SAD NEWS FOR 4-AP Users

We were visited by an inspector from the Illinois Department of Regulations on Friday, May 21, 2004. After inspecting our records and facilities all was found to be in order. However, we did receive a surprise. It seems that someone had filed a complaint about us dispensing 4-aminopyridine (4-AP). The complaining person stated that 4-AP is not an FDA approved and the investigator suggested strongly that we stop dispensing it – immediately. She did not give us a direct order but it is clear that we must stop dispensing 4-AP at once.

Sadly, this will have a negative impact on patients and prescribers. Many users of 4-AP have experienced significant improvement in their conditions. Yet, there is no published scientific evidence that 4-AP does what so many users know. That, coupled with the lack of FDA approval – and the complaint – place us in the unpopular position of no longer being able to fill prescriptions for 4-AP.

This change takes effect immediately.

I have determined that our pharmacy has been singled out. We received a call prior to the inspector's visit asking questions about whether we makde 4-AP. I remember that the caller seemed very knowledgeable about the issue. Our inspector told me that she had visited us and taken action as the result of a complaint filed against us by an unknown person who claimed that we were makeing 4-AP and that it was not an approved FDA drug. I think I know who initiated the complaint, but I don't hve sufficient evience to actually make a claim or name ther person.

Other compounders in Illinois can still make 4-AP under the orders of a doctor. I called our state board and asked what I could do about the discrepancy - that I can't sell the preparation while everyone else can.  I was told to supply the names of the pharmacies that were still making it and his office would see to it that everyone I reported would be stopped. This is heavy handed and to file a complaint about other compounders woul;d deny our local patients access to this important treatment. I did not turn over any other compounder. It still makes me angry that someone filed a complaint that caused us to stop serving many of our patients..

What can anyone do about this? I’m not certain. The “facts” about the benefits of 4-AP are mostly anecdotal. Just because someone believes it helps their symptoms does not mean it will necessarily meet scientific criteria. In order for this helpful product to receive FDA approval it will need to be officially studied and an application will need to be made to the FDA. That is a time-consuming and costly process. One drug company (Acorda) has been in the process for years. While there have been promises of a commercial product for years (Fampridine) none has actually been introduced.

Sadly, we will comply with the inspector’s strong suggestion. Prescriptions for 4-AP are no longer filled at The Compounder pharmacy.

Sincerely,
Larry J. Frieders
Compounding Pharmacist

LOOKING FOR A COMPOUNDER? Try This. You can contact the International Academy of Compounding pharmacists.  Provide your ZIP code and they will give you the names of compounding pharmacists you can call.  Ask the pharmacist for the names of practitioners they work with in your area.

The International Academy of Compounding Pharmacists

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