You have reached the HIVandHepatitis.com legacy site. Please visit our new site at hivandhepatitis.com

Genentech Warns of Infection Risk from Alcohol Pads Packaged with Fuzeon and Pegasys

SUMMARY: Genentech last week notified patients that alcohol pads packaged with certain injectable drugs -- including the HIV entry inhibitor enfuvirtide (Fuzeon; T-20) and pegylated interferon alfa-2a (Pegasys) used to treat hepatitis B and C -- may be contaminated with bacteria that could cause serious infection, especially in people with suppressed immune function. Triad Group, which manufactures the potentially contaminated alcohol pads and swabs, has announced a market recall. Genentech emphasized that only the alcohol products, not the medications themselves, are affected.

Below is the text of a recent Genentech advisory outlining the concerns.

Genentech Informs Customers of Important Information
about Triad Group's Alcohol Prep Pads

Consumers Alerted to Discontinue Use of Alcohol Prep Pads Packaged with Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, TNKase Medicines

South San Francisco, Calif. -- January 13, 2011 -- Genentech, Inc., a member of the Roche Group, has become aware of the market recall of Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKaseto customers in the United States.

According to the Food and Drug Administration's (FDA) Medwatch communication, the recall was initiated due to concerns about potential contamination of the Triad Group's products with the bacteria, Bacillus cereus. This recall involves those products marked as sterile as well as non-sterile. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

It is important to note, that Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall, or alternatively use a sterile gauze pad in conjunction with isopropyl alcohol for disinfecting the injection site prior to administration.

Genentech is in discussion with the FDA and is currently assessing alternatives to address the situation. The company plans to issue a Dear Healthcare Provider letter to potential prescribers and pharmacists to make them aware of the Triad product recall and the need to discontinue use of the alcohol prep pads packaged with Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase.

Patients should consult their healthcare provider for further information. Healthcare providers with questions may contact the Patient Resource Center at 1-877-436-3683 between the hours of 6 a.m. and 5 p.m. Pacific Time.

For the Boniva indication, full prescribing information, and important safety information, please visit www.boniva.com.
For the Fuzeon indication, full prescribing information, and important safety information, please visit www.fuzeon.com.
For the Nutropin A.Q. Pen indication, full prescribing information, and important safety information, please visit www.nutropin.com.
For the Pegasys indication, full prescribing information, and important safety information including Boxed Warning and Medication Guide, please visit www.pegasys.com.
For the TNKase indication, full prescribing information, and important safety information, please visit www.tnkase.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

1/18/11

Sources

Genentech. Genentech Informs Customers of Important Information about Triad Group's Alcohol Prep Pads. Media advisory. January 13, 2010.

FDA. Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination. Press release. January 5, 2011.



 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 Google Custom Search
FDA-approved HIV
and AIDS Treatments
Protease Inhibitors PIs
non Nucleoside Reverse
  
Transcriptase Inhibitors nNRTIs
Nucleoside / Nucleotide
  
Reverse Transcriptase Inhibitors NRTIs
Fixed-dose Combinations
Entry / Fusion Inhibitors EIs
Integrase Inhibitors

Experimental Treatments

CURRENT CME PROGRAMS

Noimage

Noimage
HIV Road Trip: Current Management Pathways and the Road Ahead

Noimage

Noimage

Noimage