TITUSVILLE, N.J., Sept. 27 /PRNewswire/ -- Ortho-McNeil Neurologics, Inc. is launching an educational campaign to alert healthcare professionals to the potential for medication errors between its product, TOPAMAX(R) (topiramate) tablets and TOPROL-XL(R)* (metroprolol succinate) extended-release tablets.
TOPAMAX is approved by the U.S. Food and Drug Administration (FDA) for epilepsy treatment and migraine prevention, and is marketed by Ortho-McNeil Neurologics, Inc. TOPROL-XL is a beta-blocker approved to treat high blood pressure, angina and heart failure, and is marketed by AstraZeneca LP.
Reports of patients receiving TOPAMAX instead of TOPROL-XL, or vice versa, have been submitted to the FDA and other health authorities. These reports document prescriptions for TOPAMAX and TOPROL-XL that have been incorrectly written, interpreted, labeled and/or dispensed, leading to patients getting the wrong medication.
Patients who receive incorrect medications risk experiencing potentially serious health consequences that are associated with either unintended exposure to a medication or the lack of a needed therapy. For example, patients with epilepsy who are on TOPAMAX therapy can experience seizures or increased seizure frequency if TOPAMAX therapy is interrupted. Patients with ischemic heart disease on TOPROL-XL can experience angina or myocardial infarction if TOPROL-XL therapy is abruptly interrupted.
"Patient safety is our top priority," said Joseph Hulihan, M.D., Vice President, Medical Affairs, Ortho-McNeil Neurologics, Inc. "Healthcare professionals play a pivotal role in clearly communicating oral and written prescriptions, and verifying and accurately dispensing prescriptions to ensure that all patients receive their intended medications."
The Ortho-McNeil Neurologics, Inc. communications campaign will include a letter to healthcare professionals nationwide, recommendations to drug information database providers to establish computer "pop-up" alerts, pharmacy shelf-talkers, and direct contact with national pharmacy chains and national and state pharmacy boards and associations. Comprehensive educational information on the topic is also available on company-sponsored Web sites, http://www.rxforsafety.com , http://www.topamax.com , and http://www.topamax-epilepsy.com .
Ortho-McNeil Neurologics, Inc. also offers the following tips:
Physicians are urged to:
-- Be alert to the possibility of medication errors in patients
prescribed TOPAMAX or TOPROL-XL;
-- Be aware of the possibility of medication errors in patients
presenting with unexpected signs or symptoms while on TOPAMAX or
-- Confirm the brand and generic names and dosage prescribed on written
and oral prescriptions;
-- Print legible prescriptions that include the brand and generic names,
-- Counsel patients about the brand name, indication and proper use of
Pharmacists are urged to:
-- Place TOPAMAX and TOPROL-XL apart from one another on the stock
-- Place the shelf-talker provided in the Dear Pharmacist communication
on the stock shelf;
-- Confirm the brand and generic names prescribed on written and oral
-- Confirm the brand and generic names when communicating the drug names
within the pharmacy;
-- Write full and legible prescriptions for these products and
communicate oral prescriptions clearly;
-- Counsel patients about the brand name, indication and proper use of
Drug database content providers are urged to:
-- Install sound-alike/look-alike name alert warnings for the name pair
confusion with TOPAMAX and TOPROL-XL;
-- Use "tall man" lettering to highlight the end of each name (e.g.,
topAMAX and TOPROL-XL);
-- Avoid the use of confusing or non-distinguishing drug mnemonics such
-- Use brand and generic names when communicating the drug names.
Patients are urged to:
-- Get printed information about the medication from the pharmacist when
picking up their TOPAMAX or TOPROL-XL prescription;
-- Become better informed about their medications - know the brand name
of each medication, what the medications look like and what side
effects they may experience;
-- Look at the medication before they take it - if it does not look like
what they usually take, patients should contact their healthcare
professional before they take the drug to find out why;
-- Keep medications in the original, labeled containers because this can
help them identify each pill and follow proper directions;
-- Ask their healthcare professional for more information if they have
any questions about their medications, including the benefits and
Healthcare professionals who become aware of any medication errors involving TOPAMAX are urged to report them immediately to Ortho-McNeil Neurologics, Inc. at 1-800-682-6532, and if TOPROL-XL is involved, also to AstraZeneca at 1-800-236-9933. 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).
TOPAMAX is indicated as initial monotherapy in adults and children 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than two seizures in the three months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. TOPAMAX is indicated as adjunctive therapy for adults and pediatric patients ages 2 - 16 years with partial-onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. TOPAMAX is also indicated for prophylaxis of migraine headache in adults only. TOPAMAX has not been studied for acute treatment of migraine.
TOPROL-XL(R) is indicated to treat hypertension as monotherapy or in combination with other antihypertensive agents, long-term treatment of angina pectoris, and heart failure NYHA Class II or III. TOPROL-XL has a boxed warning against abrupt cessation of therapy. Patients with ischemic heart disease who are on TOPROL-XL can experience angina or myocardial infarction if TOPROL-XL therapy is abruptly interrupted.
TOPAMAX Important Safety Information for Migraine
TOPAMAX is contraindicated in patients with a history of hypersensitivity to any component of this product.
TOPAMAX has been associated with serious adverse events, including: hyperchloremic, non-anion gap metabolic acidosis-lowering of bicarbonate levels in the blood. Measurement of baseline and periodic serum bicarbonate is recommended. Acute myopia and secondary angle closure glaucoma patients should be cautioned to seek medical attention if they experience blurred vision or ocular pain. Oligohidrosis and hyperthermia-decreased sweating and increased body temperature, especially in hot weather. The majority of reports have been in children. Cognitive/psychiatric side effects, including cognitive dysfunction, psychiatric/behavioral disturbances, and somnolence and fatigue. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with TOPAMAX. Patients should be instructed to maintain an adequate fluid intake in order to minimize the risk of renal stone formation.
In addition, the most common adverse events associated with TOPAMAX 100 mg vs placebo were: paresthesia, 51% vs 6%; anorexia, 15% vs 6%; fatigue, 15% vs 11%; nausea, 13% vs 8%; diarrhea, 11% vs 4%; weight decrease, 9% vs 1%; taste alteration, 8% vs 1%.
Please see full U.S. Prescribing Information at http://www.topamax.com or call 1-800-682-6532 for more information.
TOPAMAX Important Safety Information for Epilepsy
TOPAMAX has been associated with serious adverse events, including: hyperchloremic, non-anion gap metabolic acidosis (lowering of serum bicarbonate levels)-measurement of baseline and periodic serum bicarbonate levels is recommended; acute myopia and secondary angle closure glaucoma patients should seek medical attention if they experience blurred vision or ocular pain; oligohidrosis and hyperthermia occur most often in hot weather and in children; cognitive/psychiatric side effects, including somnolence and fatigue, cognitive dysfunction, and psychiatric/behavioral disturbances; hyperammonemia with or without encephalopathy associated with the concomitant use of valproic acid; and kidney stones patients should maintain an adequate fluid intake to minimize the risk of renal stone formation. In women taking combination oral contraceptives with TOPAMAX, a significant decrease in estrogen exposure has been shown at TOPAMAX doses .200 mg/day. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered.
As monotherapy, the most common side effects of TOPAMAX (in the 400 mg/day group and at a rate higher than the 50 mg/day group) in adults were: paresthesia, weight decrease, somnolence, anorexia, dizziness, and difficulty with memory; and in children: weight decrease, upper respiratory tract infection, paresthesia, anorexia, diarrhea, and mood problems.
In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX in adults (200 to 400 mg/day) were somnolence, dizziness, nervousness, ataxia, fatigue, speech disorders and related problems, psychomotor slowing, abnormal vision, difficulty with memory, paresthesia, and diplopia; and in children (5 to 9 mg/kg/day), fatigue, somnolence, anorexia, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease.
For more information, read the full U.S. Prescribing Information, upon request by calling 1-800-682-6532 or by visiting http://www.topamax-epilepsy.com or http://www.orthomcneilneurologics.com .
Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Inc. focuses exclusively on providing solutions that improve neurological health. The company currently markets products for Alzheimer's disease, epilepsy, and acute and preventive migraine treatment. Ortho-McNeil Neurologics, in conjunction with internal and external research partners, continues to explore new opportunities to develop solutions for unmet healthcare needs in neurology.
* TOPROL-XL is a registered trademark of the AstraZeneca group of
Contact: Kassy McGourty
Ortho-McNeil Neurologics, Inc.