Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs.

Spontaneous adverse event reports constitute an important source of information on previously unknown adverse reactions to marketed medicines. However, the dynamics of such reporting following generic introduction are poorly understood. Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of product-identifying information contained therein. The majority of reports were sent by innovator drug manufacturers while few were sent by generic manufacturers, even when generics accounted for >90% of dispensed prescriptions. We manually reviewed narratives from 2,500 reports and found that the suspect product type (brand or generic) could not be determined in 84% of reports, while generic products (16%) were identified more often than brand-name products (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices.

Clinically significant liver injury in patients treated with natalizumab.

BACKGROUND: Natalizumab is a recombinant monoclonal antibody approved for the treatment of patients with multiple sclerosis and patients with Crohn's disease. Because of its immunosuppressive effects, natalizumab has been associated with a number of atypical and opportunistic infections. AIM: To describe and summarize six spontaneously reported post-marketing cases of clinically significant drug induced-liver injury associated with natalizumab use. METHODS: The FDA maintains a database of adverse event reports (AERS). We searched the AERS database for reports of serious liver injury associated with natalizumab use from November 2004, when the drug was approved, through 30 June 2008. RESULTS: The search resulted in six spontaneously reported post-marketing cases of severe drug-induced liver injury. Four of six patients developed liver injury with elevations of serum transaminases and hyperbilirubinemia after only a single infusion of natalizumab. One of these patients experienced repeated increases of aminotransferases and bilirubin when natalizumab was re-administered. CONCLUSIONS: Serious hepatic injury may occur in association with natalizumab use. Health professionals should be alerted to possible serious liver injury in patients receiving natalizumab.

Possible short-term memory loss associated with nafarelin acetate.

OBJECTIVE AND DESIGN: A survey was conducted to determine the occurrence of short-term memory loss in patients using nafarelin acetate nasal spray. SETTING AND PATIENTS: A list of all patients receiving nafarelin acetate from our pharmacy over a four-month period was generated. We contacted and surveyed 16 women. INTERVENTIONS: Each patient was asked to repeat three words at the beginning of the survey and after a series of questions, each patient was asked to recall the three words. Patients were also asked if they believed that their memory was affected by nafarelin acetate nasal spray. RESULTS: Eleven patients (69 percent) recalled three words, 3 (19 percent) recalled two words, and 2 (13 percent) recalled one word at the conclusion of the survey. Nine of 16 patients (56 percent) reported some type of memory difficulty. CONCLUSIONS: Nafarelin acetate nasal spray may adversely affect short-term memory. This effect is not documented in current literature and further investigation is warranted in the possible relationship between gonadotropin releasing hormone agonists, estrogen deficiency, menopause, and short-term memory. Our survey also demonstrates the significance of communication between pharmacists and patients on newly marketed medications.