Motrin for children with Warnings

Mommyof3

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One girl who took Motrin and already become blindness.
Read more about it...

LOS ANGELES, California (Reuters) -- A 7-year-old girl on Tuesday sued the maker of Children's Motrin for failing to label the over-the-counter pain reliever with a warning that it could lead to an allergic reaction that caused her blindness.

The lawsuit filed in Los Angeles Superior Court alleges that Sabrina Brierton Johnson suffered from Stevens-Johnson Syndrome, a potentially fatal rash of the skin and mucous membranes which caused her to go blind.

"As the makers of Children's Motrin products, we are deeply concerned with all matters related to our products and we are investigating the situation," said Bonnie Jacobs, a spokeswoman for McNeil Consumer & Specialty Pharmaceuticals, the Johnson & Johnson subsidiary that makes Motrin.

The company would not comment on the litigation, except to say that the company is aware of the situation with the girl.

Jacobs said the company is still getting a lot of information about the matter and was unable to comment further.

Dr. Stephen Setter, assistant professor of pharmacotherapy at Washington State University, said Stevens-Johnson and Toxic Epidermal Necrolysis, a related ailment, are very rare. There are about two to three cases per million people annually in Europe and the United States, he said.

Ibuprofen, a widely used pain reliever, is the active ingredient in Motrin, Advil and a variety of medicines. The condition occurred with users of the antibiotic Bactrim, pain reliever Bextra and a variety of other drugs as well as ibuprofen.

"Ibuprofen is a very useful drug and works very well in kids, in adults and geriatrics as well," Setter said. "It would cause undue alarm if they had an image of Stevens-Johnson in their heads every time they look at an Advil bottle."

The condition is characterized by a rash, blisters or red splotches on the skin, a persistent fever, swelling eyelids, and flu-like symptoms.

"I would like to warn all the parents out there that we followed all directions for this product. The result is that for 16 months my child has been tortured," Sabrina Brierton Johnson's mother Joan Brierton Johnson said at a press conference.

In addition to her blindness and several eye surgeries, Sabrina Brierton Johnson is now extremely sensitive to sunlight and must be covered up to go outdoors, her mother said.

The lawsuit comes as pain relievers, both prescription and over-the-counter, face more scrutiny over their safety in the wake of Merck & Co. Inc.'s recall of Vioxx in September and recent studies that showed risks with Pfizer Inc.'s Celebrex and over-the-counter drug naproxen.

In addition to damages, the lawsuit calls for Children's Motrin to be removed from the market until it carries a warning label detailing the risk of Stevens-Johnson Syndrome and describing its symptoms.

"This is the equivalent of a medical tsunami -- there was no warning put out whatsoever on this apparently benign, over-the-counter medicine," Sabrina Brierton Johnson's attorney Browne Green said.

He said the drug's label included a warning of the allergic risk when it was sold on a prescription basis, but the warning was removed when over-the-counter sales began in 1995.

Jean McCawley, founder of Stevens-Johnson Foundation whose daughter suffers from the condition, said cases are typically under-reported to the Food and Drug Administration because there is no mandatory reporting system for adverse drug reactions.

The lawsuit also lists as defendants the retailers and wholesalers that distributed the product: McKesson Corp. , Cardinal Health Inc., Albertsons Inc.'s SAV-ON Drug Stores unit and Kroger Co.'s Ralphs Grocery Company.

this is from Cnn.com

That is so scary for make mistake to give child if she or he get Allegery or Worse like Serious illness or death.
Wow, I learn something about it but thanks god my children have no allegeries.
Mommyof3
 
If I had a baby, I would have tests done to make sure we don't give the baby anything wrong.
 
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