I'm glad we found YOU, however, I regret that your ET seems to have morphed into PD.

Your talents at information research and youthful enthusiasm and positive outlook are a major plus in our efforts to keep up the fight!

http://www.hc-sc.gc.ca/dhp-mps/compl...c_2009-eng.php

I just read the entire listing of drugs recalled and the reasons for the recalls at this facility. This reads like a third world sweatshhop enterprise. Or is this a case of finding problems if one nit picks enough? Are the manufacturing transgressions really so bad, in which case someone has been asleep at the helm, both in the company and within the investigating/regulating entity. or is this company being driven out of the market? are these findings easy for any regulator to produce? Many of the products are alternative supplements or veterinary products. I know there has been a major push to stop manufacturing and sales of OTC vitamins and supplements by any entity other than Big Pharma. Or did this company really need to cease production?

A sign of the times, this inability to trust those who have been entrusted with our safety and wellbeing.

all becoming more and more curious.

The Apotex long acting Levodopa/carbi had problems about 3 yrs ago too. It was unavailable for several months.

This is not the first company to have this type of problem...

Ethex had all of its products taken off the market just over a year ago!

And it is not only generic houses... Schering Plough had all of its extended release products recalled years ago! And some inhalers which contained NO ACTIVE ingredient. Their albuterol was unavailable at the time, and so was Vanceril. Vancenase AQ was taken off the market. This massive recall was in part a portion of the reason the company was failing and had to merge with Merck. (its OTC line was the only thing making money for it for a while).

Even Big Pharma...Glaxo was making an extended release form of Paxil (to extend their patent) which was discovered to be failing dissolution standards, and was recalled. It was unavailable for over a year!

Extended release products are always iffy... prone to problems.
Another area with issues, is the trandermal patches.

Would be very interested to hear more about difficulties with transdermal patches, they are being introduced for more conditions, and if there are problems, well yess, I have used one of these products, had problems.

Thanks Mrs D for your always useful information.

Lindy

wow what a difference a day makes. mrs. D you are supplying so much information! this is getting life threatening and i appreciate the heads up to the recent posts...i never used it. to laura - i see no sides to take, we are all working on the same side. actually i asked for an attorney to make sure we don't get ourselves in trouble for what we say and do about this, so i should have clarified that. personally, i think too many lawsuits are behind so much of the high prices we have today. i thought maybe someone could be around for advice .

having said that - i am dismayed that the FDA is involved, Olsen thanks so much for that information. Is it that bad? They take so long - but why is it that they seem to know the date that things will be restored?

So could we be taking bad drugs? Just what we need. it's only human to get emotional about this "one more thing" that appears to come from pharma. this time i think we are fed up - people don't realize how much we are watching. telling doctors to switch to alternative medication is just not enough information.

thanks to all for providing the information. it is a must to empower us to act.

paula

Transdermal patches are an outgrowth of NASA technology originally planned for astronauts.

The first one was TransdermScop. Scopolamine for motion sickness. Then came Nitroglycerin patches. Then Nicotine patches, then a flurry of other drugs joined the ranks.

TransdermScop has had 2 recalls and one reformulation that I remember.
There have been numerous recalls on Duragesic and generic fentanyl patches, and these have been serious and the flaws have led to deaths. This drug is very very potent and any error in delivery is critical.

But others recalled are NeuPro (for PD patients),
Ortho Evra (contraceptive) delivering too much estrogen
Daytranna (methylphenidate) -- this one has had EIGHT recalls.... http://industry.bnet.com/pharma/1000...pull-the-plug/

The technology used in the patch is very sophisticated. Release of the drug has to be carefully planned and since most of the drugs used, so far in patches are tiny doses anyway, any error in release or use, or in manufacture, may upset the delivery system.
Duragesic finally changed from a "reservoir type" to a matrix type to avoid further abuse of the patches (which happens) and sudden dumping of the drug into the blood stream, which can lead to OD and death.

The technology of sustained release oral dosage forms is sensitive too... and these types of oral drugs may be recalled as well. (as I listed in the prior post). Brand name companies are not immune to these errors.

Update to postings number 48 and 49 in this thread.
Earlier this year, Merck announces drastic cuts in supply of sinemet to Spain.

Feb. 17: Spain – rebel group of Parkies demand that their government take legal action against Merck, not civil lawsuits for damages… criminal charges.
Feb. 21: Merck suddenly starts to communicate. They can rip off supplies from other countries where they are not facing time in federal penitentiary. And the production problem? What production problem? Who every made you think there was a production problem?

(Rough translation by Google)

17 feb 2010
Dear Sir

DISINFORMATION FROM THE MINISTER OF HEALTH (Spain)
…The Minister of Health, Trinidad Jimenez, was asked what had happened to the Parkinson's drug shortage, to which the Minister failed to respond. The Minister must know what is happening as a person who has to ensure the health and welfare of the citizens of this country, some people with a neurodegenerative disease, incapacitating and disabling.
It seems very strange that the Minister is unaware of the situation when the National Association of People with Parkinson TARAY, after doing their own research on the 4th of this month comes in contact with the company in commercializing the drug MSD Spain (Sinemet) and they tell us they have no stock of the drugs and they are looking for a supplier they cannot restore the domestic market until 2011.
From this moment, our group has been in contact with the Department of Pharmacy who is in the same building as the Minister of Health, from whom we have had no response whatsoever. We also got in touch with the Spanish Agency of Medicines; after much stress tell us they have obtained a commitment by the MSD.
Gentlemen, these are not commitments, these are obligations that the company has to fulfill certain laws, which must have a minimum of stock and if they fail the law requires they be punished like any citizen, they are playing with the health of many people.
Who is to deceive, if the 4th of this month there is no medication in stock…., if they have the supplier of the active ingredient? How can already supply the market?
Not if you understand it but I do not understand anything and the Minister and the Federation of People with Parkinson’s being quiet as if nothing happened…

Muchas gracias
Atentamente
Francisco Fernández Cimas
Vicepresidente Asociación Nacional Parkinson TARAY
Manuel Serrano, 23
28300 Aranjuez (Madrid)

Spanish version (it was in many newspapers in Spain)(:
http://www.hispanidad.com/noticia.aspx?ID=134276


From PD website in Spain -
“This is the latest information that we control the company MSD”

Letter from Merck (MSD) in response:

Parkinson Association TARAY
Mr. D. Francisco Fernandez
Vice - Presidente
Asociación Nacional Parkinson TARAY
Manuel Serrano, 23
28300 Aranjuez (Madrid)

February 21, 2010

Dear Mr. Fernandez:

I am writing to inform you that thanks to the quick intervention of the Spanish Agency of Medicines and Health Products (AEMPS) belonging to the Ministry of Health and Social Policy, which has been evaluated with the highest priority the proposed new manufacturer for the active ingredient levodopa our product for Parkinson's disease Sinemet ® (carbidopa-Ievodopa), this manufacturer has been approved and we have begun to produce the active ingredient.

This good news will resolve partial or limited availability of
Sinemet previously announced in our country until 2011. Obtaining this
allow health approval in mid-March this year to start
levodopa product manufactured from the new source of supply.

As for the situation today and until you start available
medicine for the new manufacturer, we inform that standardization has been achieved thanks to divert supply to our country medicine from other countries in the European Union, although problems can still occur in submitting timely supply of Sinemet 25/100 mg PLUS until the situation has returned completely at the end of March.

We remind that in our country there are now other drugs
available with the same composition, exchangeable for the pharmacist, and patients may also consult with their doctors about these alternative treatments available in our country.

We will keep you informed about the full normalization of supply
product when we have new information during the month of March. Do not hesitate to contact us by phone for any clarification 913210843 relevant.

Sincerely,

Carmen Lopez-Lavid
Communications Director, MDS

In Spanish, (near the bottom of the front page):
http://www.aep-taray.org/portal/

Thanks, this is what I meant by actual evidence of shortage.
Without this being tracked globally we have no way of either
understanding what is really happening or, approaching
people who are able to bring this to light with hard facts.

However it is shameful that it is patient voices that are leading
the way that an essential drug is being shunted around.

Lindy

As I alluded to in my reply, the most likely reason this is being so hush-hush is they don't want patients to start stocking up. If we did, and the hypohesis that something new is coming out, the company won't get the record-breaking sells they anticipate (which also means the "new" drug won't be generic for several years). This is purely speculative, but if I was a bettin' man . . . er . . . woman . . . blah, blah, blah.

Peg

Francisco Fernández Cimas
Vicepresidente
Asociación Nacional Parkinson TARAY

Muchas gracias
Usted es un héroe.
Usted es el primer líder de Parkinson para levantarse y hablar.
Le doy las gracias por su valentía.

Bob Dawson