Warning issued to Fuzeon, Pegasys, Viraferon Peg and Intron A users

9 February 2011

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The US Food and Drug Administration has issued a warning to users of four injectable drugs that may be used by people with HIV and/or hepatitis C regarding microbial contamination of alcohol prep pads supplied with these products.

The pads, manufactured by Triad group, have been recalled following the discovery of microbial contamination of alcohol pads that are used for cleaning the injection site before injecting T-20 (Fuzeon) or one of the interferon products used in hepatitis C treatment. The pads are co-packaged with the injection pens or other devices used by patients to administer these drugs.

Genentech, the manufacturer of Fuzeon and Pegasys pegylated interferon, has recommended that patients stop using the pads supplied with their medication immediately, and throw them away.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

pegylated interferon

Pegylated interferon, also known as peginterferon, is a chemically modified form of the standard interferon, sometimes used to treat hepatitis B and C. The difference between interferon and peginterferon is the PEG, which stands for a molecule called polyethylene glycol. The PEG does nothing to fight the virus. But by attaching it to the interferon (which does fight the virus), the interferon will stay in the blood much longer.

MSD, the manufacturer of Viraferon Peg and Intron A, has issued the following advice to people currently using these injectable products in the United Kingdom:

“Alternate alcohol pads are available for purchase at your local pharmacy or you can use sterile gauze pads in conjunction with bottled isopropyl alcohol instead of the Triad Group brand alcohol pads.

You may begin receiving packages of ViraferonPeg or IntronA that do not contain alcohol prep pads. In this case, please use alternate alcohol pads that are available for purchase at your local pharmacy or you can use sterile gauze pads in conjunction with bottled isopropyl alcohol instead of the Triad Group brand alcohol pads.”

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The recall of the alcohol pads does not affect the safety or reliability of the medicines, says the US Food and Drug Administration.

Warning issued to Fuzeon, Pegasys, Viraferon Peg and Intron A users

Glossary

Food and Drug Administration (FDA)

pegylated interferon

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