Yourlawyer.com (Motrin News) http://www.yourlawyer.com/topics/overview/motrin Sat, 21 Nov 2009 19:42:28 -0800 pixel-app en Two Studies Link Over-the-Counter Painkillers with Increased Risk of Developing Ulcers, Perforations, and GI Bleeding http://www.yourlawyer.com/articles/read/10885 Thu, 03 Nov 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/10885
All of these medications were found to increase the risk of gastrointestinal (GI) bleeding especially when taken with aspirin or when taken in high doses.

One study, done at the University of Utah College of Pharmacy in Salt Lake City, showed that patients, who took aspirin and OTC NSAIDs together, were two to three times more likely to develop stomach ulcers, perforations and bleeding compared to individuals who took the NSAIDs alone.

The findings were presented yesterday at the American College of Gastroenterology annual meeting in Honolulu.

Another study, conducted by Dr. Barry Bowen of McMaster University in Hamilton, Ontario and published in the November issue of Clinical Gastroenterology and Hepatology, reports that those on an ibuprofen regimen suffered four times as much blood loss from stomach ulcers and gastro intestinal problems than those individuals not taking the medication.

The researchers conducted an analysis of two random studies that considered 68 healthy subjects who were given either four weeks of an ibuprofen regimen at 800 mg, three times daily for 28 days (twice the daily recommended dosage) or a placebo.

Healthy individuals, who took the ibuprofen, had blood loss that was 3.64-fold greater than the placebo group. The bleeding started as little as three days into the study and lasted for the entire course of treatment in many individuals.

Joe Biskupiak, study author at the University of Utah College of Pharmacy, stated that the risks documented in the recent studies were not unexpected: "We know that the prescription NSAIDs increase risk. Over-the-counter NSAIDs are a little harder to pin down because it's harder to get data on patients using them. Everybody suspected it, but there hasn't been a lot out there."

He also remarked that both doctors and patients need to be educated about the gastrointestinal problems associated with the drugs. Recent findings suggest that most of the people taking pain relievers, who were at risk for bleeding, were not taking medication to prevent it. Many were also unaware of the possible negative side effects.

Several other experts also regard the new studies as “confirmatory” of the link between high-dosage, frequent, and multiple NSAID use and gastrointestinal problems. In addition, regulating OTC NSAID use “remains the most substantial modifiable risk factor to reduce gastrointestinal complications from NSAIDs," according to Dr. Mark Fendrick, professor of internal medicine at the University of Michigan School of Medicine at Ann Arbor.

The NSAID family of drugs includes Cox-2 inhibitors such as Vioxx and Bextra (now off the market) and Celebrex (still available). Those versions of NSAIDs were successful because of their less serious GI effects.

Since Cox-2 inhibitors have now been associated with an increased risk of serious cardiovascular problems, however, many patients have returned to the “non-specific” OTC NSAIDs for relief thereby significantly increasing the number of people exposed to the GI problems associated with either high-dosage, frequent, or multiple OTC NSAID use.

As Biskupiak put it: “Just because it’s over-the-counter doesn’t mean it’s devoid of risk.”]]> New Study Links Common Painkillers with Heart-Attack Risk http://www.yourlawyer.com/articles/read/9999 Thu, 09 Jun 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9999
Patients should not stop taking the drugs involved, the authors caution, but further investigation into these treatments is needed, they say.

In the biggest study of its kind to date, researchers identified 9,218 patients across England, Scotland and Wales who suffered a heart attack for the first time over a four-year period. Patients ranged in age from 25 to 100.

The investigators looked at the prescribing patterns for these patients, tracking whether and when they had been prescribed NSAIDS. This class of medications, which commonly are prescribed to relieve inflammation and pain, includes ibuprofen, diclofenac (Advil, Motrin, etc.), naproxen (Aleve, Nuprin, etc.), celecoxib (Celebrex) and rofecoxib (Vioxx) plus a host of other less commonly prescribed anti-inflammatories.

Rofecoxib is no longer commercially available, having been withdrawn from the market in 2004. NSAIDS Increased Risk

The findings were adjusted to allow for several other heart-attack risk factors including age, obesity and smoking habits. Importantly, the researchers also adjusted for whether patientd already suffered from heart disease or were prescribed aspirin.

For those who were prescribed NSAIDS in the three months just before the heart attack, the risk increased compared with those who had not taken these drugs in the previous three years, the researchers found. For ibuprofen, the risk increased by almost a quarter (24%) and for diclofenac, it rose by over a half (55%).

The newer generation of anti-inflammatories known as COX-2 inhibitors also were associated with increased rates of first-time heart attack. Those patients who were prescribed the drugs in the preceeding three months were at 21% higher risk of heart attack if taking celecoxib (Celebrex) and 32% increased risk if taking rofecoxib (Vioxx).

'Considerable Implications for Public Health'

Since this study was concluded, rofecoxib was withdrawn due to concerns over heart-attack risk. That makes the impact of this study on patients even more important, say the authors, since those previously taking rofecoxib will have turned to the other anti-inflammatories in greater numbers.

The most significant findings were for the drugs ibuprofen, diclofenac and rofecoxib, say the authors. In terms of "numbers needed to harm" in the 65 and over age group, for those taking diclofenac, one extra patient for every 521 patients was likely to suffer a first-time heart attack.

For rofecoxib, the figure was one patient for every 695 patients; and for ibuprofen, one patient for every 1,005 patients was at risk.

"Given the high prevalence of the use of these drugs in elderly people and the increased risk of myocardial infarction [heart attack] with age, the relatively large number of patients needed to harm could have considerable implications for public health," say the authors.

The nature of this report, an observational study may make it prone to other explanations for the findings, say the authors. "However, enough concerns exist to warrant a reconsideration of the cardiovascular safety of all NSAIDS," they conclude.]]> Perils of Pain Relievers Often Disguised In Tiny Type http://www.yourlawyer.com/articles/read/9690 Sun, 08 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9690
For over a century, aspirin was the pain drug of choice, until data emerged on the rather large number of bleeding-related deaths this time-honored medicine caused each year. In fact, many pharmaceutical experts say that if aspirin had to go through the Food and Drug Administration's approval process today, it would never make it to market.

Along came some dandy substitutes, now also sold over the counter under brand names and as generics: ibuprofen (Advil, Motrin IB) and naproxen (Aleve). Ibuprofen and naproxen, known as nonsteroidal anti-inflammatory drugs, or Nsaids, can equal or outdo aspirin's action against painful inflammation but at less risk of bleeding.

But they, too, can have serious side effects: They can irritate the gastrointestinal tract and possibly cause ulcers. People who use Nsaids chronically are often told to take an anti-acid drug to protect their stomachs.

This problem opened up a market for a new kind of drug called a cox-2 inhibitor, sold as Celebrex, Vioxx, Bextra and Mobic. These drugs are as good or better than ibuprofen for pain, although as patented prescription medications they greatly multiplied the cost of pain relief.

The cox-2 inhibitors were considered safer because they reduced the risks of bleeding and gastrointestinal damage. And as major money-makers, they were heavily promoted, especially to the millions who need relief for chronic problems.

Alas, these too have come under serious fire as their use mushroomed and evidence emerged linking them to heart attacks and strokes among users already at risk for these problems. With many multimillion-dollar lawsuits looming, Vioxx was the first to be withdrawn from the market, recently followed by Bextra. Both drugs may come back, accompanied by more stringent warnings. Or their cox-2 cousins, Celebrex and Mobic, may join the ranks as drugs gone by.

Problems also accompany other prescription painkillers, like the opioids.

This brings us to an entirely different drug, acetaminophen, long used to counter fever and occasional aches and pains such as tension headaches. But now acetaminophen is being hailed as an excellent first choice for the relief of chronic pain.

Acetaminophen, often referred to by its most popular brand name, Tylenol, has no anti-inflammatory action. Nor does it cause bleeding or gastrointestinal distress. Many pain specialists say it should be considered first for relief for the persistent pain of osteoarthritis and prolonged pain of muscle or joint injuries.

All in all, acetaminophen is a safe drug for children and adults. Despite the many millions of doses taken by Americans each year, few reports of serious side effects emerge when acetaminophen is used in the dosages recommended by manufacturers.

For example, in a study published a decade ago evaluating the experience of 28,130 children who had taken acetaminophen, there was no increased risk of gastrointestinal bleeding, kidney failure, life-threatening allergic reactions or Reye's syndrome, a potential fatal side effect of aspirin when given to children with viral infections.

Acetaminophen is also considered safe for women who are pregnant or breast-feeding, although they are advised to check first with their doctors. And acetaminophen is the pain reliever of choice for those with serious allergies who may be at risk of severe allergic reactions from aspirin and Nsaids.

Perhaps as a testament to its safety, acetaminophen is found not only on its own in a variety of dosages, but also in combination with other medications, over the counter and prescription. If consumers are unaware of its presence in different medications, or if they fail to adhere to cautionary statements about dosages, it is possible to take too much acetaminophen inadvertently.

As with any other medicine, with acetaminophen it is critically important to keep in mind this irrefutable adage: The dose makes the poison.

For example, no one questions the safety of following recommended doses. If you can read the fine print on the label, it will tell you that for adults and for children 12 and older, two 500-milligram tablets or capsules can be taken every four to six hours, as long as no more than eight tablets (a total of 4,000 milligrams) are taken in a 24-hour period unless a physician says otherwise.

Taking more than 4,000 milligrams a day of acetaminophen on a chronic basis can damage the liver of an adult. The danger dose would be far smaller for young children.

It is easier than you may think to take more than 4,000 milligrams a day. With the higher-dose tablets (650 milligrams each) now sold to treat arthritis, you can easily exceed the safety limit if you do not follow the instructions to take two tablets every eight hours, for a maximum daily dose of six tablets in 24 hours, adding up to 3,900 milligrams a day.

Even if you follow these directions, you can exceed the recommended daily dose if you also take another medication say, an over-the-counter cold or flu remedy that contains acetaminophen.

The label on Tylenol Arthritis Pain has a clearly stated warning: "Do not use with any other product containing acetaminophen." But without a magnifying glass, many elderly people who are the most likely users of an arthritis drug would have trouble reading the labels on this and many other medicines like it.

A second warning on acetaminophen says: "If you drink three or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage."

So, if your liver is already under attack from alcohol, acetaminophen can be that last straw, resulting in liver failure.

This year, the journal Emergency Medicine warned physicians about the hazards of overdoses of acetaminophen. Dr. Shirley Kung and Dr. Kennon Heard wrote that acetaminophen poisoning could often be much worse than it seemed at first.

Nausea and vomiting can progress to complete liver failure in as little as 24 hours unless the problem is promptly recognized and the proper antidote given within 24 hours of a toxic dose. To fully prevent liver injury, the antidote should be given within eight hours.

Each year, more than 100,000 calls related to acetaminophen are made to poison control centers in the United States, and about 150 acetaminophen-related deaths are reported. Some cases result from deliberate overdoses by people trying to commit suicide. But many others are accidental, like the one described in the journal: an 18-month-old child with a fever and cough for three days who had been given acetaminophen every two to four hours.

Other cases result when people whose livers are damaged by other disease take acetaminophen for respiratory infections or pain.]]> RADAR Finds Drug Reactions http://www.yourlawyer.com/articles/read/9692 Wed, 04 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9692
The report in the Journal of the American Medical Association is one of the results of an independent pharmaceutical surveillance program known as RADAR (Research on Adverse Drug Events and Reports Project), which looks at the safety of drugs already on the market.

The scientists from Northwestern University scoured academic journals, reports by pharmaceutical companies, and the U.S. Food and Drug Administrations database for information about adverse reactions to common drugs.

They identified reactions that affected nearly 1,700 patients, and divided them into three groups of effects: death, severe organ failure, or cases requiring major interventions like CPR or liver transplantation.

The results show that 170 people died from adverse drug reactions. One novel cancer drug alone is associated with 67 deaths.

"RADAR has proved to be a powerful new instrument that supplements existing FDA surveillance systems and has helped save hundreds to thousands of patient lives," said Charles L. Bennett, program director.

The FDA has come under fire recently for not adequately policing the safety of marketed drugs. Several drugs have been withdrawn from the market or re-labeled to warn of additional side-effects.

"Its the FDAs responsibility to make sure that the drugs which go on the market are safe and effective," said Elizabeth Boehm, a senior research analyst with Forrester.

New Jersey-based Merck withdrew its COX-2 inhibitor Vioxx on September 30, after studies showed the arthritis drug caused heart problems. Pfizer followed suit on April 7 with Bextra, and Biogen Idec and Elan suspended sales of multiple sclerosis drug Tysabri on February 28.

Suspicion has also been cast over common painkillers such as Advil, Motrin, and Aleve, as well as Scios heart drug Natrecor, and Novartis epilepsy drug Trileptal.

These have prompted calls for post-market monitoring of drugs by independent groups of scientists, such as those involved in RADAR.

According to Ms. Boehm, some drugs are approved after a very short period of testing on the condition that they are continually monitored while on the market.

"Its the follow-up on that which is under-resourced. Thats the most politically sensitive way I can put it," she said. "The FDA is not staffed to monitor all of these drugs over the long haul."

Currently, its largely up to drug companies to report safety issues once a drug is already for sale. "For good business reasons, they arent going out there to seek out every adverse drug event," added Ms. Boehm.]]> So. Cal. Woman Says Children's Motrin Blinded Her Daughter http://www.yourlawyer.com/articles/read/9683 Tue, 03 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9683
You don't hear about them, because those cases settled out of court and a gag order was imposed. But the Healthline 3 Team found one family that doesn't want to settle because they want the world to know they believe Children's Motrin cost their daughter her sight.

"I've been such a proud mom. She's been just the most delightful, gorgeous, healthy, bright, active child until this happened and now we have a sick, blind, unhappy, suffering child at home all the time." After just three doses of Children's Motrin to lower a high fever, Sabrina Johnson's mom realized something was horribly wrong. "She looked very strange, her eyes were all puffed up, her mouth was puffy and had sores and it looked sore and cracked and so at that point I immediately called the doctor."

Sabrina was diagnosed with Stevens Johnson Syndrome, or SJS, the name given when you have an allergic reaction to medicine. Sabrina is now blind, has a deficient immune system and can't tolerate light. Sabrina always wears sunglasses and a hat over her face to block out light. On bad days, she lives in the closet. "If you close all the blinds in the house, it's still not enough. She said in one interview I had my sunglasses on, a hat on my face, a blanket over my head, sitting in a closet with the door closed and I still had to try to block the light from coming in under the bottom and it wasn't enough. It hurts so much."

When we were in California, Sabrina wasn't well enough to give an interview, but her family attorney provided us with footage of her. Sabrina has already had 20 surgeries to try to help her vision. Her family is suing Johnson & Johnson for damages, but what they really want is a warning label on Children's Motrin bottles. "I really do feel like Johnson & Johnson is responsible. Number one, they put this drug out there on the marketplace initially as a prescription only drug. They had a warning with that drug so they obviously knew about these consequences, they then watered down that warning when they made an over the counter medication."

Aspirin bottles currently have a warning the drug may cause Reyes Syndrome, a rare but deadly condition. The Johnson's want a similar warning about SJS on Children's Motrin bottles. They also want the National Institutes of Health to keep records about SJS cases and their cause to help track how widespread the problem is. Finally, they want their daughter back, who went from an active life on the soccer field and playground, to a life in the dark.

"It seems like such a small, simple request. Put a label on the bottle on the box."

"Right, and also make people aware, make them understand what SJS is."

"Why wouldn't a drug company just do that?"

"I assume they're worried about losing business, but better to lose business than children's lives. Children's lives, I can't believe they're willing to do that."

A spokesperson for Children's Motrin would not answer our questions, but did provide us with this statement: "We are aware of a report of a seven-year-old girl diagnosed with SJS allegedly associated with the use of Children's Motrin. SJS is a very rare condition. While specific causes of the condition in any given instance are unknown, it has been reported to be associated with a wide variety of medications and may also be caused by a viral infection." She went on to say they are investigating Sabrina's case.

Earlier this year, Sabrina testified in front of the FDA in Washington herself, asking that Johnson & Johnson include warning labels about SJS on Children's Motrin. This case could go to court in a year or two.

Almost any drug can cause SJS. Even a drug you've taken safely before. And anyone can get SJS, not just children. Here are the signs you need to watch for:

Stevens Johnson Syndrome often starts with a rash, but not always.

The rash turns to blisters.

The skin around the eyes and mouth look cracked and swollen.]]> Family Sues J&J Unit Over Drug Reaction http://www.yourlawyer.com/articles/read/9478 Tue, 15 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9478
Simon Saw began to develop internal and external blisters after his father gave him the Children's Motrin, which is an over-the-counter liquid ibuprofen, according to the lawsuit filed yesterday in U.S. District Court in Newark.

Kathy Fallon, a spokeswoman for McNeil Consumer & Specialty Pharmaceuticals, a subsidiary of New Brunswick-based Johnson & Johnson, said she could not comment on the specifics of the lawsuit because she had not seen it.

"Obviously, we're concerned about all matters related to our product," she said.

Saw remained hospitalized at Texas Children's Hospital for about 23 days last March for the severe blistering. He was re-admitted to the hospital in April with respiratory distress.

Lawyers for Saw allege the Stevens-Johnson Syndrome was caused by the Children's Motrin. As a result of the drug reaction, the boy required a lung transplant surgery, eyelid surgery and suffered temporary paralysis, according to the lawsuit.

Johnson & Johnson, McNeil- PPC and Purepac Pharmaceutical, which is part of Alpharma, are all being sued by the boy's parents, Chiu Pin Saw and Lin Chu Saw of Needville.

In December, lawyers for a 7-year-old California girl sued Johnson & Johnson, alleging Children's Motrin caused her to suffer from Stevens-Johnson Syndrome. The girl, Sabrina Brierton Johnson, became blind from the reaction she suffered after taking the medicine, according to her lawsuit.

The cause of Stevens-Johnson remains uncertain, although it is believed to result from certain antibiotics or from a viral infection, Fallon said.

Stevens-Johnson Syndrome is not listed among the possible dangers associated with over-the-counter Children's Motrin, although it was included among the risks when it was sold as a prescription medicine.]]> Lawsuits Prompt Closer Look At Rare Disease Linked To Ibuprofen http://www.yourlawyer.com/articles/read/9146 Mon, 03 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9146
All three girls developed a rare, excruciatingly painful disease after an apparent allergic reaction to ibuprofen. and the parents of all three said they never dreamed that an over-the-counter pain reliever sold everywhere from supermarkets to the corner 7-Eleven could kill or disable their children.

The U.S. Food and Drug Administration has not required the makers of ibuprofen to include the life-threatening disease or its symptoms on non-prescription labels, even though warnings are required on prescription-strength ibuprofen and other prescription drugs that can cause the same reactions. The FDA and a spokesman for the maker of Children's Advil told the San Jose Mercury News that no warning is needed because the disease is so rare.


But after the third lawsuit in two years was filed last week against the makers of Children's Motrin health care giant Johnson & Johnson and its subsidiary, McNeil Consumer & Specialty Pharmaceuticals a spokeswoman said McNeil will look into the case.

"As the makers of Children's Motrin products, we are deeply concerned by all matters relating to our products and we are investigating the situation," said Bonnie Jacobs, spokeswoman for the Fort Washington, Penn.-based McNeil.

Fran Sullivan, spokesman for Wyeth Consumer Health Care, the maker of Children's Advil, told the Mercury News he had no personal knowledge of Heather Rose's death, but added: "If it turns out this child died after taking Children's Advil, we would look into it as well. We want to get the information so we can investigate it."

In the suit filed last Tuesday, Brierton Johnson and her parents allege that Motrin's makers knew the product could cause the rare and sometimes deadly allergic reactions called Stevens Johnson Syndrome and toxic epidermal necrolysis and that they failed to warn consumers.

The family is seeking monetary damages, but also wants the drug maker to take Children's Motrin off the market until it carries a warning about the syndrome and its symptoms. They said parents and doctors need to know that they should stop giving children ibuprofen at the first sign of a rash to prevent the disease from advancing to the more serious toxic epidermal necrolysis, which has about a 30 percent mortality rate. Symptoms also include blisters on the ears, nose and genital area and sores on the inside of the mouth.

Kaitlyn's parents received a confidential settlement in a similar suit in November and said they can no longer discuss the case. McNeil also settled in November with the parents of a young Texas girl.

Prior to the settlement, Kerry Langstaff, Kaitlyn's mother, said the family hoped to educate the medical community and parents about this over-the-counter drug causing this disease.

"We can't tell you how many doctors and nurses have said to us, 'I didn't know.' " Langstaff said.

After a 20-month struggle to overcome the disease, which left her unable to see, speak, breathe on her own or eat without a tube in her stomach, Kaitlyn died just before Christmas a year ago.

Dr. Roy Levin, who said he was unaware of the association between Children's Motrin and Stevens Johnson Syndrome until he treated Kaitlyn Langstaff, said of the drug companies: "They have to warn people who think it's as safe as getting M&Ms."

And Darlene Kiss, Heather's mother, said she believes parents have the right to know that medicines used routinely for children have the potential for such catastrophic consequences.

"Even if it's a verbal warning from the doctor, it would make you think," said Kiss, who named her baby daughter Heidi Rose in honor of Heather Rose, who died March 17, 2003. Kiss has hired an attorney but has not filed suit.

A number of other drugs can cause Stevens Johnson Syndrome, and some of them - including prescription-strength ibuprofen - carry warnings about the risk of the severe skin reactions. Though the FDA has acknowledged that ibuprofen can cause the syndrome, the government has not ordered pharmaceutical companies to mention the disease that killed Heather Rose and Kaitlyn on over-the-counter ibuprofen labeling, saying the risk of harm is too low.

Space on drug labels should be devoted to more common adverse reactions, such as gastrointestinal bleeding and kidney problems, the agency says.

"There is only so much you can put on a label," the FDA said in a statement to the Mercury News. "We already know that the longer the labels, the less someone is going to read them."

There are an estimated one to six cases of Stevens Johnson Syndrome per million people in the United States each year, due to drug reactions as well as other causes. The FDA told the Mercury News it has received about 150 reports of the syndrome in patients who had used ibuprofen over the years. The agency would not say how common a side effect needs to be to trigger a specific warning on the label.

However, Pfizer announced last month that it will add a "black-box" warning - the strongest a drug can carry to the label of its prescription painkiller Bextra after 87 people taking the drug developed severe skin reactions, including Stevens Johnson Syndrome and toxic epidermal necrolysis, and four died. Bextra is part of the same broad class of drugs known as non-steroidal anti-inflammatory drugs or NSAIDs as ibuprofen.

The FDA has been under fire for months over its handling of safety concerns about other drugs, including Vioxx, a top-selling prescription NSAID used to treat arthritis pain. Vioxx was removed from shelves around the world in September after it was linked to an increased risk for heart attacks.

An FDA advisory committee in February will consider risks of Vioxx, Bextra and other NSAIDs "to determine whether additional regulatory action is needed," the agency said in Dec. 23 statement. It was not known whether the committee would address ibuprofen or Stevens Johnson Syndrome.

Stevens Johnson Syndrome and its various forms can afflict people of all ages. But the Stevens Johnson Syndrome Foundation has seen a jump in the number of cases involving children and ibuprofen reported to it in the past year.

"We're getting about one or two reports of new cases each month," said Jean McCawley, director and founder of the Westminster, Colo.-based foundation. "The only thing that's rare about SJS is that it's not mandatory to report it to the FDA."

These days Sabrina is back at home, but her eyes are so sensitive to light that she must wear a hat pulled down over her face all the time, and she has numerous other medical problems from the disease.

"Johnson & Johnson's failure to warn has cost Sabrina her sight and has cost other innocent children their lives," said her mother. "It's time for the truth to be told, and it's time for Johnson & Johnson to do the responsible thing and put proper warnings and instructions on Children's Motrin."]]> Lawsuit Claims Children's Motrin Causes Severe Side-Effects http://www.yourlawyer.com/articles/read/9129 Sun, 28 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9129
The lawsuit, filed on behalf of Sabrina Brierton Johnson of Los Angeles, seeks unspecified compensatory and punitive damages against health care giant Johnson & Johnson, subsidiary McNeil Consumer & Specialty Pharmaceuticals, and several other firms, including retailers Ralphs Grocery and Albertsons Inc.'s Sav-On pharmacies.

Kenneth and Joan Brierton Johnson accuse the defendants of negligence, breach of warranty and of concealing from consumers and doctors potential health risks of taking the flu and pain medication, specifically the risk of developing two disorders Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis which are typically caused by an adverse reaction to a drug or virus.

Sabrina took Children's Motrin drops Sept. 8, 2003, after she came home from school with a fever. The girl had no known drug allergies, according to the suit filed in Los Angeles County Superior Court.

The next morning, she woke up with a high fever and other symptoms, including a pink coloration in her eyes and sores in her mouth. She was hospitalized; a day later she was blind in both eyes.

Doctors later concluded Sabrina had contracted Stevens-Johnson Syndrome from taking Children's Motrin, according to the lawsuit. Since then, she has had multiple eye surgeries.

"In the name of children everywhere, our family wants Children's Motrin taken off the market until it carries a warning label about the risk of Stevens-Johnson Syndrome and describes its symptoms," the girl's mother said in a statement.

Bonnie Jacobs, a spokeswoman for Fort Washington, Pa.-based McNeil, which manufactures Children's Motrin, said McNeil and Johnson & Johnson were aware of a report that a 7-year-old girl allegedly developed Stevens-Johnson Syndrome after taking the medication.

"As the makers of Children's Motrin products, we are deeply concerned by all matters relating to our products and we are investigating the situation," Jacobs said.

She declined to discuss the case further.

Representatives of Sav-On and pharmaceutical distributor McKesson Corp., also a defendant, declined to comment. Messages left with Dublin, Ohio-based Cardinal Health and Kroger Co.'s Ralphs chain were not immediately returned.]]> Children's Motrin Stevens-Johnson Syndrome Side Effects Attorney http://www.yourlawyer.com/topics/overview/motrin Sun, 28 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/motrin DOWNLOAD OUR MOTRIN INFORMATION PACKAGE

Injured by Motrin?

The family of 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 can lead to blindness. SJS causes 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. Jean McCawley, founder of Stevens-Johnson Foundation, whose daughter also suffers from the condition, said cases are typically under-reported to the Food and Drug Administration because the reporting system for adverse drug reactions is voluntary, not mandatory.

"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 many other prescription and over the counter painkillers. Stevens Johnson Syndrome is associated with several drugs including Bactrim, Bextra and other drugs.

If you or a loved one took Motrin and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>