January 24, 2011

Merck Says Hepatitis B Vaccine Safe; Unrelated to TG Swab Recall

By Nazvi Careem
Published Jan 24, 2011

Healthcare company Merck said its hepatitis B and hepatitis C medicines are safe to use despite the recent recall of Triad Group alcohol prep pads by FDA.

New Jersey: The hepatitis B vaccine and hepatitis C powder produced by healthcare company Merck are safe and are not affected by the recall of potentially contaminated Triad Group alcohol swab products, according to the manufacturer.

In a press release issued on January 23, Merck moved to reassure consumers its medicines, which may be co-packaged with Triad Group products, were not affected by the recent recall initiated by the FDA and the Triad Group.

It said consumers should continue to use its Intron A and Pegintron medicines but discard the alcohol prep pads that are included in the packages.

“It is important to note that the Merck medicines are not contaminated, and should continue to be used in accordance with the package insert, and as directed by a healthcare provider, except the alcohol prep pad should be discarded,” said the press release (http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0123.html).

On January 3, the FDA and Triad Group, a manufacturer of over-the-counter products, announced the recall of alcohol prep pads, swabs and swabsticks over concerns about possible contamination with Bacillus cereus.


The recall affected products marked as “STERILE” in addition to non-sterile items with the FDA warning that their use may lead to life-threatening infections, particularly among high-risk groups such as immune-suppressed and surgical patients.

The pads and swabs are usually used as a disinfectant by wiping an area of the body before an injection.

The FDA stressed that the recall is confined to Triad Group products and not the items from other manufacturers that it might be packaged with (http://www.fda.gov/Safety/MedWatch/default.htm, last checked January 24, 2011).

The Merck products accompanying the potentially contaminated Triad Group swabs are sold in Latin America, excluding Brazil, Canada, Europe and Asia Pacific, excluding Japan.

The company said its medicines distributed in the United States are not affected by the recall of Triad Group products.

Hepatitis B vaccine

Intron A contains the man-made protein Interferon and is used in the treatment of chronic hepatitis B, in addition to hairy cell leukaemia, malignant melanoma, follicular lymphoma, AIDS-related Kaposi’s sarcoma, chronic hepatitis C and condylomata acuminata.

Pegintron is a powder that is used to make a solution used in the treatment of chronic hepatitis C in patients three years and older.

Merck said, after talks with health experts at regional government level, it would start to package orders for countries minus the alcohol prep pads until another source of the material can be identified.

It will also urge consumers in affected markets to discontinue using the pads, swabs and swabsticks because of the risk of contamination.

In addition, Merck plans education programmes in the various countries so patients can be fully informed on the products and its risks.

The information will be made available to regulatory agencies in respective countries and those conducting clinical trials using the products.


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