received from NPF today:
Merck & Co. Inc. has informed the Parkinson's disease community that in early 2011, there may be a potential temporary supply shortage in the U.S. for SINEMET® (carbidopa-levodopa) and SINEMET CR® (carbidopa-levodopa controlled release tablets).

While there is currently no shortage, it is advisable to speak with your health care provider about appropriate steps should a shortage occur. Your health care provider can give you relevant information about potential short-term alternative therapies, including the availability of alternative generic equivalents.

The FDA has shown generic SINEMET® to be effective against the symptoms of Parkinson's disease, but dosing may need to be slightly adjusted due to differences in manufacturing and formulation. Should you need to temporarily switch to a generic version of SINEMET®, be aware that some people may experience a change in how the medication works. If you do experience a change, contact your health care provider who may prescribe a different dose or timing regimen.

Patients, caregivers and health care professionals in the U.S. who have more questions about the availability of SINEMET® can contact the Merck National Service Center at 1-800-NSC-MERCK.

NPF is committed to keeping you informed of developments on this issue. We will alert you if we get any more information about either a shortage developing or the crisis being averted. If you are informed by your doctor or pharmacist that SINEMET® is not available in your area, please contact us at 1-800-4PD-INFO (473-4636) or helpline@parkinson.org. If you have any questions, Dr. Okun is prepared to address issues about the shortage and generic substitution on our Ask the Doc online discussion forum.

National Parkinson Foundation



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HOW LOUD AND MAD ARE WE GOING TO GET?

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HOW LOUD AND MAD ARE WE GOING TO GET?[/QUOTE]

I can hardly believe it. And last February, FDA said it wasn't an issue here. Oh well it's 2011.

Do we yet know why there's this roving shortage world wide?

katherine

I can hardly believe it. And last February, FDA said it wasn't an issue here. Oh well it's 2011.

Do we yet know why there's this roving shortage world wide?

katherine[/quote]

katherine,

Pharmaceuticals don't seem to think they owe anyone honest explanations. This is where our orgs are going to prove who they are really loyal to iMHO There are enough of them. The explanation thus far outside the U.S. has been about switching manufacturers and a shortage of materials. Also said it was needed more in other countries.

I often think of the relief and gratitude on the face of an advocate in the UK when I gave her a full bottle of CR - generic. The shortage didn't just include name brand.

Merck (MSD) has been incredibly cagy about why this world wide shortage has occurred. My last prescription here in the UK was filled with Sinemet from 3 different sources, and though I know they are SUPPOSED to work the same, there ARE differences....... just as with moving to generics.... I have forwarded this to the person who led the campaign to get some answers here.

Wasn't there also recently a notification about a pending shortage of many drugs in the US ? This happened in the UK too......... there is a pattern emerging.

Lindy

Thanks Paula,

Thank you NPF for getting this important news out to the PD community and promising to keep us informed. There is a link to their press releases at
http://www.parkinson.org/About-Us/Pr...-Shortage-of-S

On a PAN conference call I heard that the potential shortage was casued by Merck becoming the US distributor for Sinemet – as they are in Europe. T he FDA has to approve their facilities, and that might delay a smooth transition, however it was also stated that the FDA was on track to complete the approval. In a timely manner And generic sinemet should be available. But as we know it doesn’ work as well as the brand name version for some PWP and many of our sisters and brothers outside the US suffered during last year’s “shortages.

At least in the current situation there has been an attempt to communicate with PWP thru some of the orgs. But is that enough? With about a zillion PD orgs in the US , couldn’t they do more by joining together. -- standing up for the patients and seeking ways to lessen the impact, and maybe even prevent future shortages. If the entire PD community “got tough” with Merck and facilitated 2 way communication, couldn’t that make a difference? At the very least every PD org could highlight the shortage on their home pages.

We could monitor the FDA , checking that all required approvals are moving ahead as quickly as possible.

We should learn from the past. If the entire PD community in the uS gets involved this time – it could make Merck and other Pharma companies more responsive. It doesn’t matter which org or patient group leads it -- someone just please do it!!