Reminyl renamed Razadyne in U.S. to support patient safety
Drug News -- April 11, 2005
Reminyl renamed Razadyne in U.S. to support patient safety
TITUSVILLE, N.J., April 11, 2005 -- Ortho-McNeil Neurologics announced that Reminyl (galantamine hydrobromide) will now be marketed in the U.S. under the new product trade name Razadyne (galantamine hydrobromide). The extended release formulation of galantamine, approved in December 2004, will be marketed as Razadyne ER. The products are indicated for the treatment of the symptoms of mild to moderate Alzheimer's disease.
The name is being changed to help avoid confusion with the diabetes drug Amaryl (glimepiride), which is marketed by Sanofi-Aventis. Ortho-McNeil Neurologics began working closely with the FDA after learning of several reports of prescribing and dispensing errors resulting from confusion between Reminyl and Amaryl.
"Our top priority is to ensure the well-being of our patients," said Joseph Hulihan, M.D., vice president, Medical Affairs, Ortho-McNeil Neurologics, Inc. "Through ongoing discussions with the FDA, 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."
To raise awareness and educate prescribers, pharmacists, patients and their caregivers about the potential for confusion related to the names of the products, the company launched a comprehensive communications campaign last October. This campaign featured a variety of elements, including letters to healthcare professionals, journal advertising, pharmacist education, outreach to professional medical societies and disease-related consumer advocacy organizations, and a brochure for caregivers of patients with Alzheimer's disease.
"Medication errors occur frequently among elderly patients, and the need for clarity in product names is particularly important for patients with Alzheimer's disease and their caregivers," said Stephen Aronson, M.D., clinical assistant professor, University of Michigan Medical School. "I believe this change is key to keeping safety at the forefront for my patients."
Approximately two million patients have been treated with Reminyl to date. According to reports submitted to the FDA and the U.S. Pharmacopoeia since Reminyl was introduced in the United States, 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 patients with Alzheimer's disease who did not have diabetes mellitus resulted in serious events, including severe hypoglycemia and -- in two cases -- death.
The immediate release formulation bearing the new name, Razadyne, will be available in pharmacies from July 2005. Prescriptions written before that time will be filled with Reminyl. Product bearing the new name, Razadyne ER, the extended release formulation, will be available in pharmacies beginning in mid-May 2005. To inform healthcare professionals, patients and caregivers about the product name change, the company will continue its aggressive communications campaign.
In clinical trials, the most frequent adverse events with Razadyne ER were similar to those seen with Razadyne. The most common side effects are nausea, vomiting, diarrhea, loss of appetite, and weight loss. Typically, these side effects are mild and temporary. Razadyne may not be for everyone. Some people experience a slowed heart rate, which may lead to fainting. Serious stomach problems can occur in people taking medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) or those at risk for stomach ulcers. See www.Razadyne.com for full prescribing information.
Patients, caregivers and healthcare professionals with concerns about or reports of medication errors related to Reminyl and Amaryl, or with questions about Razadyne, should contact Ortho-McNeil Neurologics directly at 1-800-526-7736. Additional information is available online at www.Razadyne.com
Source: Ortho-McNeil Neurologics
Pharma Industry News Archive
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
