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Posted: 12/30/2004 9:51:49 AM EDT

Lawsuit: Children's Motrin Causes Severe Side-Effects
California Couple Sues Maker, Distributors Of Painkiller

POSTED: 10:33 pm EST December 28, 2004
UPDATED: 10:34 pm EST December 28, 2004

LOS ANGELES -- A California couple is suing the maker of Children's Motrin, claiming the painkiller caused their 7-year-old daughter's blindness.

The family accuses McNeil Consumer and Specialty Pharmaceuticals of concealing potential health risks. McNeil is a subsidiary of Johnson & Johnson. Several other firms that distribute the medication are also named in the suit.

The girl's parents are seeking unspecified compensatory and punitive damages.

According to the suit, the day after the girl took Children's Motrin drops she awoke with a high fever and other symptoms, and lost her eyesight in both eyes within a couple of days.

According to the suit, doctors later concluded the girl had contracted Stevens-Johnson Syndrome -- which is typically caused by an adverse reaction to a drug or virus.


Children's Motrin Containers May Contain Adult Tylenol
Two Mislabeled Bottles Identified So Far

POSTED: 7:25 a.m. EDT May 13, 2004
UPDATED: 3:47 p.m. EDT May 13, 2004

FORT WASHINGTON, Pa. -- Bottles that were supposed to contain Children's Motrin grape chewable ibuprofen tablets might mistakenly contain an adult dose of a different kind of over-the-counter painkiller.

McNiel Consumer and Specialty Pharmaceuticals says the bottles might mistakenly contain eight-hour extended release Tylenol Geltabs.

The adult product contains an adult dose of acetaminophen.

So far, two mislabeled bottles have been identified, but no injuries have been reported as a result of this issue.

The children's product is a round, purple tablet with a grape smell with the letters MO and the number 50 on the tablet surface. The adult product is a shiny red-and-white, gelatin-coated tablet with "8 Hour" printed in blue on either the red or the white side. See pill comparison below.

The suspect bottles were distributed nationwide to wholesale and retail customers between Feb. 5 and April 1.

The bottles are labeled as containing 24 tablets, and the manufacturing lot number is "Exp 1/06 JAM108." Anyone identifying one of the bottles is asked to contact McNeil's Consumer Relationship Center at (800) 962-5357. Parents who believe their children may have taken Tylenol 8-Hour Geltabs, believing them to be Children's Motrin Grape Chewable Tablets, should contact their doctor immediately.

According to the American Academy of Pediatrics, a child acetaminophen overdose can lead to nausea and vomiting, abdominal pain and liver failure.

For more information, call (800) 962-5357 or visit motrin.com.

Thought you all would want to know. Watch what your child takes. I am sure most of you do, but felt we have to keep up on these things.
Link Posted: 12/30/2004 10:00:05 AM EDT
I had always preferred Motrin over Tylenol. All I had in the house was motrin... quick trip to the store, we have tylenol, quick pitch to the trash can, we are out of motrin. I use any medication for lilGH sparingly, but I won't take chances. Thx Joyce.
Link Posted: 12/30/2004 10:02:43 AM EDT
That was basically my point.

There are risks with all meds. Some just aren't worth taking.

God bless,
Link Posted: 12/30/2004 11:29:51 AM EDT
[Last Edit: 12/30/2004 11:42:16 AM EDT by Persephone]
More, since it 'tis the season.  


Gotta be careful w/ Tylenol too.  Acetaminophen is in a lot of OTC medicines and you could accidentally over-dose so be sure to read the packages carefully.

Also, it may actually prolong the illness.  Here's a study on it's use in chickenpox:


Acetaminophen: more harm than good for chickenpox?

Doran TF, De Angelis C, Baumgardner RA, Mellits ED.

Department of Pediatrics, Johns Hopkins Medical Institutions, Baltimore.

STUDY OBJECTIVE: To determine whether acetaminophen affects the duration or severity of childhood varicella. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Office- and hospital-based pediatric practices. PATIENTS: Seventy-two children between 1 and 12 years of age entered the study. One child was withdrawn because of high fever, and three children did not complete the study; 31 received placebo and 37 received acetaminophen. INTERVENTIONS: Acetaminophen, 10 mg/kg/dose, was given at 8 AM, 12 PM, 4 PM, and 8 PM for 4 days. Placebo was given to the control group. Itching, appetite, activity, and overall condition were measured for 6 days. The time to last vesicle formation, time to total scabbing, and time to total healing were measured until complete resolution of the exanthem. MEASUREMENTS AND MAIN RESULTS: The following results were better in the placebo group (p less than .05): time to total scabbing 5.6 days (SD 2.5) versus 6.7 days (SD 2.3) in the acetaminophen group, and itching on day 4 in the placebo group (symptom score 2.9 (SD 0.20) vs 2.2 (SD 0.26]. Activity was better in the acetaminophen group on day 2 (3.13 (SD 0.23) vs 2.82 (SD 0.24]. CONCLUSIONS: These results provide evidence that acetaminophen does not alleviate symptoms in children with varicella and may prolong illness.

Wonder if it has the same effect on other viruses?  

Edit:  Oops!  Found the answer to my own question....

Aspirin And Tylenol May Prolong The Flu

Link Posted: 12/30/2004 12:31:10 PM EDT
Link Posted: 12/30/2004 3:59:22 PM EDT
I use Motrin for my daughter, but I do and will continue to, monitor her closely when I give it to her. Thanks for the F.Y.I. It never hurts to be informed, and careful.
Link Posted: 12/31/2004 7:04:27 AM EDT
[Last Edit: 12/31/2004 7:17:13 AM EDT by Ogre_4070]
All medications can be dangerous if not given and monitored properly.  That said, after reading the article about this child I would be very hesitant to give it to my child.  What this child has gone through is horrific.


Parents of stricken girl sue makers of Children's Motrin


By Linda Goldston

Mercury News

The parents of a 9-year-old Saratoga girl have sued the makers of Children's Motrin, claiming the flu and pain medication caused the extreme allergic reaction that left their daughter, Kaitlyn Langstaff, unable to see, speak or eat.

The lawsuit filed in U.S. District Court in San Jose also alleges that the manufacturer of the drug failed to adequately test it for over-the-counter use with children and failed to warn the public of potentially fatal reactions to Children's Motrin.

``They knew it could cause this terrible toxic epidermal necrolysis and didn't tell the FDA, didn't tell the public and fraudulently put it on the market as safe,'' said San Francisco attorney Mary Alexander, one of the lawyers representing Kaitlyn's parents, Kerry and Bradshaw Langstaff.

Named in the suit are Johnson & Johnson and a subsidiary, McNeil Consumer & Specialty Pharmaceuticals. Company representatives could not be reached for comment.

Kaitlyn's determination to remain a normal child despite her debilitating disease has made her something of a local celebrity. After the Mercury News published her story and a poem she wrote, a rock promoter arranged for her poem to be set to music, recorded on a CD and performed at a benefit concert in her honor on March 1.

The lawsuit, which was filed Friday just over 11 months after Kaitlyn became ill, does not specify the amount of damages being sought but does request a jury trial.

``The manufacturer doesn't warn about it, although there is a clear association in the medical literature between Stevens Johnson Syndrome and TENS and ibuprofen, the generic form of Children's Motrin,'' said James C. Barber, a Dallas attorney who is also representing the Langstaffs. ``They clearly have known about the problem.''

Contact Linda Goldston at lgoldston@mercurynews.com or (408) 920-5862.    Kerry Langstaff, who has spoken extensively about Kaitlyn's struggles, said the family had been advised by their attorneys ``not to comment at this time.''
According to the suit, Kaitlyn had no known allergies when she was given Children's Motrin for fever and sore throat by her parents on April 6.

``The next day she broke out in a rash,'' the suit states. ``She continued to take the drug every 4-6 hours when she sought care at Fresno's Children's Hospital where she was diagnosed with toxic epidermal necrolysis.''

On the third or fourth night in the pediatric intensive care unit in Fresno, ``a physician at the hospital recommended discontinuation of the drug,'' according to the suit. Kaitlyn was then transferred to Children's Hospital in Los Angeles and later to Lucile Salter Packard Children's Hospital at Stanford and then Santa Clara Valley Medical Center.

Kaitlyn, who turned 9 on Feb. 25, was hospitalized for 110 days and nearly died several times.

``During her hospitalization, she was in excruciating pain caused by her skin sloughing off her body, comparable to second degree burns,'' the suit says, ``but since they were not full thickness burns, all nerve endings were exposed, leaving her in terrible pain . . . Because of the loss of her skin and blood, she suffered secondary infections and massive bleeding, requiring multiple blood transfusions; all of which required her to be heavily sedated and restrained to her bed.''

The condition caused massive scarring in Kaitlyn's lungs and airway, requiring that a tube be inserted in her throat so she can breathe. She has a feeding tube in her stomach and needs a wheelchair to get around. She is blind and needs an electronic larynx to speak.

``She will require multiple additional surgeries in the future, and permanent and possibly full-time medical and custodial care for her catastrophic injuries,'' the suit states.

After Kaitlyn's story was published in the Mercury News last year, hundreds of people stepped forward to help, offering everything from money to repairs for the family's leaky roof. Both parents were laid off from their high-tech marketing jobs the summer before Kaitlyn became ill and have been unable to find new ones.
Link Posted: 12/31/2004 11:19:36 AM EDT
Thank you for posting the update. How very sad. We will keep her in our prayers,...
Link Posted: 1/11/2005 3:19:39 PM EDT
well a child can have a reaction to anything at anytime. my doctor prefers motrin in most cases for fever and aches and pains. tylenol justdrops a fever and stops some pain. i use to be a paramedic and found more problems with kids when there accidently overdosed with tylenol than motrin. now i'm a lpn now and the big scare over motrin is reyes syndrome. now alot of families rather not treat there children due to the potential and let there kids suffer. i'm one who reaches for motrin first when my kids are sick. (daughter 11, son 8).
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