Talk:Pregabalin/Archive 2

Archive 1

Archive 2

Generic pregabalin now available in UK

Actavis have launched a generic version of pregabalin in the UK [1], unfortunately I haven't found an independent source for this. This was the result of a court case over the patent [2]. January (talk) 14:13, 26 March 2015 (UTC)

Just to add a link from activis in support of previous posters assertion http://www.actavis.co.uk/en-gb/news/news/actavis-launches-pregabalin-capsules-%28lecaent%29

Addiction+dependence

Addiction & dependence citation - page 25

9.1 Controlled Substance LYRICA is a Schedule V controlled substance. LYRICA is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of LYRICA misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior). 9.2 Abuse In a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, LYRICA (450 mg, single dose) received subjective ratings of "good drug effect," "high" and "liking" to a degree that was similar to diazepam (30 mg, single dose). In controlled clinical studies in over 5500 patients, 4 % of LYRICA-treated patients and 1 % of placebo-treated patients overall reported euphoria as an adverse reaction, though in some patient populations studied, this reporting rate was higher and ranged from 1 to 12%. 9.3 Dependence In clinical studies, following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms including insomnia, nausea, headache or diarrhea [see Warnings and Precautions (5.8)], consistent with physical dependence. In the postmarketing experience, in addition to these reported symptoms there have also been reported cases of anxiety and hyperhidrosis. –FDA-approved Lyrica label

@Eharlacher91: This is the relevant cited material from the reference in the drugbox. There are no references to psychological dependence at all in this section. The material relevant to addiction indicates that there are no known pharmacodynamic relationships with addictive drug targets and there's no statistically significant euphoriant effect relative to placebo. If you want to state that this drug is addictive in this article, that's perfectly fine so long as you cite an appropriate medical source which agrees with the statement.

I'd caution you against reverting these 2 drugbox parameters again without addressing the sourcing issue that I've raised here, as the WP:3RR policy is relevant at the moment. Seppi333 (Insert 2¢) 04:09, 14 September 2015 (UTC)

Analgesic

This med is used for neuropathic pain but is not a general analgesic in that it does not appear to be useful for acute pain. Doc James (talk · contribs · email) 15:03, 4 October 2015 (UTC)

Dependence

@Skullballoons: I am concerned that the current lede gives an impression of a general dependence liability that is a little bit excessive based on the available sources.

• Reference 2 (or at least the Google machine translation thereof) lists the dependence potential as "slight", listing a total of 18 case reports
• Reference 3 I cannot read
• Reference 3 is a single case report
• Reference 4 describes 16 of the 18 case reports already described in Reference 2.
• A search of pubmed turns up a few papers also describing individual case reports, and an examination of the German spontaneous reporting database that turned up 55 spontaneous reports http://www.ncbi.nlm.nih.gov/pubmed/23292158

Given that this drug was used by millions of people, 73 isn't a lot of case reports. I'd suggest moving this material out of the lede and using more specific language than "There are indications of dependence for pregabalin in the European Union, relevant reports from Germany and Sweden", which is quite vague and could be interpreted as implying risk anywhere along a wide spectrum. I think the language I used referring to case reports would be a pretty accurate and reasonably precise description of what is in the literature. 70.214.20.118 (talk) 19:28, 27 September 2015 (UTC)

This weeks Case Notes on Radio 4 raise some serious concerns about this drug. Stub Mandrel (talk) 20:22, 6 October 2015 (UTC)

Content removal

Not sure why this was removed "As of 2015 no generic version is available in the United States. In the United States its costs about 3 to 6 USD per day." [3] Doc James (talk · contribs · email) 09:16, 24 October 2015 (UTC)

Removing side effects from the lead

The side effects of a medication should be given only slightly less weight than the effects with meds always being a balance of benefits versus harms. Thus not sure why the well referenced side effects were removed from the lead [4] Doc James (talk · contribs · email) 20:30, 24 October 2015 (UTC)

I agree with the comment by Doc James above. This should be restored. 70.214.3.2 (talk) 00:33, 25 October 2015 (UTC)

Poor source

This is poorly supported

" It's well known to be a faster-acting drug with a rapid onset of action, prolonged duration, greater bioavailability, higher potency and stronger receptor binding affinity. Pregabalin is fives times more potent than gabapentin with a proven potential for abuse and dependence. Which ultimately led to its control in the United States."

References

• This is a primary source [5]
• This is not suitable either [6]

Doc James (talk · contribs · email) 13:05, 23 October 2015 (UTC)

perhaps [7] ?--Ozzie10aaaa (talk) 13:34, 23 October 2015 (UTC)

Don't like that one either. Depressing that this has not been looked at in detail. $3B drug. 2600:1010:B06B:11F9:EB30:3CF2:EEF0:BAE4 (talk) 14:05, 23 October 2015 (UTC)

A mouse study and "eMedExpert", neither are useful. Ozzie's suggestion looks more promising. Alexbrn (talk) 16:12, 23 October 2015 (UTC)

Yes CADTH is a good source. Doc James (talk · contribs · email) 22:16, 23 October 2015 (UTC)

Does anyone here actually disagree with the content? If (to the best of our knowledge, etc.) the only question is whether we can find a gold-plated source to support it, then it would be preferable to WP:PRESERVE the content in the article (or as much of the content as we're reasonably certain of) while searching for a {{better source}}. WhatamIdoing (talk) 05:42, 24 October 2015 (UTC)

Yes I disagree with the content in question. For example I do not believe it is "five times more potent". I will look for better sources. Doc James (talk · contribs · email) 06:28, 24 October 2015 (UTC)

For pain I would not describe its onset as rapid. Its onset is over weeks. Half life is 5 to 7 hours for gabapentin while it is 6.3 hours for pregabalin. Hardly a difference.[8][9] Bioavailability is not clinically important. Doc James (talk · contribs · email) 07:09, 24 October 2015 (UTC)

Wikipedia isn't a guide for clinicians. "Not clinically important" is not an excuse for blanking material that you know is accurate. WhatamIdoing (talk) 01:04, 25 October 2015 (UTC)

The text sounded like puffery used in an attempt to promote a more expensive brand name over a similar med that is available as a generic. That is the issue I had with it. It was being given undue weight.

There are tentative concerns of abuse not proven concerns. Doc James (talk · contribs · email) 12:51, 25 October 2015 (UTC)