Latest MAOI updates 

by Dr Ken Gillman

The situation in different countries around the world is very different for all sorts of reasons so remember that these comments are international and may not always apply to particular localities.

It is likely that much of the comment here applies not just to Nardil, but also to many other less-used out of patent drugs of all kinds, not just psychotropics.  Thus, this is an illustration of the old quotation from John Donne ‘No man is an island…’.  Everyone is in this together.

This problem is likely to affect everybody everywhere, sooner or later, just like the Covid virus.

I have received information from all sorts of people all over the world and will try to condense here my deductions and thoughts about what is going on.

 

We continue to work on this international Nardil shortage problem, if you have any updated information please let us know by email

 

Email updates to PsychoTropical Research

Australia

Individuals can import up to 3 months for personal use (with a prescription) under the Special Access Scheme for TGA contact - ph 1800 020 653. Click here for more information about special access scheme

Product details Supply Impact Dates Further Details

NARDIL phenelzine 15mg (as sulfate) tablet bottle
AUST R: 93600
Active ingredients:
phenelzine sulfate

Sponsor:
Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Phone:
1800 181 060

Deletion from market:
02 Apr 2020

Status:
Discontinued

Patient impact:
Medium

Availability:
Unavailable

Reason:
Manufacturing

TGA Management Actions:
An unregistered product has been approved for supply under Section 19A. For details about ordering and supply please contact the approval holder - Medsurge Healthcare Pty Ltd (Ph. 1300 788 261).

(Sourced from: Therapeutic Goods Administration, Queensland Health https://apps.tga.gov.au/Prod/msi/Search/Details/phenelzine-sulfate)

U.K

Seigfried produce the API (active pharmaceutical ingredient) and their director Andrew Lamb says:

  • we currently have no intention to stop manufacture of this API and will continue to supply into existing markets as long as our customers' demand remains, .. Depending on the market demand, we will produce Phenelzine Sulfate every 12-18 months. … We will work proactively with Kyowa Kirin and with their nominated Contract Manufacturer(s) to supply API from the 2020 campaign and to plan the next production campaign after 2020.
  • there are a very large number of factors which influence the overall cost of a drug dose, including economy of scale, process complexity, raw materials costs, storage and distribution costs, R&D costs, etc.
  • I am confident that our partners are ready to resupply the UK market as soon as possible (initially from material transferred from Recipharm and then from the new Siegfried supply). I am also sure that each party is in contact with the right people to allow timely planning for future supply beyond this year.

Kyowa Kirin U.K. were using a contractor, Recipharm U.K., to manufacture* Nardil brand and their source of the API was from Siegfried CH . 

*In the sense I think ‘manufacture’ means to make it up into tablets with the appropriate colourings and excipients, but I’m willing to be corrected on this detail

Recipharm seems to have been ‘closed down’ by the U.K. MHRA due to cross contamination.  Kyowa Kirin U.K. are as far as I understand it a mere intermediary in this process since they don’t produce the API and they contract out the production of the tablets.

Phenelzine (Nardil®)15mg tablets updated memo click here

Possible importers:

Importer Contact details 
Alium Medical Tel: 020 8238 6770
Email: enquiries@aliummedical.com
Chemys Limited Tel: 02085008497
Email: orders@chemys.co.uk
Clinigen Group PLC Tel: 01932 824100
Email: ukcustomerservice@clinigengroup.com
Durbin PLC Tel: 0208 869 6555
Email: Imports@durbin.co.uk
Ethigen Ltd Tel: 0800 019 7100
Email: specials@ethigen.co.uk
Mawdsley-Brooks & Co Tel: 01302 553000
Email: customerservices@mawdsleys.co.uk
Target Healthcare UK Limited Tel: 08456 180036
Email: specials@target-healthcare.co.uk
Thistle Pharma Limited Tel: 0800 169 9765
Email: contactus@thistlepharma.com
WEP Clinical Tel: 0208 004 8185
Email: info@wepclinical.com

(Sourced from Pharmacy Business https://www.pharmacy.biz/nardil-15mg-tablets-likely-to-remain-out-of-stock-this-year/)

U.S.A

Far as I can ascertain there has been no major supply issue in the USA even if some people have had difficulty getting supplies at one time or another there has still been supply available somewhere. The information below has been received from the FDA.

Labeling for most FDA approved drugs may often be found on CDER's page at DRUGS @ FDA:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

‘We take concerns about drug treatments for depression and other psychiatric conditions very seriously.

FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage. However, as a regulatory agency, FDA cannot require firms to increase production or to continue making a particular product or active pharmaceutical ingredient (API) if they are not willing to do so. Please understand that this is because FDA does not have control over firms’ business decisions.

As noted by FDA’s Drug Shortages Staff in an email to Mr. Johnston, in the U.S., phenelzine supply is currently available from an approved manufacturer, Lupin Pharmaceuticals. If your patients or anyone you know is having issues with obtaining supply of phenelzine, please contactDrugShortages@fda.hhs.gov

Individuals in the U.S. who contact you to FDA (drugshortages@fda.hhs.gov or druginfo@fda.hhs.gov) and we can try to determine if there are supply issues in the United States. 

In terms of inspections: as noted on the COVID-19 and Beyond: Oversight of the FDA's Foreign Drug Manufacturing Inspection Process page, most foreign and domestic surveillance facility inspections are currently postponed.  Only inspections deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.

GoodRX is not an app in the Apple store, but it is accessible through a website: 

Prescription Prices, Coupons & Pharmacy Information – GoodRx

 

Belgium

Belgium has own online supply channel

Denmark

We have 1,500 packs of Marplan that can be initially shipped: Each containing 56 tablets (10 mg). 

The issue is that we are only in a position to deliver packs with Danish text. 

Although we do have full English translation of both Label, SPC and the Patient Insert Leaflet.   

 Another good news is that we are now 99% sure that Medilink is in a position to deliver a second round of Marplan by end of August.  From August Medilink would be in position to deliver whatever demand needed. 

Therefore, the 1,500 packs would correspond to 500-700 patients, that can be treated with an MAO-inhibitor right now. 

www.medilink.dk

Italy

No MAOis available.

It is possible to import TCP from Germany via Switzerland but it is very expensive (about 250 dollars/month for 30 mg/day dosage).

Spain

No MAOis available.

Expensive and long import procedures required

India

India based Lupin. They continue listing Phenelzine on their website. They inherited Phenelzine after buying Somerset Pharmaceuticals (the developer of EMSAM) which had  bought Nardil from Pfizer.

http://www.lupinpharmaceuticals.com/productlist.htm#product_p

MAOIs for psychotic depression — the nature of evidence

RCTs are merely sales gimmicks, beguilingly tricked up as a verisimilitude of scienceFor decades I have been puzzled by the readiness of psychiatrists to give dopamine antagonists, antipsychotic drugs — anti-what-sort-of-psychosis, one might ask — to patients with...

MAOIs – International shortage

MAOIs - International shortage by Dr Ken Gillman Nardil shortage overview The situation in different countries around the world is very different for all sorts of reasons so remember that these comments are international and may not always apply to particular...

Latest MAOI updates

Latest MAOI updates  by Dr Ken Gillman The situation in different countries around the world is very different for all sorts of reasons so remember that these comments are international and may not always apply to particular localities. It is likely that much of the...

MAOI shortage letter introduction

MAOI shortage letter introduction  by Dr Ken Gillman The availability of these important MAOI drugs is diminishing worldwide and there may now be a crisis of supply concerning phenelzine (Nardil).  I use the words ‘may be’ because it is hard to ascertain facts in...

New review of TCP

I would like to draw everyone’s attention to this significant paper by Sven Ulrich and his co-authors for this most useful and significant paper on TCP [1]. For this initial rapid response comment I make no apology for citing the abstract of the paper in its entirety...

MAOIs, selective and or reversible

Introduction This commentary covers Selegiline, rasagiline, and moclobemide which is far as I know are the only such drugs are available, although others, such as ladostigil, are on the horizon. First, one should appreciate that some ‘selective’ drugs are only...

Swapping from one MAOI to another MAOI

The requirement or desire to swap from one MAOI to another MAOI is something that will be an uncommon occurrence.  Furthermore, it will be an urgent need even more rarely.  It may be indicated, for instance, because of the excessive weight gain, sexual dysfunction, or...

MAOI updates 2019: Clarifications concerning pharmacology and terminology

IntroductionThe first objective of this commentary is to clarify misunderstandings about the range of clinical usefulness, and the pharmacology and side-effects, of these (MAOI) drugs, which are not clearly explicated in current sources, including FDA approved product...

MAOI Diet Drug Interactions

Monoamine oxidase inhibitors: A review concerning dietary tyramine and drug interactions Abstract This comprehensive monograph surveys original data on the subject of both dietary tyramine and drug interactions relevant to Monoamine Oxidase Inhibitors (MAOIs), about...

International MAOI expert group: Editorial and recommendations

I am proud to announce that the position statement and recommendations produced by my International MAOI expert groups has been published as an editorial in CNS Spectrums. The title is ‘Revitalizing monoamine oxidase inhibitors: A call for action’...
Youtube
Youtube
Apple Podcast
LinkedIn
Reddit
Facebook
Facebook
Twitter
Visit Us
Follow Me
RSS
Skype
PodBean
Research Gate
Google Scholar
Spotify