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Sharon Kirkey said:... Dudley had no idea that the drug she was taking for nerve pain, gabapentin, had been approved in Canada only for epilepsy, and not for pain. Nor could she know that six years later - this past month - the U.S. Food and Drug Administration would announce it will require the makers of gabapentin and other anti-epileptics to warn that their use increases the risk of suicidal thoughts and behaviour.
The drugs are among the most heavily prescribed for "off-label" uses, meaning for conditions for which they have never been approved.
Thousands of times a day in Canada, patients are prescribed drugs off-label. The practice is burgeoning, it is legal and most of it occurs with little to no scientific backing.
Of the 423 million prescriptions filled by drugstores across Canada last year, an estimated one quarter - 89 million prescriptions - were written off-label.
Prozac is being used for obesity. Metformin, a diabetes drug, and topiramate, an anticonvulsant, are also being prescribed for weight loss.
Some of the most widely prescribed drugs for insomnia, including antidepressants and antipsychotics, have never been approved for sleep problems.
People with lower back pain are being treated with drugs approved only for major depressive disorder. Heart drugs are being used to treat cluster headaches.
Critics say that off-label drug prescribing can amount to an uncontrolled experiment, and that not only do most patients not know when a drug is being prescribed for a condition for which it has not been approved, neither do most doctors.
In Canada, the only approved use for gabapentin, the drug Susan Dudley was prescribed, is for patients with epilepsy whose seizures aren't controlled by conventional therapy. But nearly 1.7 million prescriptions were filled for the drug last year alone, according to IMS Health Canada, making it the second most prescribed drug in its class.
Doctors have prescribed gabapentin (marketed under the brand name Neurontin) for bipolar mood disorders, panic disorders, insomnia, migraines, social phobia, hot flashes in post-menopausal women, attention deficit disorder and "for all kinds of pain that it has never, ever been shown to be effective for," says Dr. David Wilkes, a professor of medicine at the University of California Davis.
In January 2008, the American Food and Drug Administration issued an alert to doctors, warning that gabapentin, along with 10 other commonly prescribed antiepileptic drugs, have approximately double the risk of suicidal behaviour or thinking compared with patients given placebos.
A year later, Health Canada says its experts are still reviewing the data.
Critics want restrictions on off-label promotion of drugs toughened and some are calling on doctors to get informed consent from patients every time a drug is prescribed off-label, something physicians are under no obligation to do now.
"The worrisome thing is, most doctors don't know what's on, and what's off-label use," Wilkes says.
Doctors can look up a drug's indication in drug reference guides found in every physician's office. But it takes time, and doctors are pressured more than ever to see more and more patients.
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Off-label prescribing is often unavoidable. It has been estimated that fewer than 30 per cent of drugs used in children have ever been tested in children.
Some of the highest rates of off-label use are for anticonvulsants, antipsychotics, cardiac medications and antibiotics.
Last November, researchers published a list of 14 widely prescribed drugs that urgently need study for the safety of their off-label uses. Heading that list was Seroquel, an antipsychotic approved for schizophrenia that is being used for bipolar disorder, depression and anxiety. The drug costs $207 US per prescription.
"We are prescribing these drugs (off label) that are often very, very expensive - it's rarely a generic drug, it's always some sort of trade name drug that has been marketed," Wilkes says.
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"Often it's really a shot in the dark, and the patient(s) may be the guinea pigs."
Wilkes says there are key questions patients should ask doctors every time they're prescribed a drug.
"What's the expectation, doctor, that this drug is going to provide the benefit you're saying, that it's going to relieve my back pain or improve my diabetes? Is this drug approved for this? What are the side effects I should be watching for?
"I think we do a horrible job of explaining to patients. We assume the package insert has it. There are 53 billion things mentioned for every drug. What you really need to know is, what are the two or three more common side effects that patients complain of that you should know about. If suicide is one of them, or depression is one of them, them automatically a light bulb goes off in your head because you remember, 'The doctor told me this.'"
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Widespread off-label drug prescription raises safety concerns
This ties in with the following threads:
http://www.coping-with-epilepsy.com/forums/f22/suicide-risk-11-epilepsy-drugs-2416/
http://www.coping-with-epilepsy.com/forums/f23/doctors-not-immune-sales-pitches-716/#post4494