(ATDN) IVIG Recalled by Pharmaceutical

(ATDN) IVIG Recalled by Pharmaceutical

Treatment Review No. 11; April 1994

Immunoglobulins (IgG) are parts of the immune system called antibodies. Antibodies attach to viruses and bacteria in the blood and tissue, alerting the body to get rid of them. IVIG is a drug given by infusion and sometimes by injection. IVIG stands for intravenous immunoglobulin. IVIG creates a passive immune response. This means the drug IVIG replaces or substitutes for what the immune system doesn't or can't do by itself. The drug IVIG contains many different types of antibodies.

IVIG is used to treat children with AIDS. It is being studied in clinical trials to see whether it can help prevent the unborn babies of HIV+ mothers from becoming infected with HIV. IVIG is also approved for the treatment of bleeding disorders in people with hemophilia, and for the treatment of idiopathic thrombocytopenia, or ITP (low platelet counts that can be associated with HIV). Side effects of IVIG rarely occur, although there may be pain at the infusion site, headache, and malaise.

IVIG products are made by five different pharmaceutical companies. An organization named COTT (Committee of Ten Thousand, an organization for hemophiliacs) alerted The Network that two brands of the drug IVIG have been taken off the market. They have been recalled because of evidence that up to twenty people have developed hepatitis C after taking the drug. The two brands of IVIG that were recalled are Gammagard (made by Baxter/Hyland), and Polygam (made by the American Red Cross).

A new formulation of IVIG has been developed by Baxter. The way this new drug is made involves killing possible contaminants such as hepatitis C by washing the drug with a type of detergent. This process is also used in other brands of IVIG.

COTT recommends that if you have any Gammagard at home, you should contact your doctor or clinic to find out how to properly dispose of it. Do not use any leftover Gammagard. Gammagard will be collected from doctors and clinics by Baxter. If you have any other information or have questions about IVIG, please call The Network, or COTT at 1-800-488-COTT.

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Always watch for outdated information. This article first appeard in 1994. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1994. AEGIS.