Suicidal risk warnings to be added to antiepileptics

January 2009
Reactions Weekly;1/10/2009, Issue 1234, p2
The article reports on the announcement of the U. S. Food and Drug Administration (FDA) that it will require manufacturers of antiepileptic drugs to add a warning to the products' prescribing information or labelling that their use increases the risk of suicidal thoughts and behaviours. The requirements to be submitted by manufacturers include a Risk Evaluation and Mitigation Strategy.


Related Articles

  • Efalizumab: updated labelling.  // WHO Drug Information;2008, Vol. 22 Issue 4, p292 

    The article offers updates on the policy of the U.S. Food and Drug Administration (FDA) regarding the use of efalizumab. It states that the FDA has announced labelling changes of efalizumab, commercially known as Raptiva, and has required the submission of a Risk Evaluation and Mitigation...

  • Labeling Of Anticonvulsant May Be Changed. Vernarec, Emil // RN;Aug2000, Vol. 63 Issue 8, p101 

    Reports that the United States Food and Drug Administration may require the manufacturer of anticonvulsants fosphenytoin and phenytoin to change their labeling. Response to post-marketing reports of cardiovascular adverse events; Report awaited from manufacturers before considering revisions.

  • Safer drugs for children.  // Journal of the American Dental Association (JADA);Jan1999, Vol. 130 Issue 1, p33 

    Reports on the United States Food and Drug Administration's final regulations to provide health care practitioners with specific information on the safe and appropriate use of new drugs and biological agents in children. Labeling of new drugs and biological agents; Pediatric testing of...

  • Draft Guidance Document for Industry. Heisey, Colleen; Spector-Bagdady, Kayte // Contract Pharma;Oct2010, Vol. 12 Issue 8, p22 

    The article focuses on the draft guidance document on chemistry, manufacturing, and controls (CMC) review released by the U.S. Food and Drug Administration (FDA) on June 24, 2010. It states that new drug applicants, after submitting a new drug application (NDA) or an abbreviated new drug...

  • NicOx: FDA approval a step closer for naproxcinod, but marketing partner remains elusive.  // PharmaWatch: Monthly Review;Nov2009, Vol. 8 Issue 11, p24 

    In this article the author discusses the move of NicOx SA in filing a New Drug Application for osteoarthritis treatment naproxcinod to the U.S. Food and Drug Administration (FDA). The author notes that the success of the drug will hinge the company in obtaining a marketing partner. This could...

  • WASHINGTON INSIDER: Update.  // Medical Marketing & Media;Oct2007, Vol. 42 Issue 10, p15 

    The article offers U.S. news briefs related to the pharmaceutical industry. The U.S. Food and Drug Administration (FDA) has ordered Pfizer Inc. to submit a plan for a discontinuance on the use of its drug Geodon following a misleading advertisement. The FDA has ordered Novartis AG to submit a...

  • SUICIDE. TATUM IV, WILLIAM O.; KAPLAN, PETER W.; JALLON, PIERRE // Epilepsy A to Z: A Concise Encyclopedia;2009, p327 

    An encyclopedia entry for "suicide" is presented. It is noted that people with epilepsy (PWE) are ten times more likely to commit suicide than the general population. Risk factors associated with suicide include an axis 1 diagnosis, physical health problems, family issues and life stressors. The...

  • An Update on Antiepileptic Drugs and Suicide: Are There Definitive Answers Yet? Hesdorffer, Dale C.; Berg, Anne T.; Kanner, Andres M. // Epilepsy Currents;Nov/Dec2010, Vol. 10 Issue 6, p137 

    In 2008, the Food and Drug Administration (FDA) issued a warning that any and all antiepileptic drugs (AEDs) might increase the risk of suicidal ideation, suicide attempt, and completed suicide. Considerable confusion and concern followed regarding the use of these drugs, in general, and...

  • Look for a boxed warning against intrathecal use on contrast agents. Rodman, Morton J.; Hurley, Mary Lou // RN;Dec93, Vol. 56 Issue 12, p79 

    Reports on the request by the Food and Drug Administration (FDA) for contrast agents to carry a boxed warning on carton, vial and package inserts that reads `Not For Intrathecal Use'. `FDC Reports' as source; Severe reactions of patients.


Other Topics