Seroquel aimed at reducing possible dispensing confusion with Serzone

AstraZeneca announced that it is changing the appearance of container labeling and packaging for Seroquel (quetiapine fumarate), which is indicated for the treatment of schizophrenia in adults. It's part of an effort to reduce the potential for medication dispensing errors with Serzone (nefazodone hydrochloride), an antidepressant manufactured by Bristol-Myers Squibb Company. AstraZeneca said it is continuing to work closely with the FDA to design an educational program to address the issue. The multi-faceted educational campaign about the new labeling and packaging, as well as how to prevent future medication errors was launched on May 20, when AstraZeneca also sent out a "Dear Healthcare Professional" letter informing physicians and pharmacists of the potential for medication dispensing errors with Serzone. [You can find the letter at www.fda.gov/medwatch] Instances of prescribing errors have involved either Serzone being substituted for Seroquel, or vice-versa. Medication dispensing errors are often a result of miscommunication, such as poor handwriting on prescription forms, and confusion between drugs with similar names. Astrazeneca said that it is important to note that the FDA concerns do not pertain to the safety, efficacy or tolerability of Seroquel, a first-line atypical antipsychotic, when properly prescribed and dispensed. Seroquel is one of many prescription drugs that have recently received attention with regard to medication dispensing errors. "AstraZeneca is cooperating fully with the FDA to ensure a number of actions are taken to address future medication errors involving Seroquel and Serzone," said James Pusey, MD, vice president, CNS, Pain and Infection therapy area. "Schizophrenia is a serious disease and an interruption in treatment can lead to negative consequences for the patients. AstraZeneca is a responsible company and our most important priority is to ensure that our products are being administered appropriately and safely." In order to more clearly differentiate Seroquel from Serzone on pharmacy shelves, AstraZeneca is creating new package labels emphasizing the "QUEL" in a new font and color, and is changing the bottle cap from white to blue. This should be available shortly. The company will also be communicating with the National Mental Health Association (NMHA) and the National Alliance for the Mentally Ill (NAMI), to make them aware of the issue. The educational awareness campaign will also include: Ads in professional journals describing the issue of medication errors and providing a visual of the revised packaging Patient information wallet card Shelf tags Self-inking Seroquel prescription stamps for distribution to physicians. Professionals and patients can also visit www.seroquel.com for more information, or they can contact AstraZeneca at 800-236-9933. The labeling for Seroquel (quetiapine fumarate) Tablets includes a warning relative to a condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents), and a rare condition known as neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Labeled precautions include orthostatic hypotension and the possible risk of cataract development. As with other antipsychotics, therapy with Seroquel should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold.