FDA Rejects Thimerosal Petition

FDA has rejected a petition that sought new restrictions on the use of the preservative thimerosal in vaccines and medications, the agency said in a reply dated Sept. 26 that was made public on Tuesday, the AP/Seattle Post-Intelligencer reports. The Coalition for Mercury-free Drugs filed the petition in 2004 over its concerns that thimerosal is linked to autism.

The coalition and some other groups maintain that thimerosal, which is about 50% mercury by weight, causes the condition. All vaccines given to children ages six and younger since 2001 have been thimerosal-free or contained only trace amounts of the preservative.

Some adult vaccines, eye ointments, nasal sprays and nasal solutions still contain thimerosal.

Jeffrey Shuren, assistant commissioner for policy at FDA, wrote in the denial of the petition, "Only a small number of licensed and approved products still contain thimerosal, and the available evidence supports FDA's conclusion that all currently licensed vaccines and other pharmaceutical drug products containing thimerosal are safe."

Mark Geier, one of the petitioners, said, "We're not accepting that as an answer," adding that the group would seek a court order that would force FDA to remove thimerosal from all vaccines and medications.

Seasonal flu vaccines contain thimerosal, although some manufacturers offer thimerosal-free versions of the shot for children. FDA said it is in discussions with those manufacturers to increase the supply of thimerosal-free flu vaccine (Bridges, AP/Seattle Post-Intelligencer, 10/24).

A state law took effect on Saturday, effectively banning vaccines containing the preservative thimerosal from use in pregnant women and children younger than age three (California Healthline, 7/6).