Working in a pharmacy, people bring us all kinds of strange news pieces: pharmacies being robbed in new and creative ways, and studies about X drug causing Y problem. Today someone brought in a piece of news from USA Today — not my favorite newspaper for myriad reasons. One of them is their propensity for building stories around what amounts to hot air. This one is no exception. Provocatively titled “1 of 7 prescriptions are ‘off-label'”, Ms Ruben builds a hype-driven story around a 2001 study which concluded that some 21% of prescriptions are written to treat conditions for which they were not explicitly approved.

I do not doubt the accuracy of the study — truth be told, I’m surprised it’s not closer to 35% — but it is certainly no cause for alarm, or even a mention in a mainstream newspaper. The piece is pure fear-mongering, and the 6 medications that are specifically cited are largely broad-spectrum drugs. These are only available in the print edition of USA Today, but here they are:

• Neurontin (gabapentin) — epilepsy, PHN
• Risperdal (risperidone) — schizophrenia, mania and BPD
• Restoril (temazepam) — short-term insomnia
• Ciloxan(!) (ophthalmic ciprofloxacin) — eye infections
• Elavil (amitriptyline) — depression
• Pamelor/Aventyl (nortriptyline) — depression

While I won’t go through each of the drugs listed about specifically, I will talk about them (and their cousins) in very general terms. I will give Ms. Ruben one thing, though. She did mention that many of the name-brand drugs no longer have patent protection, and so it wouldn’t be profitable for their respective manufacturer’s to seek approval for a broader range of conditions.

1. Neurontin is a drug that is barely understood. It is approved by the FDA for two uses, postherpetic neuralgia and epilepsy, but it’s used for many, many other things. Among these uses are chronic migraines and “zinging” nerve pain not associated with shingles. New uses are found for gabapentin on a regular basis. It is unlikely that any of these off-label uses will ever be officially approved simply because Pfizer has financial motivation to pay for the process.

2. The *triptylines (and I’ll throw Desyrel/trazodone in there as well, even though it wasn’t listed) are old drugs, and they were originally used as tri-cyclic antidepressants, but they had a other effects on the body as well. Trazodone and amitriptyline can be used for sleeping, and the latter can be used for bed-wetting. Nortriptyline is often used as a pain medication in select cases, and can also be used to treat migraines. These uses are widely accepted and understood, but like Neurontin, their mechanism of action and why they work is not fully understood. Also like Neurontin, their patents have expired, and it wouldn’t be a wise financial move for their manufacturers to pursue getting them approved for other uses.

3. Ciloxan is nothing but Cipro in eyedrop form. Cipro, of course, is a well-known antibiotic used to treat many different kinds of infections. It stands to reason that the eyedrop form might be used to treat similar infections in the eye and (sometimes) the ear. (Though there are otic forms of Cipro already.)

4. Restoril is in the benzodiazepine family. The grandaddy of all of the benzos, of course, is Valium. There are others: Ativan, Xanax, to name a few. All of them are nonselective. They all work on the same GABA_A receptors. What is different is the half-life. Temazepam happens to have a half-life that is conducive to a good night’s sleep, and that is the only reason it’s used as a sleep med.*

5. Atypical antipsychotics fall in the same gray area that the tri-cyclic antidepressants do. They aren’t well understood, and new uses for them are being found all the time. Yesterday I mentioned Seroquel, and I said that it was sometimes used to help those taking stimulants to combat ADHD. Well it is, and Risperdal and other similar medications are used in novel ways as well.

It’s sometimes shocking to those outside the medical field just how little is known about drugs and how they work. What is known, however is that they do work. Perfect understanding is never a requirement for usage, and to expect otherwise is hypocritical and foolish.

* There are other small differences that set the benzos apart from one another as well, such as dosage and how rapidly they are absorbed.

[tags]Prescriptions, pharmacy, off-label drug usage, journalism, bad journalism[/tags]