FDA Approves Antivenom Produced In Mexico

By Jose Luis Jiménez, Mónica Ortiz Uribe
August 03, 2011

Part 1: Mexican Drug May Solve U.S. Antivenom Shortage

The first multimedia story in a series looking at the lack of antivenom to treat scorpion bites throughout the Southwest.

Part 2: Horses Key To Making Antivenom Up For FDA Approval

The last multimedia story in a series looking at the lack of antivenom to treat scorpion bites throughout the Southwest.

The Food and Drug Administration (FDA) approved a new antivenom to treat scorpion stings, which is believed to be the first drug developed in Latin America to be approved for sale in the United States.

The drug is called Anascorp and it's made by the Mexican company Instituto Bioclon. Every year there are about 250 severe, potentially fatal scorpion stings in the United States. Most of those stung are children in Arizona.

"This product provides a new treatment for children and adults and is designed specifically for scorpion stings,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Scorpion stings can be life-threatening, especially in infants and children.”

Without antivenom patients, with bad stings have to be heavily sedated and placed on ventilators. Dr. Andreas Theodorou is a pediatrician who participated in the clinical trial of Anascorp.

"We infuse the drug, four hours later the symptoms have subsided and the kids can go home," Theodorou said.

Anascorp is effective against the bark scorpion, a species the United States has in common with Mexico. The scorpion is small and blonde colored and lives mainly in Arizona but has also been found in New Mexico and southern Nevada.

Toxicologists refer to the American southwest as the "Venom Belt". The region is home to thousands of venomous animals, some which can be extremely dangerous to humans.

The shortages are due to economics.

Because there is little economic incentive for drug companies to produce it, there is a worldwide shortage of antivenom. Like vaccines, antivenom is expensive to make and there simply aren't enough patients to guarantee a profit for a drug company.