McLean wrote:

>You are probably aware that generic selegiline hydrochloride tablets
>are now available. While the lower cost of these generics may seem
>appealing, there are no real substitutes for Eldepryl® (selegiline
>hydrochloride) Capsules, and the price you may pay in controlling your
>PD may be higher than you think. At a recent conference in Tampa,
>Florida, eight PD experts met to discuss this important issue. Here's a
>summary of what they found.

>Generic selegiline tablets were not approved for use by the Food and
>Drug Administration using the same criteria required for brand name
>Eldepryl. First, these generic tablets were tested only in a small
>number of healthy volunteers who didn't have PD.

             Generics drugs are normally not tested like the original.
The brand drug is the standard by which the generics have to conform and
they are examined and tested rigorously biologically and chemically.
The 'experts' do not mention whether or not  the 'standard' was tested
on PD volunteers and the number of volunteers.  That info is in the
approval document.

>Second, the generic companies were not required to confirm that their
>products were bioequivalent with Eldepryl® (selegiline hydrochloride)
>Capsules. This means the companies did not have to show that their
>tablets are absorbed into the bloodstream at the same rate or to the
>same extent as your Eldepryl Capsules.

              Blood levels are not normally tested with generics because
it would become too ponderous to get volunteers for hundreds of tests.
The sponsor of the original drug is responsible for testing the
pharmaceutical and pharmacological properties of the product.
Bioequivalence is assumed and determined by comparing the dissolution
properties of the generics to those of the standard.

>This is very important because after you take an Eldepryl® (selegiline
>hydrochloride) Capsule it's mostly broken down by chemical substances
>in your body until a certain amount of active medicine reaches your
>bloodstream.  Then, that medicine travels to your brain, where it works
>along with your Sinemet®* (carbidopa/levodopa) to control your PD.
>Your doctor has worked very carefully to make sure that you take just
>the right amount of Sinemet, so that when the active medicine from your
>Eldepryl Capsules reaches your brain, the effect is just right.

>The truth is, if you switch to generic selegiline tablets, the amount
>of medicine that reaches your brain may be different from what you
>currently get from Eldepryl® (selegiline hydrochloride) Capsules, and
>because generic tablets are interchangeable, your medicine may even
>differ from month to month when receiving different generics. So any
>switching can mean problems. If the amount of active medicine your
>brain receives is too high, you can experience random movements,
>nausea, vomiting, hallucinations, and heart pounding. If it's too low,
>your Sinemet will not work as well. This means your symptoms can get
>worse and you may be more likely to lose your balance and fall.

>The experts agree: Despite the cost savings, generic selegiline tablets
>may not be worth it. You may be able to save some money, but what you
>can lose in terms of controlling your PD could be a much higher price
>to pay.

              Sponsor of generic products must submit documentation
showing that they are chemically and physically similar to the
original.  Differences may occur due to a different formulation of
excipients like talc, starch, sugar, etc. , or difference in the
pressure applied in tabletting the mixtures.
               Also to be noted is that the experts mentioned blood
levels before but the important part is that amount that reached the
brain, and that is quasi impossible to determine because it is affected
by a great many variables like the type and quantity of  food ingested
before, during, or after the drug.
                 I have a feeling that the company is just using scare
tactics to keep you from buying elsewhere.  You should be able to
discuss this with your movement disorder specialist, and you might also
inquire from the generic company to show evidence of comparability. The
experts may well be working with Somerset Pharmaceuticals  in Tampa.  I
would likely ask for a report of that conference.

Michel Margosis