RISPERDAL CONSTA (risperidone powder for injectable prolonged-release suspension) - Needle Detachments Associated with the Needle Assembly Used for Gluteal Injection - For Health Professionals

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
 
This is duplicated text of a letter from Janssen-Ortho Inc.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on the Needle Assembly of RISPERDAL CONSTA (risperidone powder for injectable prolonged-release suspension)

April 7, 2010

Dear Health Care Professional,

Subject: Needle detachments associated with the needle assembly used for the gluteal injection of RISPERDAL^® CONSTA^® risperidone powder for Injectable Prolonged-Release Suspension

Janssen-Ortho, in cooperation with Health Canada, would like to provide you with important information concerning the needle assembly used for the gluteal injection for RISPERDAL^® CONSTA^® (risperidone).

Importantly, please note that the drug itself, the risperidone microspheres powder, along with the supplied diluent for reconstitution, are not affected by the needle assembly and detachment.

There has been a recent increase in the number of reports of difficulty in attaching the orange NEEDLE-PRO^® safety device with the 2-inch gluteal injection needle onto the luer connection of the syringe included in the RISPERDAL^® CONSTA^® kit. In some cases, the orange NEEDLE-PRO^® safety device "turns back" after attachment to the syringe luer-lock (white collar).

Janssen-Ortho has received 83 complaints related to needle detachment over the past 3 months. This represents 1 complaint per 660 units sold. Of the 83, 5 reported missed or partial administration of a dose, which represents 1 case per 11,500 units sold. The analysis of the root cause of this issue is in progress. Manufacturing improvements have been identified and are progressing towards implementation as soon as possible.

Recommendations:

RISPERDAL^® CONSTA^® requires close attention to the step-by-step instructions for use to ensure successful administration. After following the Instructions for Use provided with product, Janssen-Ortho recommends that prior to injection, the health care professional recheck the connection between the orange NEEDLE-PRO^® safety device and the syringe to confirm that a secure attachment has been made. Clinicians are advised to manage individual situations of missed or partial doses on a case-by-case basis.

Please report any occurrence of needle detachment immediately to Janssen-Ortho. In cases where needle detachment makes it unfeasible to administer the medication, Janssen-Ortho will replace the kit free of charge.

RISPERDAL^® CONSTA^® (risperidone) is indicated for the management of the manifestations of schizophrenia and related psychotic disorders. RISPERDAL^® CONSTA^® is also indicated as a monotherapy maintenance treatment in patients with bipolar I disorder, who have previously responded to oral antipsychotics or other anti-manic treatment, to delay occurrence of manic episodes.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any case of needle detachment, needle stick injury, incomplete injection of RISPERDAL^® CONSTA^®, or other adverse event, should be reported to Janssen-Ortho, or Health Canada (for serious/unexpected events), at the following addresses:

original signed by

Dr. Cathy Lau,
Vice President, Regulatory Affairs and Quality Management