In Short

Published on September 26, 2018

FDA warns of risk from hormone products

People can develop reproductive problems when exposed to synthetic hormone products used to breed swine and horses.

Over the past 30 years, 137 people have reported adverse effects after accidental contact with altrenogest products, according to a warning to veterinarians from the Food and Drug Administration. The drug is used to suppress estrus in mares and synchronize estrus in gilts, and it can be absorbed through intact human skin, agency information states.

Many of the 115 women and girls exposed reported abnormal or absent menstrual cycles, and many of the 22 men exposed reported decreased libido. Other symptoms included headache, fever, abdominal pain, nausea, diarrhea, vomiting, and rashes, FDA information states.

All reports since 1987 were connected with two Merck Animal Health products. More than 90 percent involved horse-use Regumate, and the rest involved swine-use Matrix.

The FDA's warning contains more information on handling and risks.

FDA extends comment period on heartworm drug studies

Food and Drug Administration officials want help developing ways to evaluate heartworm preventive drugs.

Those who have ideas on study designs can submit comments under docket number FDA-2018-N-1558. FDA officials announced May 24 they would collect comments through Aug. 22, but they since have extended the deadline to Nov. 20.

By Aug. 20, the agency had received one extension request and four comments, two of which provided detailed suggestions on study methods and objectives. The Animal Health Institute, which represents companies that make animal drugs, sent the extension request, stating that technical experts needed more time to gather data, confer, and write their responses.

Companies developing heartworm drugs are required to conduct dose confirmation studies in two laboratories, with separate investigators, and to conduct a field study where heartworm disease is endemic. The request published in May states that each study type includes limitations.

Dr. King's homeopathic products recalled because of contamination

The Food and Drug Administration is warning consumers not to use Dr. King's drug products, including homeopathic drug products, made by King Bio Inc. of Asheville, North Carolina. These products may pose a safety risk to people and pets because of microbial contamination identified at the manufacturing site. King Bio manufactures products for people and pets, with the recalled products including pet products for urinary incontinence and digestion relief. See the full list of recalled products. The FDA has not approved any products labeled as homeopathic, which means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness.

USDA announces detection of atypical BSE

On Aug. 29, the Department of Agriculture announced an atypical case of bovine spongiform encephalopathy in a 6-year-old mixed-breed beef cow in Florida. The animal was never brought to slaughter. The National Veterinary Services Laboratories of the USDA Animal and Plant Health Inspection Service confirmed that the cow tested positive for atypical H-type BSE. The animal was initially tested at the Colorado State University Veterinary Diagnostic Laboratory as part of routine surveillance of cattle that are deemed unsuitable for slaughter. Of the five previous U.S. cases of BSE, the first was a case of classical BSE in a cow imported from Canada. The primary source of infection for classical BSE is feed contaminated with the infectious prion agent. The rest of the cases were atypical BSE, which seems to arise rarely and spontaneously in all cattle populations.

Related JAVMA content:

FDA seeks comments on approaches to evaluating new heartworm drugs (July 15, 2018)