From: Purdue
05/04/04
URGENT RECALL INFORMATION Retail
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PURDUE |
Product: OxyContin (oxycodone HCL, controlled-release) Tablets
Manufactured by: Purdue Pharmaceuticals L.P. Wilson, NC 27893 |
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REASON |
Purdue is recalling Lot WS301, 20 mg OxyContin Tablets, 100-count bottle, because a pharmacist identified one (OxyContin 10 mg) tablet after opening a sealed 100-count bottle of OxyContin 20 mg Tablets, Lot WS031. Purdue is conducting a Class III recall, to the retail level. Health hazard: A Class III recall is for situations in which use of, or exposure to, the product is not likely to cause adverse health consequences. |
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ACTION |
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OTHER INFORMATION |
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03-16-2005 From: Warner Chilcott Femring and Estring: 2 Different Products On occasion Warner Chilcott's Medical Affairs Department receives calls from medical offices, patients and pharmacists asking for additional information or clarification about Femring, a Warner Chilcott product. Over the past 5 months we have received calls asking whether Estring and Femring are interchangeable products. As you probably know, Estring is a vaginal ring (marketed by Pfizer, Inc.) delivering estradiol 0.0075 mg per day and is indicated for the treatment of urogenital symptoms associated with post-menopausal atrophy of the vagina and lower urinary tract. Femring is also a vaginal ring, but delivers estradiol 0.05 and 0.10 mg per day and is the only vaginal treatment indicated for both vasomotor and vaginal symptoms. Femring therapy is indicated in the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause. Treating vasomotor symptoms requires systemic levels of estrogen, which Femring does deliver. Other vaginal products should be considered if treating only the symptoms of vulvar and vaginal atrophy. The Precaution section of the prescribing information recommends that a progestin be considered in women with a uterus who use Femring. Femring and Estring are not interchangeable products. The full prescribing information for Femring is enclosed. Please see the attached full prescribing information for important safety considerations regarding estrogen use in menopausal women. Estrogens have been associated with an increased risk of endometrial cancer, myocardial infarction, stroke, invasive breast cancer, pulmonary embolism and deep vein thrombosis. Estrogens should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual women. Estrogens should not be used for the prevention of cardiovascular disease. Further information can be found on the Femring web page: www.femring.com or by calling Medical Affairs at 1-800-521-8813. I hope that this information will be helpful to you in your patients care. Best Regards, Kelly Smith, MD MHS Director Medical Affairs |
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February 2005
From Pfizer
Effective January 13, 2005, the Arthrotec (diclofenac sodium/misoprostol) Voucher Program has been discontinued; therefore, vouchers will no longer be honored.
This program is currently being re-evaluated. Note that there were no product or quality-control issues with this program.
Arthrotec is available only as a unit-of-use package that includes a leaflet containing patient information. The patient should read the leaflet before taking Arthrotec and each time the prescription is renewed because the leaflet may have been revised. Arthrotec 50 is available in 60- and 90- count bottles; Arthrotec 75 is available in 60-count bottles.
Thank you for your participation in this program. We apologize for any inconvenience caused by putting you in the middle of this situation. Your continued support of the Arthrotec brand is greatly appreciated.
If you have any questions, please call us at 1-877-465-6437.
Sincerely,
US Diversified Products Team
Pfizer Inc
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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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