Shortage of injectable levothyroxine sodium

The American Society of Health-System Pharmacists reports a shortage of injectable levothyroxine sodium. This drug shortage has occurred because the sole supplier, APP, has experienced manufacturing delays after the switch in 2011 from its grandfathered, FDA-unapproved product to FDA-approved injectable levothyroxine sodium. The FDA has been very incremental in its approach to insisting that drugs in use before 1938, and another group in use before 1962, meet modern drug standards, but the process continues in this instance.

The importance of this injectable formulation is its use for a severe manifestation of hypothyroidism called myxedema coma or crisis. Poorly controlled hypothyroidism and stress can bring on the crisis calling for injection of levothyroxine sodium, and the symptoms may include generalized swelling under the skin (myxedema) and coma. This is a potentially lethal situation requiring immediate emergency care. Some symptoms that will probably manifest before the coma are hallucinations, disorientation, seizures, low body temperatures, swelling around the eyes and general swelling all over the body, difficulty breathing, fatigue, and slow and irregular heartbeats. Women over sixty years of age are particularly affected.

Shortage of injectable levothyroxine

The American Society of Health-System Pharmacists reports a shortage of injectable levothyroxine in the form of the sodium salt. This drug shortage is important to anyone who can't take the tablet forms of the drug. Adults can tolerate a shortage of this thyroid hormone, if it isn't long-term. Infants and children with insufficient or absent thyroid function must have this hormone to thrive and maintain the proper rate of growth and development. APP Pharmaceuticals is the only approved US supplier, and they were originally supplying an unapproved version which was legal because it was "grandfathered" under the laws governing the FDA. Since about 2006, the FDA has prioritized approvals of these older drugs based on their assessment of the risk involved with using the drugs and on any complaints made about them. The new presentations of levothyroxine sodium for injection were approved in July 2011, and this shortage seems to be a short-term problem with distribution.