The pharmaceutical company Lundbeck of Deerfield, Illinois recently announced a voluntary recall of NeoProfen, an injectable form of ibuprofen used for treating premature infants. The drug maker issued the recall due to visible particulates in the NeoProfen solution, Pharm Tech Talk reported.
The drug is used to treat a heart condition in premature infants known as patent ductus arteriosus. Lundbeck admitted in its recall notice that “The potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal,” the Pharm Tech Talk article reported.
Lundbeck has not yet received any notices of adverse effects from the use of NeoProfen, according to the recall notice statement. The FDA, wholesalers of the drug, hospitals and neonatologists have all received notification of the recall. Lundbeck reports that there will be a short-term shortage of NeoProfen while the company finishes the recall and manufactures new supplies, the Pharmaceutical Business Review reported.
Potential problems that could arise due to injections of a solution with visible particulates include obstruction of blood vessels, pulmonary emboli, anaphylactic shock, foreign body granulomas and irritation of blood vessels, according to a Med Page Today article.
Pellek, Alexis. (August 5, 2010) “Lundbeck Voluntarily Recalls Injectable Ibuprofen Used to Treat Premature Infants.” Retrieved on August 6, 2010 from Pharm Tech Talk.
Petrochko, Cole. (August 2, 2010) “Injectable Ibuprofen Recalled.” Retrieved on August 6, 2010 from Med Page Today.
Pharmaceutical Business Review Staff: (August 2, 2010) “Lundbeck Voluntarily Recalls NeoProfen Injection.” Retrieved on August 6, 2010 from the Pharmaceutical Business Review.
Photo Credit: Premie in incubator by MikeBlyth.