MAOIs – International shortage

by | Last updated Jul 13, 2020 | Published on Jun 19, 2020 | Anti-Depressants, MAOIs

Nardil shortage overview

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.

First, the background of changes in many aspects of laws and regulations relating to commercial activity internationally, and the production of drugs especially, have been influenced by lobbyists for the pharmaceutical industry and have influenced international treaties concerning trade.  In some instances that may make it more difficult other countries to source cheaper drugs.

Next, we have the factor of the changes in various standards and regulations relating to the production of pharmaceutical raw materials.  Some producers may not wish to make the investment necessary to accommodate to these changes — it is possible that some gamesmanship going on between the regulators and producers.

Chemicals may be formulated into medications by different companies and it can sometimes be difficult to know who is manufacturing the raw material, as opposed to who is packaging it, or distributing it.

Present information indicates that there may be just two producers of the phenelzine sulphate chemical, Lupin in India, and Kyowa Kirin in Japan.  Many sources say that the producer is X or Y, but what that really means is they are buying the raw chemical of somebody else and then making it into whatever form they sell it in — so they are really formulators and packagers, i.e. processors not ‘producers’.

Also, different Countries have different regulations about who the licensed importer is for a drug, also, which source they are licensed to imported it from.  Bureaucracy is notoriously inflexible in relation to such things.

Next, there is the difficulty of ascertaining whether companies are still producing a product, or whether they have been taken over by a different company: e.g.  Greenstone are a subsidiary of Pfizer.  It looks like such issues are relevant, particularly regarding Nardil, where (I think) Novel pharmaceuticals in New Jersey used to ‘produce’ it for North America, but were taken over by Lupin, an Indian company.  They, like Kyowa Kirin, appear to be unable to satisfy the FDA inspectors because some aspects of the production or procedures do not meet their approval standards.  Whether or not this means they have temporarily ceased producing phenelzine, or precisely why, or for how long, is difficult to ascertain.

It is probable the total world market for phenelzine is not more than $1 million.  Most new drugs measure their sales in billions, so $1m is a trivial amount.

At the end of the day what appears clear is that Nardil has been produced successfully for 50 years; furthermore, no agency has issued warnings about it, or withdrawn it, because of chemical stability or impurity issues.  But just recently the FDA appear to have decided it is somehow ‘not good enough’ and have been unable to effect the transition to a better product without causing this worldwide chaos.  To an outsider armed with the present information this would seem to be a rather unfortunate course of action that does not take adequate account of ethics and patient welfare.

It seems that none of the commercial enterprises concerned have a sufficiently keen perception of the public good to continue production when the profit is so insignificant.  It may also be that those making decisions in the major agencies like the FDA and the European EMA also have an insufficient perception of how these decisions impact patients and cause real and immediate harm, or even deaths.  Patients are caught in the middle.

I suspect the fact that it does not appear to be in short supply in the USA at the moment may be explained by the fact that USA wholesalers are much larger and probably hold more stock than other suppliers and have thus got a bigger buffer before they run out.  However, unless Lupin can restart production soon there is almost certain to be a gap where no supplies available even in the USA.  That will mean there is truly a total worldwide unavailability, possibly except for certain laboratories in China supplying it via the dark web.

I therefore conclude that the only likely remedy is that members of the American Senate and European Parliament, instruct and allow the FDA and EMA come to an accommodation with which ever manufacturers are relevant.

We at PsychoTropical continue to do what little we can and are making our best effort to provide whatever information is available, but it is important for everyone to understand that unless there is a grassroots protest it is probable that nothing will be done.  Support any petitions, and make as much noise as you can, in whatever way you can.

For some reason the relevant players, i.e. regulatory bodies, and professional organisations, do not appear to be on top of the situation.  The interests of vulnerable patients have not been safeguarded.

Donate if you can, if it was not for one substantial donation by an individual who wishes to remain anonymous, we would not be able to do what we are now doing.

Addendum re Lupin from Economic times, India times (Dated 14/6/2020)

NEW DELHI: Drug major Lupin plans to approach the US health regulator for re-inspection of its manufacturing plants in Goa, Pithampur (Madhya Pradesh) and Somerset (US) in the next few months.  The company’s Unit 2 manufacturing plant in Pithampur, along with its Goa site, is under the US Food and Drug Administration’s (USFDA) warning letter since November 2017 for violation of current goods manufacturing practices.

Read more at:
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/plan-to-approach-usfda-for-re-inspection-of-key-plants-in-next-few-months-lupin/articleshow/76367915.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

International Supply news

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)

More information:

Professor Brendon Murphy Chief Medical Officer of the National Health commission and Christine Morgan CEO of the National Health Commission recently sent out a joint media release 15 May 2020 about the $48.1 million for National Mental Health and Well-being Pandemic Response plan .

This investment builds on approximately $ 500 million for mental health and suicide prevention announced by the government since 30th January 2020, including $64 million for suicide prevention , $74 million for preventative mental health services , and a significant proportion of the $669 million telehealth package to support MBS subsidised treatments provided by GP’s, psychologists , psychiatrists and other mental health professionals .

 $2.6 million investment will boost National capability in monitoring and anticipating and reacting to the mental health impacts of the pandemic .

The Australian government have whipped up enough funds for mental health support during the pandemic but do NOT have funds or refuse to address funds for many suicidal patients having no choice to stop taking their only available medication to sustain a stable mental health during this pandemic !

 Clearly the Prof . Brendon Murphy should be in the firing line here and fully responsible for the Australian government to urgently review this crisis of not funding SAS medicines during this pandemic!

The Australian government could not of chosen a more unsuitable time to cut off many patients lifelines to their medication who desperately need Nardil Phenelzine Sulphate .

They should use part of the $2.6 million  budget for mental health during this pandemic to urgent facilitate SAS medicines . 

Bureaucratic red tape seems to clearly be the case here .

U.K

The UK manufacturer Kyowa Kirin Ltd sent out press releases stating that the shortages were temporary on several occasions giving dates when the supply could be expected to recommence. None of these dates were ever adhered to and to this day the company has not recommenced manufacture of Nardil.

The U.K. Department of health have had emergency meetings with Ascot Pharma here in a laboratory who have been given the go ahead to urgently compound Phenelzine Sulphate as a white powder then place into capsules

All U.K. patients Must get their GP to write an NHS script as a special but issue as Phenelzine sulphate CAPSULES SPECIAL . The patient then needs to get their pharmacist to open an account direct with following pharmacies:

Ascot Pharma  by telephoning 01923 711971 Direct contact re stocks : Rakesh @ascotlabs.com

Sigma Pharma Watford tel 01923 444999 Phoenix Pharmaceuticals David Lea email ; dlea@phoenixmedical.co.uk Tel : 01928 750605. White capsules 

 

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

Nardil in the US is manufactured by Greenstone Pharmaceuticals.https://www.greenstonegenerics.com/home/?cmp=GRSSEMGRE

This is available through the GoodRX app instructions below:

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

Prescription Prices, Coupons & Pharmacy Information – GoodRx

 

Rite-Aid (a USA chain) had phenelzine in stock

Sporadic Supply throughout USA
Safeway in San Francisco. They get their supply
 from Greenstone pharmaceuticals which lists Nardil on their site with no supply notice. Safeway also said their warehouse has plentiful supply.

Canada

Nardil is currently unavailable in Canada. It has been in shortage since 2019, and has been on back-order for several months. The date of resupply has been delayed three times. Erfa Canada 2012 Inc. is the distributor of Nardil in Canada. They have stated that Nardil will be available sometime in July 2020.

 https://eci2012.net/

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

I started taking Nardil when I was 27, and it was life-changing

At age 16 I found it difficult to attend school. I ruled out university when I finished. At around 26 I was still in the same cafe job I had had when I left school. I told myself I would end my life at 30 were I still in the same circumstances. Life is hard to enjoy when you are scared of human interaction.

I started taking Nardil when I was 27, and it was life-changing. The symptoms of social anxiety quickly disappeared, and I began to ENJOY the company of others. It is remarkable how much your life changes when you are able to truly connect with other people. So much of what makes us happy and content with our lives comes from human interaction. Perhaps it sounds cheesy but I really didn’t know how lonely I was until I wasn’t.

My newfound comfort with human interaction meant the future no longer looked grim. I enrolled into university and was two years into a law degree when I was no longer able to find any Nardil.

It has been around 6 weeks since I stopped taking Nardil (I stopped because I couldn’t get more, not of my own volition). I have been unable to study, my moods are too volatile. On a few occasions I’ve cried hysterically for entire Zoom sessions for no reason at all. Consequently I failed two units this semester. I still have to pay for them.

Aside from these withdrawal symptoms that could have been better managed had there been better communication about the discontinuation of Nardil, I’m also scared the social anxiety symptoms I had previously will return. I have tried CBT, and various other AD medications including Parnate in the past so I’m not really sure what will happen to me now. I hope I can still finish uni.

Whatever happens, I’m grateful for the past few years I was on Nardil. I’ve met so many people and done so many things I didn’t think I was capable of doing.

Doctors who have been unwilling to prescribe MAOIs, have been brainwashed

The doctors who have been unwilling to prescribe MAOIs, who have been brainwashed by the lie that “MAOIs are dangerous,” are to blame for this. Instead of prescribing an extremely effective MAOI like Nardil, the damn fools will go and prescribe an SSRI + atypical antispychotic + a mood stabilzer + a benzo, etc etc….and even after all these meds, the patient is still ill and only needed an MAOI. SSRI monotherapy works for people with only “situational depression”, a type of depression that can actually be treated without medication.

People on Nardil very often have no other recourse

As with many others, prior to Nardil I tried SSRIs, TCAs, mood stabilizers, atypicals, etc. These medications helped hardly at all, in fact some exacerbated the symptoms. In contrast, Nardil is truly amazing, completely eradicated depressive symptoms, and almost all anxiety symptoms. Nardil allows for full functioning, that is, to actually participate fully in life, rather than being almost completely housebound due to severe, intractable anxiety and depression.

Nardil was a last resort!

It took six long years of trying almost every drug available at the time, numerous hospitalisations, two courses of ECT and two suicide attempts before my psychiatrist gave me Nardil (Phenelzine) and he said at the time it was a last resort! I have now taken it for the last 35 years and it has given me a good life and a lovely family, neither of which I would have had without it.

The anxiety I experience every day about the next bottle being my last is absolute torture. I really don’t see much of a future for myself if I can no longer get it!

Nardil literally SAVES LIVES

Nardil has changed my life immensely, it has allowed me to function well when no other medication (SSRI, SNRI, TCA, atypical antispychotic, psychotherapy even Parnate) has allowed me too. Before Nardil I was hospitalized and was a burden on everyone around me.

I am in a constant state of fear now, I have reduced to a sub-therapeutic dose of 30mg, and my symptoms have returned- severe anxiety, anhedonia, suicidal ideation, etc. Without this medication, I will not be able to function. Period. The supply needs to be reinstated because this medication is immensely helpful (and under-prescribed) and it literally SAVES LIVES.

Nardil helped me tremendously

Nardil helped me tremendously in managing my panic disorder, social phobia & GAD. I’ve never felt better in my entire life. It improved my mood, concentration and my overall mental health.

The shortage has severely impacted my physical and mental state, as my original symptoms has returned and are worsening.

Obviously this is not acceptable and supplies should be reinstated quickly

 

With nardil my life is transformed to one worth living

Without Nardil I’m reduced to bed in non stop agony unable to function, self care, get dressed or stay on top of these things. I don’t have any quality of life. With nardil my life is transformed to one worth living.

The shortages have worsened my condition and had a directly bad impact on my state.

It’s been non stop stress and my next step is unfortunately suicide.

Useful links to Nardil information for patients:

Sign the end Nardil shortage petition created by a passionate and driven patient who is reliant on Nardil along with over 1900 other people who NEED Nardil to function.

End the shortage of the MAOI anti-depressant Nardil (phenelzine Sulfate)

or more Nardil patient support  go to nardil.org

This site includes useful support groups such as below and more success stories and information.

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