China Investigating Reports Of HIV-Tainted Medication (IVIG)
Chinese authorities say they are investigating a batch of medication that is suspected to be tainted with HIV.
According to local media, the batch contains more than 12,000 doses of human immunoglobulin — intravenous treatments used to boost weakened immune systems.
China's National Health Commission said in a statement that on Tuesday it asked medical institutions to stop using the suspect medicine, seal it and monitor any patients who might be impacted. It launched a recall of the product, which it says was produced by Shanghai Xinxing Pharmaceutical Company.
- By Merrit Kennedy, NPR.org
Statement from PPTA - Plasma Protein Therapeutics Association
Safety & Immunoglobulin Manufacturing
Recent news reports called into question the safety of immunoglobulin therapies outside
of Europe and the U.S. While the facts in this case are not clear, PPTA can provide
assurance that plasma protein therapies manufactured by PPTA member companies are
safe. All undergo viral removal and inactivation steps during production. These steps are
effective in helping to eliminate risks from HIV, hepatitis, and other blood-borne infectious
agents, and the safety record of current therapies is excellent; there have been no viral
transmissions for nearly three decades.
PPTA member companies adhere to or exceed all requirements set out by regulatory
authorities around the world, including the U.S. Food and Drug Administration (FDA), the
European Medicines Agency (EMA), and others. Additionally, PPTA member companies
comply with a robust set of voluntary industry standards, including the International
Quality Plasma Program (IQPP) and the Quality Standards of Excellence, Assurance and
Leadership (QSEAL). Learn more about PPTA's Pathogen Safety program here.