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2003 Archives
VIEW ALERTS ALPHABETICALLY BY GENERIC DRUG NAME
TABLE OF CONTENTS
ANCOM ANTI-HYPERTENSIVE COMPOUND: RECALL OF DANGEROUS OTC FORMULATION (#2) Dated 1/17/2003: A recall has been issued for all bottles of Ancom Anti-Hypertensive Compound labeled to contain several prescription drug ingredients including: diazepam, reserpine, promethazine, and hydrochlorothiazide. The sale of this combination product poses serious health risks including depression, sedation, and possibly life threatening hematologic abnormalities. This product was sold OTC to consumers through distributors, retail stores, and nationwide via the Internet. Practitioners are referred to the Press Release for details about this warning. DIETARY SUPPLEMENT (Vinarol®): RECALL DUE TO CONTAMINATION WITH SILDENAFIL (#9) Dated 4/4/2003: A dietary supplement (Vinarol®) promoted for enhancing sexual performance has been recalled because it contains the prescription drug sildenafil (Viagra®). The contamination of this supplement may pose a serious health risk to some users due to the interaction between nitrates and sildenafil that can result in profound and potentially life-threatening hypotension. The concurrent use of nitrates and sildenafil is contraindicated. The potential for this product to be taken by unknowing nitrate users is a concern, since erectile dysfunction is often a concurrent condition for patients with diabetes, hyperlipidemia, hypertension, ischemic heart disease, or for smokers. Health care practitioners who treat patients with the above medical conditions should be alert for possible adverse consequences in patients known to be using this recalled dietary supplement. Practitioners are referred to the Press Release for details about this warning. ESTROGENS/PROGESTINS (Premarin®/Prempro®/Premphase®): NOT FOR PREVENTION OF CARDIOVASCULAR DISEASE (#1) Dated 1/8/2003: A boxed warning has been added to the prescribing information for Premarin®, Prempro®, and Premphase® which states that estrogen and estogen plus progestin therapies should not be prescribed for the prevention of cardiovascular disease. Practitioners are referred to FDA's drug information page and to the Dear Doctor Letter for details about this warning and are urged to review the revised prescribing information - Prempro®/Premphase®; Premarin® online. INTERFERON BETA-1A (Avonex®): CAUTION IN PATIENTS WITH PSYCHIATRIC DISORDERS (#7) Dated 3/7/2003: Prescribers are notified that sections of the prescribing information for interferon beta-1a (Avonex®), used to treat patients with multiple sclerosis, have been updated. There have been reports of depression, suicidal ideation and/or development of new or worsening of pre-existing psychiatric disorders (including psychosis) occurring in patients treated with this drug. Prescribers are urged to use caution when prescribing interferon beta 1-a both for patients with pre-existing psychiatric disorders and for those at risk of developing psychiatric symptoms. Practitioners are referred to the Dear Doctor Letter for details about this warning and are urged to review the revised prescribing information online. LINDANE lotion/shampoo: REMINDER FOR APPROPRIATE USE (#8) Dated 3/28/2003: The prescribing information for lindane topical formulations (lotion and shampoo), used for the treatment of scabies and lice, has been revised and reflects updated information on appropriate use. This information emphasizes that lindane topicals are considered second-line treatments. Other information includes updates regarding potential risks (primarily in children and adults weighing less than 100 pounds), and a reminder that reapplication of lindane is not appropriate treatment if itching continues after the recommended single treatment. Practitioners who routinely prescribe these products are referred to the FDA Public Health Advisory for details about this warning and are urged to review the revised package insert - shampoo; lotion online. NEFAZODONE/QUETIAPINE (Serzone/Seroquel®): POTENTIAL MEDICATION ERROR (#4) Dated 2/13/2003: Prescribers are cautioned about the potential for medication errors involving the antidepressant nefazodone (Serzone®) and the antipsychotic quetiapine (Seroquel®). Name confusion between Serzone® and Seroquel®, the overlapping drug strengths (100mg and 200mg), the same dosage form (tablets), the dosing interval (BID), and the fact that these two products are commonly stocked close together on pharmacy shelves are all factors that increase the likelihood that a serious medication error could occur. Prescribers can help minimize the chance that a pharmacy medication error will occur by writing both the brand and generic name on the prescription and also by including the indication for the the medication's use. Practitioners are referred to the Dear Doctor Letter for details about this warning. PERGOLIDE (Permax®): CARDIAC VALVULOPATHY (#6) Dated 2/24/2003: FDA has received reports of cardiac valvulopathy in patients receiving pergolide (Permax®), indicated for the treatment of Parkinson's disease. The aortic, mitral, and tricuspid valves were involved in reported cases. In some instances, the symptoms of valvulopathy improved when pergolide therapy was halted. However, valve replacement was required in two patients. Health care practitioners should be alert to the possibility of valve dysfunction in their patients taking pergolide. Practitioners are referred to the Dear Doctor Letter for details about this warning. RISPERIDONE (Risperdal®): CEREBROVASCULAR ADVERSE EFFECTS REPORTED (#10) Dated 4/16/2003: The Warnings section of the package insert for the anti-psychotic drug risperidone (Risperdal®) has been revised to reflect new information regarding reports of sometimes fatal cerebrovascular events in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a higher incidence of cerebrovascular events (stroke, transient ischemic attack) in patients treated with risperidone compared to patients treated with placebo. Practitioners should be aware of the increased potential for adverse cerebrovascular events in geriatric patients taking resperidone and monitor their elderly patients closely. Practitioners are referred to the Dear Doctor Letter for details about this warning and are urged to review the revised prescribing information online. SALMETEROL (Serevent®): SERIOUS ADVERSE RESPIRATORY EFFECTS (#3) Dated 1/24/2003: FDA notifies prescribers that an interim analysis of a large safety study of the inhaled asthma drug salmeterol (Serevent®) shows that the drug may be associated with an increased risk of asthma-related deaths and life-threatening asthma episodes. Further analysis of the study data suggests that the risks may be greater for African-American patients and for patients not taking inhaled corticosteroids. Practitioners are referred to the FDA Talk Paper and to the Dear Doctor Letter for details about this warning. SIROLIMUS (Rapamune®): FATAL BRONCHIAL ANASTOMOTIC DEHISCENCE (#5) Dated 2/20/2003: Practitioners prescribing sirolimus (Rapamune®) are alerted to reports of potentially fatal bronchial anastomotic dehiscence in lung transplant patients receiving this immunosuppressant drug in combination with tacrolimus and corticosteroids. In one report, 4 of 15 patients enrolled in a study developed the disorder and 3 of those died. In a second report, 2 cases of bronchial anastomotic dehiscence were reported, one of which was fatal. Further information regarding these reported cases will be published in a future issue of the journal Transplant. Practitioners should be vigilant for adverse respiratory symptoms in their transplant patients taking this medication. Practitioners are referred to the Dear Doctor Letter for details about this warning.
About Safety-Related Drug Alerts! In response to practitioner demand, the Drug Information Center has joined together with the Medical Director's office to assist in the timely dissemination of safety-related drug alerts. Once every two weeks, brief summaries of the drug alerts judged to be most relevant to the care of UWMC and HMC patients are forwarded via email to the UWMC, HMC, and UWPN Medical Directors for further dissemination to clinical practitioners. "Safety-Related Drug Alerts!" encompass formulary and non-formulary prescription and non-prescription drugs, products regulated as food supplements, and medical devices that may be prescribed by UWMC/HMC/UWPN practitioners or used by UWMC/HMC/UWPN patients. "Safety-Related Drug Alerts!" may originate from the FDA, pharmaceutical manufacturers, or other sources deemed reliable. Your assistance in helping to achieve dissemination of this information to all levels of UWMC, HMC, and UWPN health care providers, including physicians, nurse practitioners, physician's assistants, and other allied health professionals, is appreciated. Copies of the full-text original sources for Safety-Related Drug Alerts! are available on request from the Drug Information Center (druginfo@u.washington.edu; 598-6347) and electronically via the World Wide Web at the URL listed at the end of each alert. In addition, Safety-Related Drug Alerts! are archived on the UWMC Department of Pharmacy's PRN website. Questions about Safety-related Drug Alerts should be addressed to the Drug Information Center (548-6347; druginfo@u.washington.edu).
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