Researchers with Pediatrix Medical Group analyzed data from 49,777 infants born between 2003 and 2008 with a birth weight of 501-1,500 grams – or 1 to 3 pounds. The goal of the study was to determine the effectiveness of a multi-faceted quality improvement intervention in reducing the use of many medications that have not been adequately studied in this group, that have not demonstrated clinical benefits, or that carry adverse effects to neonatal patients. The medications targeted were the antibiotic cefotaxime, gastrointestinal medications metoclopramide and H-2 blockers, the diuretic spironolactone, and the hormone erythropoietin.

Metoclopramide, known by the brand name Reglan, has never been approved by the Food and Drug Administration (FDA) for use in premature infants. It is prescribed to patients to treat severe heartburn or gastroparesis, a delayed emptying of the stomach contents. The drug carries a black box warning that long-term use (12 weeks or greater) significantly increases one’s risk of a serious and debilitating movement disorder known as Tardive Diskineia.

The study compared baseline medication usage in 2003 to post-intervention usage in 2008. Following the quality improvement intervention initiatives from 2005-2007, researchers found that use of the targeted medications was significantly reduced.

SOURCE: Reglan Side Effects › Quality improvements reduce drug usage among neonatal community

Last month, the FDA issued a black box warning on the injectable form of promethazine hydrochloride. Promethazine hydrochloride, once sold under the now-discontinued brand name Phenergan, is available in generic formulations in the form of tablets, liquid, rectal suppository, intravenous injection and intramuscular injection. The black box warning cautions health care providers against administering the IV injection into an artery or under the skin because gangrene or other severe tissue injury can result. It also can leach out from the vein during IV administration, causing serious tissue damage.

Another anti-nausea medication is metoclopramide, known by the brand names Reglan and Metozolov. The drug can be administered by injection, or taken as a pill by mouth. Metoclopramide is also a treatment for gastrointestinal conditions such as gastroparesis and GERD. Earlier this year, an FDA black box warning was placed on metoclopramide after long-term use of the drug was linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia.

Tardive Dyskinesia is identified by involuntary head jerking, eye blinking, facial grimacing, pucker and pursing of the lips, lip smacking and tongue thrusting. It may also involve involuntary movements of the fingers and hands. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

SOURCE: Reglan Side Effects › Anti-nausea drugs carry black box warnings