The U.S. Food and Drug Administration has a reputation as one of the strictest regulators in the world. But in many ways, that distinction is undeserved, a leading pharmaceutical expert tells Newsmax Health.
“Just listen to TV commercials about prescription drugs. They sound like horror stories. You want to shudder at the list of warnings that often include risk of death,” says Joe Graedon, one of the nation’s top pharmacologists and host of the The People’s Pharmacy radio show and co-author of a popular newspaper column.
The FDA has approved a number of drugs that are banned in other countries because of evidence they are ineffective and/or risky.
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In fact, the FDA is considerably more lax in its oversight than drug regulators in Europe and other parts of the world, according to a 2012 study at the Temple University School of Pharmacy.
Temple researchers speculated the U.S. agency is influenced by the financial clout wielded by big pharmaceutical companies.
Here are five prescription drugs that Americans take that are banned in other countries:
This diabetes medication has been associated with a 64 percent increased risk of heart failure over a 7-year period. The drug has also been linked to a 27 percent increase in strokes and a 43 percent increase in heart attacks.
Avandia, the trade name for rosiglitazone, was withdrawn from the UK and India in 2010 following recommendations by the European Medicines Agency because of heart risks. It was withdrawn in New Zealand and South Africa in 2011.
This is another risky diabetes drug banned outside the U.S., says Graedon, an adjunct professor at the University of North Carolina Eshelman School of Pharmacy.
“This drug has been associated with increased risk of bladder cancer,” he says. “But even though the FDA itself issued a warning about the cancer risk, it’s still a best seller.”
Actos is banned in France and Germany.
“I ask my patients on Actos to consider dropping it and give them an alternative,” says Dr. Albert Levy of Icahn School of Medicine at Mount Sinai.
This muscle relaxant, generically known as carisoprodol, “is potentially fatal because it acts on the central nervous system much like alcohol and is highly addictive,” Graedon said.
“Instead of Soma, most physicians now prescribe benzodiazepines like Valium or Xanax for anxiety and more specific muscle relaxers that target the painful area.”
Norway and Sweden have pulled the drug off the market because of problems with dependence and intolerable side effects.
This stimulant was one half of the main ingredients in the notorious diet pill “fen-phen” that was taken off the market by the FDA in 1997 due to heart valve problems in patients. While its sidekick fenfluramine was banned in the U.S., phentermine remains legal and is still a popular diet aid.
It has been banned in the UK and elsewhere because of heart risks.
This group of central nervous system depressants is used to treat insomnia and anxiety disorders. They include phenobarbital, amobarbital, pentobarbital, and hexobarbital. These drugs have been banned overseas because of fatal intoxication and abuse potential.
“The FDA continues to drop the ball as a regulating agency when it comes to keeping Americans safe,” says Graedon. “These drugs simply should not be on the U.S market.”
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