Titre du document / Document title

FDA halts distribution of paxil CR : Understanding the implications and options

Auteur(s) / Author(s)

BERGER Matthew ; GINSBERG David L. ; KURLANDER Ronald ; SUSSMAN Norman ;

Résumé / Abstract

On March 4, 2005, the United States Food and Drug Administration took the rare course of action to have US Marshals seize lots of two GlaxoSmithKline products manufactured at their Puerto Rico production facility due to manu&cturing problems. One of those products was the selective serotonin reuptake inhibitor (SSRI) antidepressant Paxil controlled release (CR). The manufacturer has recently reported that they expect to begin re-supplying the product in mid-summer, but the current product shortage has created an immediate need for clinicians to evaluate and select alternative treatment options for patients who were being treated with Paxil CR. It is important for physicians to consider alternatives for their patients, particularly if the re-supply of Paxil CR encounters any delays. In selecting alternative treatments it is important to understand that the FDA actions were not related to the active paroxetine moiety, but to manufacturing problems causing the Paxil CR Geomatrix tablets to split apart. The potential risk is that the patient may receive the portion containing active drug without the intended controlled-release effect, or only the portion containing inactive ingredients. Given the recent high-profile FDA recalls and prescription drugs withdrawn from the US market, additional communication with patients may be necessary to minimize unwarranted fears or even sudden discontinuation of treatment. The alternatives to Paxil CR consist of all other antidepressants, in addition to other forms of paroxetine. For patients whose symptoms are currently controlled on paroxetine, or those for whom paroxetine would be the desired choice, other forms of paroxetine are available. The paroxetine options consist of immediate-release Paxil, generic immediate-release paroxetine, and Pexeva. Pexeva is a different salt of paroxetine (mesylate compared to Paxil CR hydrochloride) and is the most recent paroxetine entry. Pexeva appears to be the only branded paroxetine promoted at this time and samples are available from the manufacturer (Synthon Pharmaceuticals). This roundtable monograph explores the implications of the current Paxil CR shortage from the perspectives of three practicing psychiatrists.

Revue / Journal Title

Primary psychiatry   ISSN 1082-6319 

Source / Source

2005, vol. 12, n^o6, pp. 1-8 [8 page(s) (article)]

Langue / Language

Anglais

Editeur / Publisher

MBL Communications, New York, NY, ETATS-UNIS  (1994) (Revue)

Localisation / Location

INIST-CNRS, Cote INIST : 27609, 35400013818233.0050