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QUESTION: without going into the name of the expert,he stated that gabitril is as safe as i  know gabitril has no studies done on non-epilectics taking gabitril for even 6 fact on the insert  ofthe   gabitril medicine there is  warning about non-epilectics taking gabitril/remeron haS BEEN AROUND OVER 10 YEARS AND IS TAKEN BY 10 TIMES AS PEOPLE WHO TAKE GABITRIL.SIDE EFFECTS APPEAR sometimes years after medicice is introduved example crestor.the expert who said gabitril and remeron are equal is a psychiatrist.your opion?

ANSWER: Howard

Whilst there may be no definitive clinical evidence (randomised, double blind studies) that one product is any better, worse or equivalent to another, there will always be prescribers who choose to use such products in the absence of this evidence. Many will have anecdotal experience that justifies their views and is difficult to challenge (because it is unbalanced perception).

However, the reality is that use of a treatment outside the terms of its Marketing Authorisation (Product Licence) means that the product is effectively unlicensed. Whilst the drugs company may be interested in the outcomes, they would be able to refute any claims from harm (unless the product is shown to be defective). This places the responsibility / liability on the prescriber and the patient who should know of the potential risk, and make informed decisions.

If you and your doctor are happy to take / prescribe a product on these terms, then you can of course do so. You may indeed find there are benefits, but that is not guaranteed. If nothing else, the drug company will have considered whether their data was strong enough to support licensing or whether the trials would be justified economically.

Like many things, the patient needs to make the decision with full understanding.

I hope this helps.

---------- FOLLOW-UP ----------

QUESTION: in simple terms has there been reports that gabitril is not safe for non-epilectics to take.i read a report that less then 1%of non-epilectics who take gabitril get seizures?


Although the numbers may have been small at the time (2005), both in absolute numbers and as a percentage of users / prescriptions, the US FDA were obviously sufficiently concerned about possible risks of seizures to issue an official warning and require manufacturers to alert prescribers.

The warnings still persist in the current clinical data sheet for the product:

Seizures in Patients Without Epilepsy: Post-marketing reports have shown that GABITRIL use has been associated with new onset seizures and status epilepticus in patients without epilepsy. Dose may be an important predisposing factor in the development of seizures, although seizures have been reported in patients taking daily doses of GABITRIL as low as 4 mg/day. In most cases, patients were using concomitant medications (antidepressants, antipsychotics, stimulants, narcotics) that are thought to lower the seizure threshold. Some seizures occurred near the time of a dose increase, even after periods of prior stable dosing.<<

None of this means that every patient will get seizures, just that some might, especially if they are taking a number of drugs acting on the CNS.

Whether Gabitril should be prescribed depends on clinical need and the willingness of the doctor and patient to take the risk.

I hope this helps.


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Nigel Simmons


I am happy to answer general questions on medicines and hospital care. If possible, please use approved / chemical names rather than brands which are not internationally recognised. Like all health professionals I am bound by a duty of care which prevents me giving detailed information about medication or treatment of people other than the questioner. I will endeavour to help wherever possible or point towards more appropriate advice. If however your question crosses too far into patient confidentiality, I hope you will understand why I cannot answer your question. Consider.. would you want me to discuss your care with a friend or relative without your knowledge?


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