Ortho-McNeil Neurologics Inc., a division of Johnson and Johnson Inc.,
announced last month that it has completed a "re-branding" of the
acetyl-cholinesterase inhibitor galantamine hydrobromide. The medication,
originally branded as Reminyl, will now be marketed as Razadyne. The
extended-release formulation is Razadyne ER.
The company initiated the name change in October 2004 after FDA safety
officials voiced concerns regarding several reports of prescribing and
dispensing errors between Reminyl and a similarly named drug, Amaryl
Galantamine is indicated for the treatment of mild to moderate Alzheimer's
disease, while glimepiride is indicated for the treatment of diabetes.
Glimepiride is marketed by Sanofi-Aventis (Psychiatric News, December
The FDA approved the immediate-release formulation of galantamine in
February 2001, and the extended-release formulation in December 2004.
According to Ortho-McNeil, about 2 million patients have been treated with
galantamine. According to drug adverseevent reports submitted to the FDA and
the U.S. Pharmacopoeia, a few prescriptions for Reminyl have been incorrectly
written, interpreted, labeled, or filled, leading to confusion between Reminyl
and Amaryl. The accidental administration of Amaryl to Alzheimer's patients
who did not have diabetes mellitus resulted in serious events, including
severe hypoglycemia and, in two cases, death.
"Through ongoing discussions with the FDA," said Joseph
Hulihan, M.D., vice president of medical affairs at Ortho-McNeil Neurologics
Inc., in a prepared statement, "we agreed that the best way to avoid
future dispensing errors was to change the name of Reminyl, which came onto
the market nearly six years after Amaryl."
Razadyne ER will be available in pharmacies sometime this month, and the
immediate-release formulation will be available beginning in July.
Psychiatrists and others with concerns or reports of medication errors
related to Reminyl and Amaryl should contact Ortho-McNeil Neurologics Inc. at
(800) 526-7736, the company said.
Additional information is posted online at<www.RAZADYNE.com>.▪