Special to Alzheimer's Weekly
Published Week of
August 26 - September 1, 2007

Exelon is OK. The literature healthcare professionals get from its manufacturer is not.

In a warning letter from the FDA, pharmaceutical giant Novartis was told to immediately fix Exelon’s misleading literature for healthcare professionals. The half-a-billion-dollar-a-year Exelon has been proven effective in treating symptoms of mild-to-moderate Alzheimer's. The FDA has no problem with the medicine itself. Rather, they are genuinely concerned that the existing literature can mislead professionals prescribing and administering Exelon.

The FDA says Exelon’s file card to professionals wrongly implies Exelon has been proven to
1.         be more effective than Aricept
2.         reduce Alzheimer’s behaviors such as aggression and hallucinations
3.         have few significant risks or side effects
4.         be safe and effective when combined with Namenda.

This does not mean anyone taking Exelon or considering it should not. It does imply you should go over these issues with your doctor as soon as possible.

In the letter, the FDA takes Novartis to task for misbranding Exelon in violation of the Federal Food, Drug and Cosmetic Act as well as FDA implementing regulations. Serious claims, indeed.

“These violations are concerning from a public health perspective because they suggest that Exelon is safer or more effective than has been demonstrated, and they encourage the use of Exelon in circumstances other than those for which the drug has been shown to be safe and effective,” wrote Tom Abrams, head of the FDA’s Division of Drug Marketing, Advertising and Communications, in his letter to Alex Gorsky, head of Novartis in the U.S.

For example, the Exelon file card claims that in a trial of people with moderate Alzheimer’s, Exelon:

1. “Significantly reduced aggression at 26 weeks.”
2. “Reduced hallucinations and affective disturbances, diurnal rhythm, and activity disturbances after 26 weeks.”

The FDA explains in a lengthy paragraph why this trial is simply “not credible.”

Next, the FDA points out the dangers of literature like this when prescribing medicines. Using technical language, the literature states Exelon has no pharmacokinetic drug-drug interactions, making it safe to take with medications like fluoxetine, warfarin and digoxin. The literature SHOULD have also added in the same place that there ARE risks of using Exelon with anticholinergics, cholinomimetics, and other cholinesterase inhibitors. Says the FDA, “The file card misleadingly suggests that Exelon is safer than has been demonstrated by substantial evidence or substantial clinical experience.”

In a final blow, the FDA criticizes the literature’s discussion of using Exelon with Namenda, a highly popular medicine for Alzheimer's that is sometimes used in conjunction with other medicines such as Aricept. The FDA states that Exelon's literature “is misleading because the combination of Exelon and Namenda has not been proven to be safe and effective for the treatment of Alzheimer’s Disease. These products are not indicated for use together as combination therapy; in fact, they are not indicated for the same patient populations (Exelon is indicated for mild to moderate dementia of the Alzheimer’s type, while Namenda is indicated for moderate to severe dementia of the Alzheimer’s type).”

This week, the FDA is expecting to receive from Novartis a “plan of action to disseminate truthful, non-misleading and complete corrective messages.”

According to a report in Reuters, Novartis spokeswoman Christine Cascio said the company was reviewing the FDA letter and would respond by the date requested by the agency. Cascio indicated that Novartis will "take the necessary steps to ensure that all of our promotional materials are in full compliance with FDA regulations."

Once Novartis fixes the problem, the picture should be clear for new users of Exelon.

In the meantime, if you are in the midst of taking or considering Exelon, or caring for someone who is, be sure to bring this information to the attention of your doctor or healthcare professional.

Links to More Information:

A complete copy of the FDA’s letter to Novartis regarding the Exelon professional file card

Exelon's Professional File Card

FDA Division of Drug Marketing, Advertising and Communications - Mission: "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated."

Related article in Alzheimer's Weekly:
FDA Approves Exelon®Patch, The First Skin Patch for Alzheimer’s Disease

Exelon's Web Site 

Novartis Pharmaceuticals U.S.A.

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