
The explanation for this may be because they're marketed and sold along with approved drugs. They arrive from the manufacturers with national drug codes and say "prescription only."
Some companies even pay to have their unapproved drugs listed in the Physician's Desk Reference, which is used by virtually every doctor.
In response, the American Medical Association said the government must start enforcing its safety standards.
"If a company is not following those rules, then they should not have the right to put medications on the market which would pose possibly unacceptable risks," said Ronald Davis,
president-elect of the AMA.
The FDA is now cracking down. It wants all drugs either approved or off the market.
"We have taken action against a number of companies," said Autor. "We are using enforcement against companies and drugs that lack that approval."
While there are concerns, experts say "unapproved" doesn't always equal "dangerous." As an example, the FDA pointed to Phenobarbital, which the agency admits is useful to control seizures.
According to Davis, patients who find out their prescription isn't approved "should continue taking it until they have a chance, hopefully in the very near future, to talk to their doctor."
"They can advise you about whether you should continue taking that drug," said Autor. "In some cases, an unapproved drug may be better than the alternatives."
Elias did some checking and found all her prescriptions have been FDA-approved, but she said she'll keep an eye on the status of all her medications in the future.
"I think that I would feel more comfortable," she said.
WCCO-TV contacted several drug makers selling unapproved drugs. Only one called back to inform us the company didn't want to talk about it. The Branded Pharmaceutical Association represents many of those drug makers. That group didn't call us back either.
(© MMVI, CBS Broadcasting Inc. All Rights Reserved.)