Animal & Veterinary
Steps Taken To Avert Shortage of Injectable Drug for Pigs
by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No V
Because of the shortage of the drug, iron dextran, the Food and Drug Administration is working with sponsors to exercise discretion on a case-by-case basis over the importation into the United States of the 200 mg/mL iron dextran from foreign sources.
Injectable iron dextran is approved by FDA for the prevention and treatment of iron deficiency anemia in baby pigs. Because injectable iron dextran is considered a medically necessary drug for this indication, and a shortage could result in undue animal suffering and disruption in the swine industry, FDA is working with sponsors to make adequate supplies of the drug available to treat newborn pigs.
Iron is essential for baby pigs
Iron administration within 1 to 3 days after a pig’s birth is essential for preventing iron deficiency or anemia. Newborn pigs are very vulnerable to iron deficiency, more so than many animals, for the following reasons:
- Newborn pigs are born with only moderate stores of iron, mostly in the liver, but only enough to sustain their hemoglobin for 3 to 4 days.
- Newborn pigs grow at an extremely fast rate, quadrupling their body weight in 3 to 4 weeks. Therefore, muscle mass and blood volume increase rapidly, and the hemoglobin quickly becomes diluted in the blood.
- Milk is the only food consumed by baby pigs during the first few weeks after birth, and milk is not a good source of iron; a quart of milk contains only about 1 mg of iron. Pigs require 7 to 8 mg of iron every day.
- Pigs are raised in an environment where they cannot get iron from other sources (e.g., nuzzling in the soil) because the floors are concrete, steel, rubber, or plastic.
All of this stated, it is important to note that no more than 200 mg of iron should be given to pigs. Higher levels of iron encourage systemic bacterial growth and can lead to diarrhea and possible toxicity.
FDA’s imported drug restrictions
Section 301 of the Federal Food, Drug, and Cosmetic Act prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs, whether for personal use or otherwise, that lack FDA approval, violates the Act. Unapproved new animal drugs are any drugs, including foreign-marketed versions of U.S.-approved drugs, which have not been manufactured in accordance with, and pursuant to, an FDA approval.
Unapproved drugs are considered unsafe, and therefore adulterated, under the Act. Under the Act, FDA may refuse admission to any drug that “appears” to be adulterated. The burden is on the importer to prove that the drug sought to be imported is in fact approved by FDA. Absent evidence that the specific drugs sought to be imported from a foreign country have been manufactured pursuant to an approved new drug application in the manufacturing facility permitted under the application, such drugs would appear to be adulterated and could be refused admission to the United States.
CVM is committed to working with sponsors to ensure that an adequate supply of injectable iron dextran product is available. More information is available on CVM’s Web site.