HANDS OFF Safety Alert: US Food and Drug Administration reports potential health risks to people exposed to altrenogest products for horses

The following warning was issued today by the FDA's Center for Veterinary Medicine in Rockville, Maryland:

The U.S. Food and Drug Administration is alerting veterinary medical professionals, as well as those who work with horses, that a synthetic progesterone product commonly used in these animals may cause reproductive system disorders and other adverse effects in people who become exposed to the drug. The FDA is providing this alert because of the nature of the adverse events, some of which have occurred in teenage girls.

Beyond Navicular Disease: Racing Commissioners Call for Regulation of Bisphosphonates in Sale Horses

Portions of the following information is edited from a press release:

The Association of Racing Commissioners International (ARCI) is formally calling for the independent regulation of the breeding and sales industries, including regulation of the class of drugs known as bisphosphonates, which are approved by the US Food and Drug Administration (FDA) for the treatment of navicular disease.

Navicular Syndrome: Does FDA Approval of Tildren and Osphos Change Anything?

From bone to zone: Focus on navicular-type lameness has evolved from concentrating on identifying bone defects visible in radiography to a more dynamic approach to also detect possible soft tissue injury, deteriorating hoof condition and age- or sport-related stress factors. The navicular bone is circled in this distal limb bone model at the University of Nottingham Vet School.

The landscape of treatment options for equine navicular syndrome is set to change this year, as the U.S. Food and Drug Agency (FDA) recently approved two drugs for use in the treatment of this complex lameness problem in the horse's foot. "Tildren" and "Osphos" are two specific medications that cleared the difficult hurdles of the FDA approval process in May 2014.

AAEP Statement on FDA Withdrawal of Pergolide for Human Use: Will It Still Be Available for Horses?

The American Association of Equine Practitioners (AAEP) has issued this statement to its members about the potential crisis of pergolide's removal from the drug market.

"As you may be aware, the FDA has withdrawn the drug pergolide from the market for use in humans. In order for the drug to continue to be available for use in veterinary medicine, the FDA must approve an exception for pergolide to be used by veterinarians and to be compounded in bulk quantities.

"The AAEP, through its Drug Compounding Task Force, has been in contact with the FDA, and they are aware of the significant impact of pergolide’s withdrawal from the market on equine medicine. The FDA Center for Veterinary Medicine is working with its counterpart for human medicine, the Center for Drug Evaluation and Research, to allow importation of pergolide for use by compounding pharmacies. The FDA expects to have an official announcement by the end of this week.

"The AAEP will continue to communicate with the FDA on this issue."

Note to blog readers: Pergolide is a drug that has been found to have some problems in human use; it is often prescribed for Parkinson's disease. Pergolide has been very helpful to some older horses suffering from problems like Cushings disease or insulin resistance that may have laminitis as a side effect. Many horse owners are concerned about a shortage of the medication for their horses.

Please read my original post from March 30 for more information.