Yourlawyer.com (Stevens Johnson Syndrome News)

Intelence Linked to Stevens-Johnson Syndrome, Other Serious Skin Reactions

Thu, 27 Aug 2009 00:00:00 -0700

Intelence (etravirine), an HIV medication made by Johnson & Johnson's Tibotec division, has been associated with serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. The company recently sent a letter to health care providers informing them that the prescribing information for Intelence would be updated to include information about systemic hypersensitivity reactions, sometimes accompanied by liver failure, that have occurred in some users.

Intelence was approved by the Food & Drug Administration (FDA) in 2008. It is a non-nucleoside reverse transcriptase inhibitor, and is used to treat people who have become resistant to other HIV medications.

According to Bloomberg.com, toxic epidermal necrolysis has killed one patient and injured another since Intelence was approved in January 2008. Another patient reported a hypersensitivity reaction accompanied by liver failure. According to Tibotec, in clinical trails 1.3 percent of people taking Intelence developed moderate to severe rashes, compared with 0.2 percent of people who received a placebo in those trials.

According to the letter from Tibotec, the existing Warning and Precaution regarding Severe Skin Reactions has been strengthened to reflect these reports. Additionally, guidance has been added that Intelence should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.

According to the letter, the hypersensitivity reactions associated with Intelence are characterized by rash, flulike symptoms and sometimes organ problems, including liver failure. Rashes typically appeared within the first six weeks of therapy with Intelence. If the rash becomes severe, the prescribing information warns, individuals using the drug should contact their health care providers immediately to discuss possibly stopping Intelence.

Stevens-Johnson syndrome is a hypersensitivity complex affecting the skin and the mucous membrane. The disorder causes blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. Toxic epidermal necrolysis presents with a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body. Both disorders can be life threatening.

Revlimid Linked to Steven-Johnson Syndrome, Toxic Epidermal Necrolysis

Fri, 19 Sep 2008 00:00:00 -0700

Revlimid, a blood cancer drug made by Celgene Corp., has been associated with Stevens-Johnson Syndrome and toxic epidermal necrolysis, serious and potentially fatal skin disorders. A spokesperson for Celgene told The Wall Street Journal that it is likely the label for Revlimid would be updated in the future to include reports of the skin reactions.

Revlimid was the first of Celgene's new class of oral cancer drugs called IMiDs (immunomodulatory drug). IMiDs modify or regulate the functioning of the immune system. Revlimid was approved in December 2005 to treat a bone-marrow disorder known as myelodysplastic syndromes and later approved for multiple myeloma, a type of blood cancer.

According to a newsletter posted on the Food & Drug Administration (FDA) website, the agency has received 14 reports of Stevens-Johnson syndrome or toxic epidermal necrolysis through January 2008. The agency said it received three reports of deaths in patients with the skin conditions, though in one case the cause of death was listed as the progression of a type of blood cancer.

The agency said eight of the patients had reported either taking or previously being on other drugs that could have also caused the skin reactions. However, the FDA said in at least two cases it appeared that Revlimid played a role in the development of skin reactions.

Stevens-Johnson Syndrome is a hypersensitivity complex affecting the skin and the mucous membrane. The disorder causes blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. Toxic epidermal necrolysis presents with a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body. Both disorders can be life threatening.

Information about Stevens-Johnson Syndrome and Toxic epidermal necrolysis is currently not included on the Revlimid label. The FDA said doctors need to be aware of the possibility that Revlimid could cause serious skin reactions, and said the drug should be discontinued if a skin rash appears.

Family of Girl Blinded by Stevens-Johnson Syndrome Sues Maker of Children's Motrin

Mon, 16 Jun 2008 00:00:00 -0700

The family of a young girl blinded as a result of Stevens-Johnson Syndrome blames Children's Motrin for her injuries, and has taken the maker of the over-the-counter pain reliever to court. The family's lawsuit is seeking better labeling for the pain reliever, as well as compensatory and punitive damages from McNeil PPC, and its parent, Johnson & Johnson.

Stevens-Johnson Syndrome is a sometimes life-threatening hypersensitivity complex affecting the skin and the mucous membrane that may be caused by many drugs, viral infections, and malignancies. Steven-Johnson Syndrome is characterized by blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. It can cause the top layer of the skin to separate from the lower layer of the skin in affected areas. Stevens-Johnson Syndrome is fatal in about 5 percent of all cases.

Because it involves the mucus membrane, Stevens-Johnson Syndrome usually requires treatment in a hospital burn unit. A recent New York study linked ibuprofen to nearly half of the 32 children referred to a local burn unit over an eight-year period.

The parents of Sabrina Johnson, who was six at the time of her diagnosis, said she was given two doses - one in the afternoon and another later in the evening - of Children's Motrin one day in 2003 to alleviate symptoms of a fever. According to the lawsuit, Sabrina awoke the next morning with a high fever, her eyes were pink, and her mouth was swollen and covered in sores. Sabrina was immediately hospitalized, but by the next day, she was blind in both eyes. Doctors then diagnosed Stevens-Johnson Syndrome.

Sabrina's lawyer alleges that Johnson & Johnson knew of a link between ibuprofen, the active ingredient in Motrin, and Stevens-Johnson Syndrome. The lawsuit points out that while the prescription version of the drug has stronger warnings, the over-the-counter version mentions nothing about this risk.

Jury selection for Sabrina's lawsuit, which is being heard in Los Angeles Superior Court, began last week. Arguments are expected to begin this week. Sabrina's Stevens-Johnson Syndrome lawsuit is the first of nine similar lawsuits scheduled to begin this year and next in the US.

Carbamazepine Gets Warning on Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis

Wed, 12 Dec 2007 00:00:00 -0800

Carbamazepine, a drug used to treat epilepsy and bipolar disorder, will now come with new warnings that Asian patients should undergo genetic testing before using the drug. According to the Food & Drug Administration (FDA), a human leukocyte antigen called HLA-B*1502 that is exclusive to people with Asian ancestry makes it more likely that carbamazepine will cause the serious skin disorders Stevens-Johnson Syndrome and toxic epidermal necrolysis.

Carbamazepine is an anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy and bipolar disorder. It is also used to treat other disorders, including Attention Deficit Hyperactivity Disorder and schizophrenia. It is sold under the brand names Carbatrol, Equetro and Tegretol.

According to the FDA, the HLA-B*1502 leukocyte puts carbamazepine patients at a higher risk of developing Stevens- Johnson Syndrome and toxic epidermal necrolysis. Stevens-Johnson Syndrome is a hypersensitivity complex affecting the skin and the mucous membrane. The disorder causes blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. Toxic epidermal necrolysis presents with a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body. Both disorders can be life threatening.

The FDA says that the HLA-B* 1502 leukocyte occurs in varying frequency in persons of Asian decent. Roughly 15% or more of patients may carry the leukocyte in parts of China, Thailand, Malaysia, Indonesia, the Philippines, and Taiwan. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2 to 4%, but higher in some groups. HLA-B*1502 appears to be present at a low frequency, (less than 1%) in Japan and Korea. However, as the freqiemcu of HLA-B*1502 in Asia has not been subjected to a great deal of study, the FDA says that doctors should only use these statistics as a guideline when considering the use of carbamazepine. A simple genetic blood test is the only way to determine if a patient carries this leukocyte.

The new carbamazepine warning, carried in the label’s boxed warnings section, advises physicians to have patients of Asian decent undergo the blood test. Those who test positive for HLA-B*1502 should not be prescribed carbamazepine. The warning also cautions that such patients might also be at risk from Stevens-Johnson Syndrome and toxic epidermal necrolysis from other drugs for which these disorders are a potential side effect. Tested patients who are found to be negative for HLA-B*1502 have a low risk of Stevens-Johnson Syndrome and toxic epidermal necrolysis from carbamazepine, but these disorders can still rarely occur, so healthcare professionals should watch for symptoms in these patients.

The FDA also says that 90% of Stevens-Johnson Syndrome and toxic epidermal necrolysis occurs within the first few months of treatment with carbamazepine. Thus, patients of any ethnicity or genotype (including HLA-B*1502 positive) who have been taking carbamazepine for more than a few months are at low risk of developing Stevens-Johnson Syndrome and toxic epidermal necrolysis.

Stevens-Johnson Syndrome Affects Mother and Son Taking Nevirapine

Fri, 03 Jun 2005 00:00:00 -0700

Two cases of the rare side-effect of nevirapine, Stevens-Johnson syndrome, involving a mother and her son, are reported in the June 10th edition of AIDS. The investigators "are unaware of any previous familial clustering" of Stevens-Johnson syndrome associated with nevirapine treatment.

The non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine is a standard component in first-line HAART regimens used in resource-limited settings. It is likely to remain widely used once lower-cost, fixed dose, generic antiretroviral therapy becomes more widely available, and it is anticipated that 100,000s of individuals will initiate antiretroviral therapy with nevirapine.

Rash and hepatological toxicities are well documented side-effects of nevirapine therapy, and to minimise the risk of hepatotoxitity it is recommended that women do not initiate treatment with nevirapine if their CD4 cell count is above 250 cells/mm3 and men if their CD4 cell count is above 400 cells/mm3.

Although rash in the early weeks of nevirapine therapy does not necessarily lead to the discontinuation of treatment. Stevens-Johnson syndrome is a rare, but potentially life-threatening necrosis of the skin and can occur in patients taking nevirapine across CD4 cell counts.

Investigators from Uganda reported two cases of Stevens-Johnson syndrome that occurred in a mother and her eight-year- old son who both took nevirapine in combination with d4T and 3TC.

The mother was 31 years old and nave to antiretrovirals when she started therapy in March 2004. At this time her CD4 cell count was 195 cells/mm3. On the fourteenth day of therapy, whilst still taking the once-daily 200mg induction dose of nevirapine, she was admitted to hospital with a five day history of generalised rash and skin ulceration. She was diagnosed with Stevens-Johnson syndrome and treated with steroids, fluids and antimicrobials. She recovered and was discharged from hospital a month later. Kaletra replaced nevirapine in her HAART regimen.

In May 2004, her eight-year-old son started treatment with d4T, 3TC and nevirapine. His baseline CD4 cell count was 279 cells/mm3 and he had been diagnosed with AIDS.

Nevirapine was dosed at 4mg per kg once a day for the first 14 days, and then 4mg per kg twice a day. On day 28 of antiretroviral therapy the boy was admitted to hospital with a two day history of ulcerative rash. Treatment with intravenous fluids, steroids and antimicrobials was provided, to which the boy initially responded. However, on day 25 of hospitalisation, he developed a fever, restlessness, altered mental state, and, probably because of sepsis, died.

The investigators speculate that genetic factors may have increased risk of Stevens-Johnson syndrome in these individuals. They note, however, that "no specific guidelines exist regarding the use of nevirapine in first-degree relatives of individuals who have experienced nevirapine-associated adverse reactions."

Large numbers of HIV-positive children will require therapy with nevirapine in resource-limited setting, note the investigators. Because of this, the investigators caution "the scenario we report here will become more common as ART expansion continuesadditional research is needed to investigate the degree to which serious nevirapine toxicities can be predicted on the basis of genetic factors or previous toxicity in first-degree relatives."

Family Sues J&J Unit Over Drug Reaction

Tue, 15 Mar 2005 00:00:00 -0800

A subsidiary of Johnson & Johnson is being sued by the parents of a 6-year-old Texas boy who suffered a severe reaction known as Stevens-Johnson Syndrome after being treated with Children's Motrin.

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

Mon, 03 Jan 2005 00:00:00 -0800

Nine-year-old Kaitlyn Langstaff of Saratoga died 20 months after taking Children's Motrin. Sabrina Brierton Johnson of Los Angeles went blind two months after the 7-year-old took the same drug. Three-year-old Heather Rose Kiss of New Jersey died a week after taking a few doses of Children's Advil.

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."

Rising Prescription Drug Use Corresponds to Increase in Stevens Johnson Syndrome

Mon, 13 Dec 2004 00:00:00 -0800

With more than 40 percent of Americans taking at least one prescription drug (2004 CDC report), the potential for the deadly adverse drug reaction known as Stevens Johnson Syndrome (SJS) is increasing.

Described in many drug warning inserts as a "serious skin condition," SJS is actually a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases.

An under-reported and under-recognized condition, people develop SJS from commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such as adult and children ibuprofen products. Because many physicians and emergency facilities are not familiar with the symptoms, treatment is frequently delayed, further exacerbating the condition.

To recognize SJS in its earliest stage, the SJS foundation urges patients and physicians to watch for the following symptoms when taking medications:

Persistent fever

Burning or blistering of the mucous membranes, i.e.: eyes, ears, mouth, nose, genital area.

Rash, blisters or red splotches on skin
Flu-like symptoms
History of a reaction to prescribed drugs or over-the-counter medications.

In one estimate, SJS is reported to effect three to eight people per million per year in the U.S. However, the frequency could be much higher since only one percent of adverse drug reactions is reported, according to the Food and Drug Administration.

"SJS is not as rare as we are led to believe," said Jean McCawley, president of the SJS Foundation. "As prescription drug use increases, we are being contacted by increasing numbers of people. During the winter months, we learn of 15 new cases a week, and that's only people with Internet access."

Her Body Burned By Drug, Not Fire

Tue, 04 May 2004 00:00:00 -0700

A beautiful 18-year-old Tucson softball player has suffered severe burns over 80 percent of her body but has been nowhere near a fire.

In an extremely rare, often fatal and little known severe toxic reaction to a medical drug, Samantha Grasham's body caught fire from the inside out blistering most of her skin, as well as her mouth, throat, esophagus and airway, perhaps leaving her scarred for life.

She spent nearly three weeks in the Burn Unit at St. Mary's Hospital, as doctors there worked to save her life and her skin.

As happens in most of these strange cases of what is known as Stevens-Johnson syndrome, there was no warning that Grasham would react so severely to a medication.

Most people never know they are at risk, and doctors often do not recognize the syndrome when they see it. Yet many common drugs including prescription painkillers and antibiotics even over-the-counter pain and fever medicines for children are linked to this "fire in the flesh."

In the worst cases, people are not only scarred, but also blinded and dependent on breathing and feeding tubes if they survive. In its severe form, when the skin is literally burned off the body and even internal organs are damaged, about half die.

The U.S. Food & Drug Administration has issued dozens of warnings about drugs that can trigger Stevens-Johnson syndrome (SJS) including the one given to Grasham but the warnings receive little publicity.

"I think it is commonly misdiagnosed, especially in the early stages," said Dr. Norman Levine, longtime University of Arizona dermatologist, who sees about one case a year.

"But a physician will seldom miss it in a very sick patient, once it has severely progressed. When that happens, it can be devastating."

Although the syndrome is rare occurring at the rate of about 1 to 7 cases per million people per year some say it is starting to increase significantly as more antibiotics and anti-inflammatory drugs hit the market.

"The problem is that the drugs causing this syndrome are unbelievably common things like ibuprofen, that people take every day," said Levine. "Something in the drug leads to a very inappropriate, wildly inflammatory immune response that causes the skin to die.

"It's completely unpredictable. Someone can be taking a drug safely for years, then all of a sudden have a horrible reaction to it. Those who get it are not highly allergic. This is just plain bad luck."

In the case of Samantha Grasham, the syndrome stopped her life cold, ending her athletic scholarship, her education, her life plans.

"I was always so active and involved - in sport and games. I loved college, and traveling," she said. "Now there is nothing - just these scars all over my body." Like many victims, she now battles chronic fatigue.

The former softball star at Desert View High School entered El Paso Community College in Texas last fall on a two-year athletic scholarship.

But in early January, during the first day of softball practice, she had an unexpected, one-time seizure that caused her to fall and black out.

After a series of tests back home in Tucson, Grasham was placed on an anti-seizure drug, Lamictal, by a neurologist, who told her she could return to school and go on with her life normally.

She did, but about 10 days after starting the drug, she noticed a small rash on her arm. Though she played first base in a softball game the next day, the rash by then had spread to her arms, legs, back and face.

With the rash worsening by the hour, now itching and burning, her ears and mouth starting to blister, Grasham went to urgent care in El Paso. A doctor there correctly diagnosed an allergic reaction to the drug she was taking but never told her to stop taking it the first terrible mistake. After getting an allergy medicine, she was sent home.

Two days later, "my face was on fire," as Grasham describes it, and the burns were moving down her airway, interfering with her breathing. She went back to urgent care, where again no one told her to stop the drug. Instead they gave her another drug, prednisone, also linked to cases of Stevens-Johnson syndrome.

The next day, her whole body now blistering and burning, her face completely inflamed, Grasham's family made an emergency trip to El Paso.

"Oh my God, I couldn't even speak when I saw her. I couldn't even cry I was so shocked," said her mother, Patricia Grasham. "Her mouth was one big blister; her face was all red and swollen. Her eyes were burning so bad we had to keep wet towels on them all the way home. The blisters were all over her mouth and down her throat. She was drooling, and in so much pain."

Driving straight to the emergency room at Tucson Medical Center, the family finally found out what had attacked their daughter. An emergency physician immediately diagnosed Stevens-Johnson syndrome and nailed Lamictal as the likely cause.

Grasham remembers many doctors and nurses coming into her room to see this highly unusual and bizarre eruption, many of them for the first time.

"Once you see the mucous membranes blistering, and you get a history of how this progressed in the patient, an emergency physician should know what they're looking at," said Dr. Ron Widman, chief of emergency services at TMC.

"But this is not very common, so yes, certainly, we want our young doctors to see it."

Although Grasham was finally off Lamictal, the syndrome kept worsening - possibly fueled by adding prednisone to the other drug. She was struggling to breathe as the burns marched down her respiratory tract.

Two days later, on March 5, with the severity of her burns reaching second degree, Grasham had to be moved to St. Mary's burn unit.

SJS patients who reach this stage of damage when more than 35 percent of the body is blistered or burned are diagnosed with toxic epidermal necrolysis, or TENS. At that point, the mortality rate is around 50 percent.

But after 18 days of intensive treatment - including extremely painful debriding of her burned skin, bandaging, infection control and special nursing care, Grasham finally left St. Mary's, alive but scarred. She has continued daily treatment as an outpatient.

"If only they had known what they were looking at in (El Paso) urgent care, I don't think this would have gotten so bad," her mother said.

But many doctors will never see a case of Stevens-Johnson syndrome, said Dr. Jeffrey Nelson, a plastic surgeon and burn specialist at St. Mary's burn unit.

Nelson, obviously familiar with it in his specialty has treated about 10 to 12 cases during his nine years at St. Mary's, with antibiotics and anti-convulsants the most common trigger.

"It feels like I've seen a lot more cases in the last three years than in the three years before that, but I have no way of knowing if that is an accurate trend," he said. SJS is not a reportable disease.

But warnings about the SJS-drug link have been emerging more frequently in recent years. In 1997, the Food and Drug Administration posted a warning on the drug Grasham took, Lamictal, and the drug's maker, Glaxo Wellcome, added a boxed, boldface warning to the drug's label saying the drug has caused "severe, potentially life-threatening rash, including Stevens-Johnson syndrome and, rarely, toxic epidermal necrolysis."

The warning notes that the reaction is occurring in about one of every 1,000 adults taking the drug, but at dramatically higher rates in children - as high as one in 50.

"Lamictal is not approved for use in patients below the age of 16," the label now reads.

Today, with no scholarship, her dreams of higher educations shot, she is at a loss over her future.

"I just don't know. I need to find a job," she said softly. "This is such a nightmare."

Lawsuit Claims Children's Motrin Causes Severe Side-Effects

Sun, 28 Dec 2003 00:00:00 -0800

The parents of a 7-year-old girl Tuesday sued the makers of Children's Motrin and several other companies that distribute it, claiming their daughter lost her eyesight and suffered other severe side effects after taking the medication.

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.

Without Warning

Thu, 10 Apr 2003 00:00:00 -0700

A rare but debilitating and potentially deadly allergic reaction to some drugs, may be on the rise. But you won't read about it on drug labels.

KAITLYN LANGSTAFF'S catastrophic injuries are the stuff of nightmares. In 12 months, this 9-year-old girl from Saratoga has gone from being active and healthy to wheelchair-bound, blind and unable to eat or speak. With massive scarring in her lungs and airways, she breathes bottled oxygen through a tube inserted in her neck. She relies on a feeding tube in her stomach. She mouths words with the aid of an electronic larynx. She will need countless surgeries to reclaim what's left of her health.

Langstaff's story, her courage, the poems she's written (one of which was recorded as a rock song by the band Miggs) and her family's resilience has made national news. So has her incredible survival, against all odds, after she was diagnosed in April 2002 with toxic epidermal necrolysis, a relatively rare and often lethal form of Stevens-Johnson syndrome, a frightening blistering and burning disease brought on by a severe, systemic allergic reaction to certain drugs.

But what many people haven't heard are claims of an alarming rise in case reports of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), according to some observers. Support groups for the disease's survivors have popped up. Complaints to the FDA's MedWatch database are reportedly mounting, accompanied by a surge of lawsuits filed against doctors, hospitals and drug manufacturers.

The medications that most often provoke this extreme allergic reaction are widely used by both adults and children. They include antibiotics such as penicillin and bactrim; anti-convulsants such as phenobarbital and Dilantin; and prescription pain relievers called nonsteroidal anti-inflammatory drugs (NSAIDs)such as Bextra and Daypro. And perhaps even more worrisome, over-the-counter NSAIDs such as ibuprofen, including Children's Motrin and Children's Advil are also triggering the reaction.

Growing List

No accurate count exists of how may people have been stricken with TEN or SJS, or its milder version, erythema multiforme. Once a drug is approved, physicians are not legally required to report adverse reactions to the FDA. (Less than 1 percent of drug reactions are reported to the federal government.) Some estimate that there have been 200,000 SJS and TEN cases worldwide, but that's only a rough guess.

At least 50 percent of known SJS cases are drug related, experts say; other cases may have viral or bacterial origins. (TEN, however, is predominantly caused by drug reactions.) Children in particular seem to be more susceptible to SJS, and some say women are as well. SJS and TEN often cause blindness, and in 10 percent to 30 percent of cases, death. More than half of the patients who have TEN die.

While stressing that the reaction is rare, some of those who track SJS and TEN say the number of cases is climbing, although the evidence remains anecdotal. Jean McCawley of Denver, Colo., president and founder of the Stevens Johnson Syndrome Foundation, says her group now has 1,500 members. (Her daughter had SJS.) The website posts wrenching personal testimonials from people who have lived through the disease. McCawley says she has also seen a steady rise during the last two years of children getting SJS after using Children's Motrin, about one new case each month.

Paula Fillari, a veteran registered nurse with the Bothin Burn Center at St. Francis Memorial Hospital in San Francisco, which treats only the most dire cases of TEN--says the hospital now sees five patients a year, more than double the previous number of admissions. (Fillari presented a pilot study on new protocols for treatment of the disease at an international burn conference last year.)

"As more medications, antibiotics and anti-inflammatories get onto the market, there's potential for more medications causing this," Fillari says. "The list is getting longer."

But other experts caution that there is no evidence that more people are getting the allergic reaction. With no mechanism in place to monitor the incidence of the disease, it's just impossible to tell, says Dr. Bernard Cohen, director of pediatric dermatology at Johns Hopkins Children's Center in Baltimore, Md. The overall incidence is thought to be 1 to 6 per million patients, he notes.

"The bottom line is, any time you use a drug you can have an adverse reaction; you're always taking a risk," Cohen says. SJS and TEN are uncommon, he adds, "but when it happens, it can be devastating. With TEN, it's a disaster."

"I think it's a bigger problem than people realize," says Valerie Chereskin, a San Diego PR consultant who had SJS in 1990. "When you talk to someone, you quickly discover other people who've also had [SJS]; they just come out of the woodwork."

Both Chereskin and Cohen agree, however, that doctors are often unfamiliar with the disease, its symptoms and its debilitating effects, and can misdiagnose it. "When you get SJS, [many] doctors don't even recognize it," Chereskin says. "So they give you more of the drug that caused it--doing you more harm, which could end up killing you."

Like Swallowing Lye

This is precisely what Brad and Kerry Langstaff think happened to their daughter Kaitlyn. On April 6 of last year, while on a family trip, Kaitlyn, then 8 years old, was given Children's Motrin by her parents for fever and a sore throat. (She had no known drug allergies and was given the correct dosage.)

The next day, Kaitlyn broke out in a severe rash and high fever. She continued taking the drug every four to six hours when she was taken to Fresno's Children's Hospital, where she was diagnosed with TEN and admitted to the pediatric intensive-care unit. It wasn't until the third or fourth night in the PICU that a doctor at the hospital recommended that she stop taking the drug.

In the meantime, Kaitlyn rapidly developed blisters and lesions resembling second-degree burns throughout her body. With SJS and, especially, the more severe TEN, the immune system attacks the body inside and out--in particular, the skin and mucous membranes. Kaitlyn's skin sloughed off, and with all her nerve endings exposed, she was in excruciating pain. Blisters on the inside of her eyelids fused her eyes shut, and scarring on her corneas left her unable to see. Her tongue stuck to her palate and had to be surgically separated.

Filled with scar tissue, her lungs and airways closed down, forcing doctors to give her a permanent tracheostomy. She suffered severe kidney damage and loss of hearing. She endured multiple blood transfusions and operations to remove vast amounts of dead and damaged skin, among other treatments. She had to be heavily sedated and tied to her bed.

In all, Kaitlyn was hospitalized for 110 days at four different hospitals, and she was close to death several times. On April 15, she was airlifted to Los Angeles' Children's Hospital because it appeared she might need a heart-lung machine. On May 28 she was transferred to Lucile Salter Packard Children's Hospital at Stanford for more treatment, later to be moved to the Santa Clara Valley Medical Center. Kaitlyn will have to wait years before surgery is attempted to open her airways or to try corneal transplants to have her vision restored.

Kaitlyn's mother, Kerry Langstaff, has said that doctors likened the condition of Kaitlyn's throat to a patient who has swallowed lye, and her lungs to someone who has cystic fibrosis. (Because they were accompanying Kaitlyn, who was receiving a medical procedure last week, Kerry and Brad Langstaff were unavailable for comment.)

Another parent describes a similar set of circumstances. Melanie Eden's 7-year-old son, Sam, also got SJS last year after taking Children's Motrin. "In my gut, I feel like it was the Children's Motrin, but no one can prove that," says Eden, who lives near Phoenix, Ariz. Five days after he was given the drug for a cold, Sam couldn't go to the bathroom or swallow, and he had bright red eyes and blisters on his tongue. The doctors at the hospital misdiagnosed his symptoms, which got worse. But doctors at another hospital quickly realized that he had SJS and put him in the ICU for 10 days, the entire time on morphine.

"I was in shock," Eden says. "I couldn't leave his side. I kept my hands on him; I felt if I could touch him, he wouldn't go away." Because of the burning and blistering, Sam now has asthma; his eyes won't tear; and his nose is painfully dry.

"It breaks my heart, but he can see; many kids come away blind," she says. "There's a reason why hospitals give children Tylenol," she adds. "It doesn't react with the body's systems the way NSAIDs do. People need to know what the risks are."

Jean McCawley's daughter. Julie, then only 11 months old, reacted violently after she was given both phenobarbital and Children's Motrin.

"There, right in front of my eyes, I watched the blisters erupting," McCawley says. The doctors thought the infant had chickenpox; it was only later that she was correctly diagnosed with SJS. "She looked liked she was deep-fried. I was terrified," McCawley recalls. Julie is now blind and has scarring in her nose, mouth, esophagus and lungs. "No amount of money will be enough to compensate for what this child has suffered," McCawley says from a hotel room in Boston, where Julie was undergoing a medical procedure to help restore her eyesight. (McCawley sued her doctor and lost.)

But it's not just children who have been diagnosed with the disease after taking medication. Valerie Chereskin was 35 when she was given Septra, a sulfa-based antibiotic, which precipitated her severe case of SJS in 1990.

"I looked like I was from another planet. I was in agony," she says. Her skin melted away; a minister was called in to perform last rites. She has since recovered. However, it was two years until she could go out in the sun, and now has an artificial tear duct to regulate moisture in her eyes. "People take drugs without even thinking about it, but drugs are not candy; they contain strong chemicals," she says. (She also sued her doctor, unsuccessfully.)

Marlene Kerber, a 48-year-old Los Angeles resident, contracted a severe case of TEN in 2000 after she was prescribed an anti-convulsant medication. She was in a drug-induced coma for 2 1/2 months and was burned over her entire body. "I had none of my own skin left," she says. Kerber regained her sight after numerous surgeries. "I count my blessings every day, believe me," she says. She sued her doctor for medical malpractice and won.

Rash Decisions

On March 12, 2003, Kaitlyn's parents sued the manufacturer of Children's Motrin: McNeil Consumer & Specialty Pharmaceuticals (a subsidiary of Johnson & Johnson). The suit, filed in U.S. District Court in San Jose, claims that the drug caused Kaitlyn's extreme allergic reaction. The suit alleges that the company failed to adequately test the drug for over-the-counter use with children and did not fully report its clinical trials on the drug. (Ibuprofen was approved for nonprescription use in children in 1996.)

Kaitlyn's parents also claim that the company failed to warn consumers in any of its materials or package inserts or on the drug box that the drug could cause SJS or TEN and, furthermore, what to do if a rash or mucosal lesions develop.

"We're aware of a report of a 9-year-old girl who was diagnosed with [TEN] allegedly associated with the use of Children's Motrin," says a company spokesperson. "As the manufacturer of Motrin/ibuprofen products, we're deeply concerned about all matters relating to our products and are investigating the incident."

"You have to be cautious about giving adult drugs to children," says James C. Barber, the Langstaffs' lead attorney, who is based in Dallas, Texas. "It wasn't until the last few years that drugs were even tested separately on children."

Barber adds, "The [drug's] warning says nothing about SJS and nothing about stopping and calling a doctor if a child develops a rash." (The drug's label does warn of severe allergic reactions including hives, facial swelling, asthma and shock, and advises that the drug be stopped and to consult a doctor if pain or fever gets worse, or if an allergic reaction or any new symptoms appear, among other signs.)

Barber's firm successfully sued Pharmacia and G.D. Searle, the manufacturers of Daypro, a prescription NSAID, on behalf of an adult woman who came down with a severe case of TEN after taking the drug. (The suit settled in 2002.) Barber is about to file two new suits on behalf of two children who contracted SJS, one after taking Children's Motrin and another after taking Children's Advil. (The anti-inflammatory Bextra now includes warnings about the risk of serious skin problems, including SJS, after a recent legal settlement.)

"If suing is going to make drug manufacturers more conscientious about warnings on drug labels, then that's good," says Lisamaria Martinez, a senior at UC-Berkeley who was blinded from a childhood bout of SJS. "It's really important to know what's in these drugs."

Dr. Cohen is skeptical that warnings about SJS will make a difference. "There's no test to predict who will get [SJS or TEN]," he says. "Even if a drug has a warning, with one in a million people getting [the illness], it won't stop people from using the medication."

Meanwhile, Kaitlyn battles on. "She is a brave, courageous little girl that represents everything good about the human spirit," says Mark Mills, legal assistant for Barber's firm. "She's an impressive child, and she has an impressive family. They have been devastated by this disease."

Bextra Celebrex Vioxx Stevens Johnson Syndrome Side Effects Lawyer

Thu, 10 Apr 2003 00:00:00 -0700

Stevens Johnson Syndrome (SJS)

Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are two forms of the skin disease that can cause rash, skin peeling, and sores on the mucous membranes. Stevens Johnson Syndrome is an immune-complex–mediated hypersensitivity disorder that may be caused by many drugs, viral infections, and malignancies. Often, the drugs causing the onset of Stevens Johnson Syndrome, such as Bextra, did not have warnings placed on their labels until recently. Patients unknowingly took these drugs and many developed the potentially fatal Stevens Johnson Syndrome.

In Stevens Johnson Syndrome, a person has blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. In toxic epidermal necrolysis, there is a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body. Both disorders can be life threatening.

Causes of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis are certain drugs in the following classes: non-steroidal anti-inflammatory drugs (both prescription and over the counter), sulfa antibiotics, antibiotics, barbiturates, anticonvulsants, anti-tuberculosis drugs, and the drug allopurinol. In rare cases SJS is caused by a bacterial infection.

If you or a loved one has taken either prescription or over the counter drugs and has been diagnosed with Stevens Johnson Syndrome (SJS), please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.