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Parker & Waichman, LLP Attorneys at Law
Children’s Motrin Information Guide
The Case Against Children’s Motrin:
Manufacturer:
McNeil Consumer
Products
Generic Name:
Ibuprofen
Date Approved:
June 15, 1998
Status:
On the market
Approved Uses:
Pain relief
Serious Side Effects:
Allergic reaction
Blindness
Stevens-Johnson
Syndrome
Rash
Blisters
Red splotches on the
skin
Persistent fever
Swelling eyelids
Flu-like symptoms
Heart attack
Related Topics:
Advil
Stevens Johnson
Syndrome
Heart Attacks
A 7-year-old girl sued the maker of Children's Motrin for failing to
label the over-the-counter pain reliever with a warning that it could
cause an allergic reaction that caused her blindness. The lawsuit
states that the child 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.
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.
Other side effects of Stevens-Johnson-Syndrome are: a rash,
blisters or red splotches on the skin, a persistent fever, swelling
eyelids, and flu-like symptoms.
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.
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.
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Children’s Motrin (Ibuprofen)
From Wikipedia, the free encyclopedia.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) widely marketed under various
trademarks including Act-3, Advil, Brufen, Motrin, Nuprin, and Nurofen; a standing joke about
some athletes' regular use has produced "Vitamin I" as a slang term for it. It is used for relief
of symptoms of arthritis, primary dysmenorrhoea, and fever; and as an analgesic, especially
where there is an inflammatory component. Ibuprofen was developed by the research arm of
Boots Group.
Clinical use
Low doses of ibuprofen (200 mg, and sometimes 400 mg) are availble over the counter (OTC)
in most countries. Ibuprofen has a dose-dependent duration of action of approximately 4–8
hours, which is longer than suggested by its short half-life. The recommended dose varies
with body mass and indication. Generally, the oral dose is 200–400 mg (5–10 mg/kg in
children) every 4–6 hours, up to a usual maximum daily dose of 800–1200 mg. Under medical
direction, a maximum daily dose of 3200 mg may sometimes be used.
Indications
Approved clinical indications for ibuprofen include:
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Rheumatoid arthritis (DMARDs should also be considered)
Osteoarthritis, ibuprofen can reduce pain and, if present, joint inflammation
Juvenile rheumatoid arthritis, alone or with corticosteroids
Morbus Bechterew (spondylitis ankylosans) together with corticosteroids
Rheumatic fever, together with antibiotic therapy
Acute gout attack, ibuprofen is not useful for chronic treatment
Primary dysmenorrhoea (ibuprofen proved superior to placebo and propoxyphen, and
at least as effective as aspirin)
Fever
Pericarditis, chiefly after myocardial infarction, to reduce pain, fever and inflammation
Minor aches and pains such as toothache, backache, fever and pain associated with
common flu, symptomatic relief of influenza, shingles, and postoperative pain
Sporting injuries and pain after mild to moderate trauma
Headache including mild to moderate migraine attack
Off-Label and investigational use
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As with other NSAIDs, ibuprofen may be useful in the treatment of severe orthostatic
hypotension (PMID 7041104)
In some studies, ibuprofen showed superior results compared to placebo in the
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prophylaxis of Alzheimer's disease, when given in low doses over a long time (PMID
16195368). Further studies are needed to confirm the results, before ibuprofen can be
recommended for this indication.
Ibuprofen has been associated with a lower risk of Parkinson's disease, and may delay
or prevent Parkinson's disease. Aspirin, other NSAIDs, and acetaminophen had no
effect on the risk for Parkinson's (PMID 16240369). Further research is warranted
before recommending ibuprofen for this use.
Mechanism of action
Ibuprofen is an NSAID which is believed to work through inhibition of cyclooxygenase (COX);
thus inhibiting prostaglandin synthesis. As with other NSAIDs, ibuprofen inhibits platelet
aggregation, but is not used therapeutically for this action since it is a minor and reversible
effect.
Adverse effects
Ibuprofen appears to have the lowest incidence of gastrointestinal adverse drug reactions
(ADRs) of all the non-selective NSAIDs. However, this only holds true at lower doses of
ibuprofen, so over-the-counter preparations of ibuprofen are generally labelled to advise a
maximum daily dose of 1.2 grams.
Cardiovascular risk
Along with several other NSAIDs, ibuprofen has been implicated in elevating the risk of
myocardial infarction, particularly among those chronically using high doses. (Hippisley-Cox &
Coupland, 2005)
Stereochemistry
Ibuprofen, like other 2-arylpropionate derivatives (including ketoprofen, flurbiprofen, naproxen,
etc) contains a chiral carbon in the α-position of the propionate moiety. As such there are two
possible enantiomers of ibuprofen with the potential for different biological effects and
metabolism for each enantiomer.
Indeed it was found that (S)-(+)-ibuprofen (dexibuprofen) was the active form both in vitro and
in vivo.
It was logical, then, that there was the potential for improving the selectivity and potency of
ibuprofen formulations by marketing ibuprofen as a single-enantiomer product (as occurs with
naproxen, another NSAID).
Further in vivo testing, however, revealed the existence of an isomerase which converted (R)ibuprofen to the active (S)-enantiomer. Thus, due to the expense and futility that might be
involved in marketing the single-enantiomer, all ibuprofen formulations currently marketed are
a racemic mixture of both enantiomers.
Human toxicology
Only limited experience in human overdose exists. Usually, the severity of symptoms varies
with the ingested dose and the time elapsed. However, individual sensitivity plays an
important role. Human response in cases of overdose ranges from absence of symptoms to
fatal outcome in spite of intensive care treatment. Most symptoms are an excess of the
pharmacological qualities of ibuprofen and include abdominal pain, nausea, emesis,
drowsiness, dizziness, and nystagmus. GI-bleeding is possible. In addition other adverse
effects such as headache, tinnitus, central nervous depression, seizures, hypotension,
bradycardia, tachycardia, and atrial fibrillation may occur. Rarely have been reported :
metabolic acidosis, coma, acute renal failure, fluid and sodium retention with edema,
hyperkalema, apnea (chiefly in young children), respiratory depression, and respiratory arrest.
Cyanosis has been seen in a few cases. Generally, the symptoms observed with an overdose
of ibuprofen are similar to the symptoms caused by overdoses of other NSAIDs.
Little correlation between severity of symptoms of overdose and measured plasma levels
exist. Critical doses are between approximately 100 mg/kg and 800 mg/kg; the latter dose
does not indicate that the clinical course is lethal in any case. It should be noted that a
therapeutical single dose is 5 to 10 mg/kg. Therefore the therapeutic index varies between 10
and 160, but it is not possible to determine a precise LD50 as the lethal dose varies with age,
weight, and concomitant diseases of the individual patient.
Therapy is largely symptomatic. In early cases emesis should be induced. Also, gastric
lavage can be beneficial. In any case activated charcoal should be administered repeatedly to
absorb the drug before it can enter the systemic circulation. Standard measures to maintain
normal urine output should be instituted. Since ibuprofen has acidic properties and is also
excreted in the urine, forced alkaline diuresis may be useful. Symptomatic therapy of
hypotension, GI bleeding, and acidosis may also be indicated. Usually, close monitoring in an
intensive care unit for several days is indicated and necessary. If a patient survives the acute
intoxication, he/she will usually experience no late sequelae.
If you or a loved one has been injured by Children’s Motrin, Parker & Waichman, LLP will
evaluate your case for free. Click here for a free, no obligation, case evaluation.