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From Cephalon February 14, 2005 Cephalon, Inc., would like to inform you of important, new safety information for GABITRIL (tiagabine HCL) tablets regarding the risk of new onset seizures and status epilepticus in patients without a history of epilepsy. From the launch of GABITRIL in 1997 through December 31, 2004, there have been 59 postmarketing reports of seizures in patients without a history of epilepsy. Clinicians are advised to carefully review the information shown below, which had been added to the GABITRIL prescribing information. WARNINGS Seizures in Patients Without Epilepsy: Post-marketing reports have shown that GABITRIL use has been associated with new onset seizures and status epilepticus in patients without epilepsy. Dose may be an important predisposing factor in the development of seizures, although seizures have been reported in patients taking daily doses of GABITRIL as low as 4mg/day. In most cases, patients were using concomitant medications (antidepressants, antipsychotics, stimulants, narcotics) that are thought to lower the seizure threshold. Some seizures occurred near the time of a dose increase, even after periods of prior sable dosing. The GABITRIL dosing recommendations in current labeling for treatment of epilepsy were based on use in patients with partial seizures 12 years of age and older, most of whom were taking enzyme-inducing antiepileptic drugs (AEDs; e.g., carbamazepine, phenytoin, primidone, and phenobarbital) which lower plasma levels of GABITRIL by inducing its metabolism. Use of GABITRIL without enzyme-inducing antiepileptic drugs result in blood levels about twice those attained in the studies on which current dosing recommendations are based (see DOSAGE AND ADMINISTRATION). Safety and effectiveness of GABITRIL have not been established for any indication other than as adjunctive therapy for partial seizures in adults and children 12 years and older. In nonepileptic patients who develop seizures while on GABITRIL treatment, GABITRIL should be discontinued and patients should be evaluated for an underlying seizure disorder. Seizures and status epilepticus are known to occur with GABITRIL overdosage (see OVERDOSAGE). Other changes to the label can be found in the PHARMACOKINETICS, ADVERSE REACTIONS, OVERDOSAGE, and DOSAGE AND ADMINISTRATION sections of the label. GABITRIL is approved for use only as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Because GABITRIL has not been systematically evaluated in adequate and well-controlled clinical trials for any other indication, its safety and effectiveness have not been established for any other use. Cephalon does not recommend the use of GABITRIL outside of its approved indication. Dosing guidelines for GABITRIL have been established only for its use as an adjunctive treatment for partial seizures and not for any other indication. The current dosing guidelines for GABITRIL have been established primarily for patients 12 years and older with partial epilepsy who are taking hepatic enzyme-inducing anticonvulsant drugs. Patients who are not taking enzyme-inducing drugs would have systemic exposure to tiagabine that is higher than expected. Thus, these patients require lower doses of GABITRIL and may require a slower titration rate. Clinicians should exercise caution when prescribing GABITRIL in uninduced patients. Cephalon is committed to providing you with important information for the safe and effective use of GABITRIL. Cephalon will continue its pharmacovigilance efforts and will work closely with health authorities including the U.S. Food and Drug Administration (FDA) to ensure that appropriate safety information is included in GABITRIL prescribing information. Enclosed please find the updated prescribing information for GABITRIL. Should you have nay questions regarding this important safety information, please contact Cephalon Professional Services at 1-800-896-5855. As always, we request that serious adverse events be reported to Cephalon at 1-800-896-5855 or the the FDA's MedWatch Adverse Event Reporting program online at www,fda.gov/MedWatch/report.htm, by phone at 1-800-FDA-1088, or by returning the postage-paid FDA form 3500, which may be downloaded form www.fda.gov/MedWatch/getforms.htm. Sincerely, Elizabeth M. Mutisya, MD Vice President Medical Affairs
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Update for Pharmacists and wholesalers regarding supply disruption of Paxil CR and Avandamet March 18, 2005 This is to alert you that Paxil CR (paroxetine hydrochloride) and Avandamet (rosiglitazone maleate/metformin hydrochloride) Tablets are in extremely short supply. Shortages have resulted form the March 4, 2005, seizure action (due to manufacturing issues) by the U.S. Food and Drug Administration, currently disrupting the supply of these two products. The FDA action relates to all strengths of Paxil CR (12.5mg, 25 mg, and 37.5 mg) as well as Avandamet (1mg/500 mg, 2 mg/500 mg, 2 mg/1000 mg, 4 mg/500 mg and 4 mg/1000 mg). GlaxoSmithKline believes that the manufacturing issues do not present a health risk to patients. GSK agrees with the FDA that patients who use these two medicines should continue taking their tablets while supplies last. Prescribers have been advised to consider other treatment options for new patients and for patients unable to fill current prescriptions for these medications. If you are unable to fill prescriptions for these two medications, please advise patients to contact their healthcare professional about other treatment options. Because Paxil CR and the immediate-release formulation of Paxil are not bioequivalent, we cannot make any definitive recommendations about this treatment option. In terms of Avandamet, physicians may choose to transfer patients to comparable dosages and dosing regimens of Avandia ( rosiglitazone maleate) and metformin as separable tablets to ensure the equivalent daily dose is given. Please be assured that GSK is working with the FDA to resolve these issues as quickly as possible, and we will continue to keep you informed of our progress. We regret any inconvenience this action may cause. Should you have further questions, please contact the GSK Customer Response Center at 1-888-825-5249 between the hours of 8 am and 8 pm EST, Monday through Friday. Sincerely, John L. Fish Vice President Trade, Pharmacy Sales and Operations. Please see accompanying complete Prescribing Information for Paxil and Paxil CR, including BOXED WARNING. Please see accompanying complete Prescribing Information for Avandamet and Avandia, including Avandamet BOXED WARNING for lactic acidosis and contraindications for patients with renal disease and congestive heart failure.
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Fayetteville, Arizona Washington Medical Center offers a competitive salary and benefit package. This includes relocation assistance. Washington Regional is a 295 bed intense care medical center. It offers a high quality of life action. Currently experiencing growth and are moving into new medical center in August 2002. For more information please call 501-713-1066, fax 501-713-1296, or go online at www.wregional.com
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Pharmacist Payson, Arizona - Payson Regional Medical Center, is seeking a full time pharmacist with good communication skills and an active team spirit. You will work weekdays with rotating weekends, and some days on call. We offer benefits and a competitive salary. Must have a BS in science with previous hospital experience. For more information call 520-472-1268, fax 520-472-1293, or go online at www.paysonhospital.com
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