Medications Off-Label vs Off-Limits: Health Care Providers & the FDA

Medications Off-Label vs Off-Limits: Health Care Providers & the FDA

Doctors prescribe way too many medications for patients who don’t really need them, and I think a lot of the pressure comes from intense marketing from drug companies. Yet some comes from the fact that many patients refuse to leave their doctors office without a prescription for some type of pill.  And it’s unfortunate that physicians have too little time with each patient to explain non-pill solutions to problems. Wildly off-label prescribing is not new. Doctors have always gotten away with giving patients useless (and often quite harmful) drugs.

This is particularly true for cases in which medications are being prescribed “off-label.” Medication use in these situations is not based on any type of systematic study required for an FDA indication. Off-label prescribing has become a problem because any doctor can prescribe any drug for any problem in any case they feel necessary. It seems crazy to me-what’s the usefulness of the FDA if we aren’t taking what they say into consideration. I know in the past, I would never question anything my doctor told me-but now? You can bet I’m doing some of my own research before I pop any random pill in my mouth.

Doctors routinely give powerful drugs off-label to their patients, without knowledge of strong evidence that those drugs will be safe or effective or their patient, and sometimes despite warnings that such prescribing could cause serious harm. All the while, patients have no idea that the drug that’s being recommended to them has not been FDA approved to treat their condition, I mean we all trust our Doctors and assuming they know whats best for us, right?

According to the FDA, Neurontin is indicated for the treatment of Postherpetic Neuralgia in adults and partial onset seizures in adults and children with epilepsy. Simply stated, Neurontin (Gabapentin) was originally approved to treat epileptic seizures, and later approved to treat partial seizures in adults and children, in addition to neuropathic pain.

That’s it. Period. Believe it or not, the FDA indicated these intended uses, and these uses alone. In other words, there is no evidence that using this medication to treat anything other than these conditions will be safe or effective.

The unfortunate how often Neurontin is being prescribed off-label, and for a wide variety of conditions at that. Conditions including; fibromyalgia, chronic pain, bipolar disorder, alcohol withdrawal, migraine headaches and anxiety disorders are all being treated with this medication, it just doesn’t seem plausible that a single drug would be capable of correcting everything involved in each of these situations. However, while it may be legal for medical practitioners to prescribe medications for off label uses, it is illegal in the makers of this drug to market it for any uses other than those approved by the FDA. Whether ethically marketed or not, in the end, Neurontin has become so overly prescribed in the US medical community–I don’t even know where to begin. In fact, I’ve seen more people prescribed Neurontin today than any other drug on the market. And that’s no joke. It seems to be used everywhere.

People show up to treatment being prescribed Neurontin for a slew of different reasons, and when asking some of them what it was intended to treat, I heard responses like “well, I think it’s for my anxiety, or to sleep-something like that..” far too often.

I mean, you’re kidding right?

Believe it or not, Neurontin can be used to get high, despite not being considered a “controlled substance.” Through its effects on our brain’s reward system, it produces euphoria, almost mimicking a marijuana-like high or sedation, and, at high enough doses, even psychedelic effects. I think more people need to be made aware of the potential for Neurontin to be misused-because there is definitely a dark side to this drug and I can’t understand why it only continues getting worse.

The bottom line is that Neurontin is not used much for its original FDA approved indications and is way too commonly prescribed for off-label indications.  The only one of these off-label uses that seems to have any real evidence for being effective is for the treatment of Fibromyalgia and nerve pain. I can’t help but feel like Neurontin is almost like the non-opiate “go-to” drug at clinics that can’t understand or appreciate it’s potential for abuse.

Source: The Food and Drug Administration 

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