FDA warns of danger from drug> Unapproved substance poses risk of infection

WASHINGTON — The Food and Drug Administration issued a nationwide alert Friday, warning of severe infection risk from an unapproved injection drug extracted from the adrenal gland of cattle, sheep and pigs.

The FDA said that at least 54 people have contracted serious bacterial infections after receiving injections of a substance called adrenal cortex extract. The preparation is distributed by Phyne Pharmaceuticals of Scottsdale, Ariz., and is labeled Hallmark Labs Inc., the agency said.

Brad Stone, an FDA spokesman, said the preparation is not approved for any use and has not been shown to be effective for treatment of any medical condition. Yet, it is being promoted as a drug for weight loss, burn treatment and for lessening substance abuse addictions.

The preparation has been linked to serious bacterial abscesses at the injection sites. Seventeen patients have had to undergo surgical incisions to drain abscesses.

“It can be life-threatening” said Stone, particularly for people who have weak or ineffective immune systems, such as patients with AIDS.

The FDA said that the adrenal cortex extract is taken from the glands of livestock and may be contaminated.

“Physicians or consumers who have adrenal cortex extract products bearing `Hallmark Labs’ on the label should immediately stop using the product,” the FDA announcement said. Patients who have experienced swelling at the injection site, along with other signs of infection, should seek medical treatment immediately, the agency said.

It also asked people who have the injectable product to call the FDA at (714) 667-7416.

The Morbidity and Mortality Weekly Report, a publication of the Centers for Disease Control and Prevention, said last week that the adrenal cortex extract was injected into 68 patients by a Denver physician who was promoting the product for weight loss. By Aug. 7, the CDC said, 47 of those patients developed abscesses of up to 1.5 inches in either the buttocks or the arm, whichever was used as the injection site.

A fast growing bacteria, called Mycobacterium abscessus, has been isolated from unopened vials of the product.