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Potentially Dangerous Alzheimer's Medicine Sold As Supplement

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Potentially Dangerous Alzheimer's Medicine Sold As Supplement FDA Issued Warning Letter To Company

POSTED: 6:58 pm CDT October 26, 2005 UPDATED: 7:15 pm CDT October 26, 2005

HOUSTON -- A medicine prescribed to Alzheimer's patients that comes with a warning can also be purchased over the counter, but without a warning label, KPRC Local 2 reported Wednesday.

Recently, 13 Alzheimer patients taking the prescription drug Razadyne, formerly known as Reminyl, died.

The unexpected deaths prompted the Food and Drug Administration to issue a warning label for the drug to alert consumers of a potential danger.

"There are dangers to the drug. There are some potentially hazardous side effects such as cardiac problems, slow heartbeat and even stoppage of the heart," a neurologist said.

But the same drug can be found without a prescription, Local 2 reported.

The station found the same medication as on over-the-counter supplement called galantamine and ordered it.

"Isn't this the same medicine, galantamine?" the station asked.

"Absolutely," the doctor said.

The supplement GalantaMind's active ingredient is galantamine hydrobromide, which is the same active ingredients as the prescription drug, Razadyne.

The FDA approved it in 2001 for treatment of Alzheimer's as a prescription drug and then learned that a nutritional company was selling the same medication as an over-the-counter supplement.

KPRC uncovered a letter from the FDA warning the company to cease and desist.

The letter said, "Your product has the potential to cause serious and life-threatening adverse events. The labeling for 'GalantaMind' provides virtually no information about the risks."

The FDA did not answer KPRC's inquires, so the station contacted the manufacturer, who told them that they are allowed to sell the product under a grandfather clause of a U.S. law passed in 1994.

Though the supplement variety is being sold legally from what the station could determine, the FDA, under its own rules, has a duty to warn the public about problems with medicines and supplements -- especially ones that it is aware of.

Anyone using galantamine in the supplement variety is urged to contact a physician immediately to discuss the appropriateness and safety implications.