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 NUTLEY, N.J., Aug. 4 /PRNewswire/ -- Roche Laboratories, a division of Hoffmann-La Roche Inc., today announced that Romazicon(TM) I.V. (flumazenil 0.1 mg/mL) is the new name of its benzodiazepine antagonist (formerly known as Mazicon(TM)).
 An injectable solution, Romazicon is indicated for rapid reversal of the sedative effects of benzodiazepines, which are used for conscious sedation or as part of general anesthesia for an estimated 31 million surgical, diagnostic and therapeutic procedures annually.
 "Changing the brand name of an established medication is always a difficult decision," said Bruce Medd, M.D., associate vice president and director of Professional Services at Roche. "We felt it was necessary because some healthcare professionals had expressed the opinion that our benzodiazepine antagonist might be confused with Mivacron(R) (mivacurium chloride), a short-acting, neuromuscular blocking agent. Although there have been no reports of patients receiving one drug when the other was intended, we determined that a proactive approach was in the best interests of both patients and physicians."
 The Institute for Safe Medication Practices, Inc. (ISMP), a public health advocacy group that monitors for prescription errors, responded to the proactive name change by urging all manufacturers, providers and regulators to collaborate in finding ways to prevent medication errors. "We estimate that each year more than 1,000 people die in hospitals unnecessarily due to medication errors, and thousands more are seriously injured," said Michael R. Cohen, MS, FASHP, president of ISMP.
 "Before a single accident was ever reported, Roche listened to concerns of medical professionals and made the name change. This action clearly demonstrates the Roche commitment to patient safety," said ISMP cofounders Mr. Cohen and Neil M. Davis, PharmD, FASHP.
 Unique Therapeutic Category
 Romazicon is part of a unique therapeutic category, and is the only drug in its class. The medication works by inhibiting the effect of benzodiazepines at the brain's receptor sites. Because this mechanism of action is so specific, Romazicon is able to selectively reverse only the sedative effects of benzodiazepines without interfering with the central nervous system effects of other perioperative medications such as barbiturates, analgesics and/or narcotics given for pain relief.
 "The availability of an effective benzodiazepine antagonist extends a high degree of control to the anesthesiologist," said Paul White, M.D., professor and McDermott Chair of Anesthesiology, University of Texas Southwestern Medical Center. "It allows us to more effectively control the role of recovery from commonly used benzodiazepine sedative drugs. It is now possible to take advantage of the smooth quality of sedation, anterograde amnesia, hemodynamic stability and low incidence of postprocedural vomiting associated with benzodiazepines, yet restore alertness promptly upon completion of the procedure if needed." Romazicon allows the anesthesiologist to restore consciousness rapidly and smoothly. By titrating the medication, benzodiazepine sedation is alleviated and the patient is awake yet calm.
 A pulmonary patient treated with Romazicon, for example, is able to respond to the physician's instructions to participate in deep breathing, to cough and to talk. A neurosurgical patient can respond to requests to move his toes and/or hands. The physician gains essential information about outcome much more efficiently.
 Safety Profile
 Clinical trials show that Romazicon is generally well tolerated by patients. The most common minor side effects are nausea and/or vomiting. Others include: dizziness, agitation, pain or reaction at the injection site, headache and emotional lability.
 Romazicon is contraindicated in certain patients in whom antagonism of the benzodiazepine has been associated with the occurrence of seizures. To date, an estimated 560,000 patients have received Romazicon since its launch in the U.S. During that time only ten cases of seizures have been reported to the company, representing a fraction of the U.S. patient group. Those at-risk patients are chronic benzodiazepine users or abusers (who may also experience acute benzodiazepine withdrawal); patients with underlying seizure activity controlled by a benzodiazepine; patients exhibiting signs of concurrent major sedative hypnotic withdrawal or cyclic antidepressant poisoning.
 Romazicon is contraindicated in patients showing signs of serious cyclic antidepressant overdose, patients who receive benzodiazepines to control potentially life-threatening conditions and patients hypersensitive to benzodiazepines or flumazenil.
 Romazicon was first introduced into clinical practice in Switzerland in 1987 by F. Hoffmann-La Roche Ltd. under the trade name Anexate(TM). It was originally introduced in the U.S. in February 1992. It is available in more than 40 countries around the world. Roche began shipping flumazenil packaged under the new trademark Romazicon this week.
 About Hoffmann-La Roche
 Headquartered in Nutley, N.J., Hoffmann-La Roche Inc. is the U.S. affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland. One of the world's leading research-intensive health care companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals. The company is also a major provider of diagnostic products and clinical testing services, home infusion therapy services, vitamins and other products for human and animal nutrition, as well as animal drug feed additives and veterinary products. Recognized for excellence in both biotechnology and traditional chemistry, Roche is also widely known for its current efforts in the commercial development of polymerase chain reaction (PCR) technology, a revolutionary advance in diagnostics, and other fields, including biomedical research, forensics and environmental testing.
 NOTE: Mivacron(TM) is a registered trademark of Burroughs Wellcome Co.
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 /NOTE TO EDITORS: For more information about The Institute for Safe Medication Practices, Inc., or about Romazicon, call 800-284-2818/
 /CONTACT: Alfred Wasilewski of Hoffmann-La Roche, 201-235-5947, or home, 201-762-7545/

CO: Roche Laboratories ST: New Jersey IN: MTC SU:

TM -- NY005 -- 9322 08/04/93 11:17 EDT
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Publication:PR Newswire
Date:Aug 4, 1993
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