Talk:Off-label use

I am not qualified to do so, but it would be appropriate to have a discussion in the article of the Oregon Death With Dignity act. The U.S. Attorney General attempted to block that state-enacted law by appealing to the illegality of off-label use of controlled substances for physician-assisted suicide. Diogenes 17:45, 30 September 2005 (UTC)

Amphetamine is a scheduled substance, yet commonly prescribed off-label, as the article indeed says. At the same time, the article says that scheduled substances cannot be prescribed off-label. Why the discrepancy? Is there a legal distinction that causes it?

Off-label use is a murky matter, and whether any particular scheduled drug is treated as off-limits by the DEA is more a matter of practical enforcement than of any written law. On an unrelated note, a more international view would be nice-- how does this work in the UK, or in the EU for instance? Kajerm

Disputed

The article incorrectly states that Atomoxetine (Strattera) is the only drug with FDA approval in the U.S. for adult ADHD. Since August of 2004, Adderall XR, an extended release amphetamine, has also been approved for this use.[1][2]Hans Walling 18:25, 25 April 2007 (UTC)

According to recent discussions (May 2007) with FDA officials, the practice of writing "off-label" prescriptions for narcoticsIS allowed by physicians without penalty. In the case discussed, the narcotic drug "Actiq", or generic fentanyl lollipops, are currently used for breakthrough pain in many diseases. And it is documented in other articles found on the internet and in magazines that only 1% of the prescriptions for this medication are written for the purpose marketed by the pharmaceutical company. Physicians have found a way of treating other diseases, besides cancer, whose sufferers can find no other medication unless their physician is willing to write "off-label" prescriptions to relieve the severe pain of their patients. Rebeccaj1009 00:34, 23 May 2007 (UTC)

It is perfectly legal in the U.S. to prescribe controlled substances off-label. It is, however, illegal to market drugs for off-label uses. Many controlled substances are written off-label. The most common is probably Actiq, which is only FDA-approved for "breakthrough cancer pain" but is prescribed for all sorts of moderate to severe non-cancer pain. It is worth noting that all the citations to the alleged "fact" that controlled substances are legally treated different than other FDA approved medications contains NO citation whatsoever. It is important that this false, and very unfortunate misconception not be propagated any further. I'm going to attempt to correct this entry again, and hopefully the erroneous information won't be put back by whomever it is who thinks they know what they're talking about but clearly does not. For what it's worth, I am a lawyer (though none of this is intended to be, or may be taken as, legal advice). —Preceding unsigned comment added by 98.196.110.71 (talk) 09:58, 22 March 2008 (UTC)

Drug and device

I think the article should indicate that it is drugs and devices that can be used off label. In the opening I would be inclined to say "Off-label use is the practice of prescribing drugs or medical devices for a purpose outside the scope of the product's approved label, most often concerning the drug's or the device's indication for use." Then throughout the article the language should reflect both drugs and devices. An example of using a device off label would be using a hemodialysis machine for home nocturnal dialysis www.homedialysis.org/files/pdf/resources/links/HomeHemoFDAMeeting.pdf BillpSea (talk) 18:20, 5 January 2008 (UTC)

Bevacizumab (Avastin)

The examples section says that clinical results for intravitreal injections of Avastin are anecdotal. There is a growing body of research being published in reputable medical journals worldwide indicating that it is a valid treatment. To date, calling the results anecdotal is an opinion, and thus not in keeping with WP:NPOV. That is why I have deleted the conjecture at the end of the example.Garvin ^Talk 02:41, 10 April 2009 (UTC)

Off-label prescribing for children

Am I correct in believing, and would it be useful to add to the article (given suitable citations), that many if not most of the drugs that physicians prescribe for children are being prescribed off-label, because ethical considerations make it very difficult to conduct drugs trials on child subjects, and consequently most drugs are not approved for them? 87.81.230.195 (talk) 15:08, 30 December 2009 (UTC)

Numerous flagrant violations of balance

This article incorrectly states the law on off label prescribing of off label drugs, it also is unbalanced, citing only positive examples of off-label use, and not the numerous examples of off-label ADR, such as fen-phen. It also does not talk about how drug companies have ghosted or otherwise planted research in an effort to make it seem as if a drug had had independent clinical research proving an off-label use, when in fact it had been drawn from the data already rejected by FDA, for example Merck and Vioxx. 71.174.43.137 (talk) 07:52, 30 January 2010 (UTC)

If you have reliable sources for this, why don't you add a criticism/controvery section? stmrlbs|talk 16:18, 30 January 2010 (UTC)

Transition to on-label use

Either this article or another article linked from here should discuss the process to get an off-label use approved on-label. For example, in the United States, the FDA approved Zyban (bupropion for smoking cessation) after Wellbutrin (bupropion for clinical depression), and Revatio (sildenafil citrate for heart therapy) was approved after Viagra (sildenafil citrate for erectile dysfunction). Is it just a New Drug Application that reuses the previous phase I, or is there a separate application for this? --Damian Yerrick (talk | stalk) 12:16, 22 August 2010 (UTC)