Medication Errors Between RAZADYNE^® (galantamine hydrobromide) and Rozerem™ (ramelteon)

March 13, 2006 - There have been reports of name confusion between RAZADYNE, a treatment for the symptoms of mild to moderate Alzheimer’s disease marketed by Ortho-McNeil Neurologics, Inc. and Rozerem, a medication for the treatment of insomnia marketed by Takeda Pharmaceuticals America, Inc.

We are committed to patient safety at Ortho-McNeil Neurologics, Inc. Although no serious adverse events have been reported to date, we encourage you to consider the following simple precautions to help prevent confusion and minimize the potential for medication errors:

Physicians are urged to:

• Be alert to the possibility of medication errors in patients prescribed RAZADYNE or Rozerem;
• Be aware of the possibility of medication errors in patients presenting with unexpected signs or symptoms while on RAZADYNE or Rozerem;
• Confirm the brand and generic names and dosage prescribed on written and oral prescriptions;
• Print legible prescriptions that include the brand and generic names, with indication;
• Counsel patients about the brand and generic names, indications and proper use of each medication.

Pharmacists are urged to:

• Be particularly cautious when dispensing these products both medications have a starting dose of 8 mg, and confirm the brand and generic names prescribed on written and oral prescriptions;
• Place RAZADYNE and Rozerem notably apart from one another on the stock shelf;
• Confirm the brand and generic names when communicating the drug names within the pharmacy;
• Communicate oral prescriptions clearly and write full and legible prescriptions for RAZADYNE and Rozerem;
• Counsel patients about the brand and generic names, indications and proper use of each medication.

Patients and Caregivers are urged to:

• Get printed information about the medication from the pharmacist when picking up a RAZADYNE or Rozerem prescription;
• Become better informed about personal medications – know the brand and generic names of each medication, what the medications look like and what side effects they may experience;
• Verify the information with the pharmacist before your medication is dispensed;
• Look at the medication before you take it – if it does not look like what you usually take, contact a healthcare professional before you take the drug to find out why;
• Keep medications in the original, labeled containers because this can help identify each pill and follow proper directions;
• Ask a healthcare professional for more information if you have any questions about medications, including the benefits and risks.

If you have additional questions about RAZADYNE, please visit www.RAZADYNE.com or contact Customer Communications at 1-800-526-7736 (9 AM to 5 PM EST, Mon-Fri). 

Healthcare professionals who become aware of any medication errors involving RAZADYNE are urged to report them immediately to Ortho-McNeil Neurologics, Inc. at 1-800-682-6532, and if Rozerem is involved, also to Takeda Pharmaceuticals at 1-877-825-3327. Medication errors should also be reported to the FDA’s MedWatch Adverse Event Reporting Program (1-800-FDA-1088) and the USP Medication Error Reporting Program in cooperation with the Institute for Safe Medication Practices (1-800-23ERROR;1-800-FAIL-SAF).

Safety Considerations
Most frequent adverse events: In clinical trials, the most frequent adverse events with RAZADYNE® ER were similar to those seen with RAZADYNE®. The most frequent adverse events that occurred with RAZADYNE were nausea, vomiting, diarrhea, anorexia, and weight loss.

Anesthesia: Cholinesterase inhibitors, such as galantamine, are likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

Cardiovascular events: Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular (AV) nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with supraventricular cardiac conduction disorders or to patients taking other drugs concomitantly that significantly slow heart rate. In clinical trials, galantamine was associated with more frequent reports of bradycardia and syncope vs placebo.

Gastrointestinal: Cholinesterase inhibitors may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk of developing ulcers, eg, those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs.

Genitourinary: Cholinesterase inhibitors may cause bladder outflow obstruction.

Neurological conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. In clinical trials, there was no increase in the incidence of convulsions with galantamine compared with placebo.

Pulmonary conditions: Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

Hepatic & Renal Impairment: In patients with moderately impaired hepatic or renal function, dose titration should proceed cautiously. The use of RAZADYNE in patients with severe hepatic impairment or severely impaired renal function (CLcr < 9 mL/min) is not recommended.

Deaths in Subjects with Mild Cognitive Impairment (MCI): In controlled trials in elderly subjects with mild cognitive impairment (MCI), 13 subjects on RAZADYNE (n=1026) and 1 on placebo (n=1022) died of various causes. About half of the RAZADYNE deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). RAZADYNE is not indicated for the treatment of MCI.

For more information, read the full US Prescribing Information by clicking here.