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Children's Motrin®

January 4, 2021

On April 30, 2010, unexpired lots of Children's and Infants' liquid Motrin® were recalled by the U.S. Food and Drug Administration (FDA) and the products' manufacturer. The manufacturer, McNeil Consumer Healthcare, said in a press release that the recall was voluntary because "some of these products may not meet required quality standards." McNeil Consumer Healthcare, a division of McNeil PPC, Inc., is a subsidiary of Johnson & Johnson.

The press release went on to say that the recall was not due to the occurrence of adverse medical events, but as a precautionary measure because:

  • Some of the products may contain a greater concentration of active ingredients than indicated
  • Some may contain inactive ingredients that did not meet internal quality standards
  • Some may contain tiny particles

The release did not state what the tiny particles consisted of.

What is Children's Motrin® Used For?

Children's Motrin® is classified as a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, pain, inflammation and swelling caused by a variety of medical conditions. The manufacturer states there are certain increased risks associated with long-term use of NSAIDs. These risks include:

  • Heart attack
  • Stroke
  • Stomach bleeding, especially if more than one type of NSAID is taken at a time or if someone has more than three alcoholic drinks daily

Children's Motrin® and Stevens-Johnson Syndrome

NSAIDs also have been linked to a rare, allergic skin disorder named Stevens-Johnson Syndrome (SJS). The disorder affects all ages. This is a life-threatening condition that is characterized by:

  • Red and purple rash that appears in the form of a flat target
  • Blisters that form as the rash's splotches merge and becomes raised
  • The blisters and surrounding skin eventually slough off
  • Blisters may also form on the mucous membranes of the eyes, ears, mouth, nose, throat and genitalia

Before the rash and flaking skin appear, SJS patients typically feel like they're coming down with the flu. They may have a fever, sore throat, body aches, headache and cough. The face and tongue swell. The affected skin may be confined to one area or cover most of the body surface.

The condition is similar to a severe thermal burn and patients are best treated in a hospital burn unit where they can receive intravenous fluids, salts and nourishment. The raw areas of skin where the upper layers of tissue have sloughed off are covered with cool soothing compresses.

It is essential to prevent the wounds from becoming infected, since the infection could become systemic and eventually cause organ failure and death.

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