Side effects from famotidine are usually mild and include headache, dizziness, constipation, diarrhea and fussiness, however more serious effects such as hives, skin rashes and swelling have been reported. While reports of TEN associated with famotidine are rare, the condition can be life threatening.

SJS/TEN have been associated with as many as 2,000 medications, most often NSAIDs, antibiotics and anti-seizure drugs. SJS/TEN begins with a rash that blisters over causing the skin to slough off in sheets. Blisters can also form on the mucous membranes affecting the eyes, nose, mouth and genitals.

Famotidine is not a proton pump inhibitor (PPI) and thus was not among the heartburn drugs cited by a recent Food and Drug Administration (FDA) warning about the increased risk of wrist, hip and spine fractures with PPIs. Another heartburn medication, Reglan (metoclopramide), has also fallen under an FDA black box warning after reports of consumers who took the medication developed a serious movement disorder known as Tardive Dyskinesia.

SOURCE: Stevens Johnson Syndrome › Pepcid linked to serious skin reaction

SJS usually begins with a fever, sore throat and fatigue. As the condition progresses, purple spots begin to cover the face and trunk. Those spots fuse together into patches that eventually form blisters. The blistered area sheds off leaving the body exposed and causing extreme pain for sufferers. Ulcers and other lesions appear in the mucous membranes, usually the mouth and lips but also in the genital and anal regions. Lesions in the mouth can be extremely painful, which causes the patient to refuse food or water. Conjunctivitis in the eyes occurs in about a third of the population who suffer from SJS. The liver, kidneys and lungs can also be affected.

Mild cases of SJS – with less than 10 percent of body surface involved – have a mortality rate of about 5 percent. The more skin involved, the more life threatening it is. Those who survive often experience organ damage or failure, cornea scratching and blindness.

People who have suffered from SJS should wear a medical alert bracelet notifying others that they should avoid taking any drugs that carry a risk for the condition. Drugs that have been linked to SJS are required to include a warning of the risk of SJS on the medication’s safety packaging. Unfortunately, some people who have fallen ill with SJS believe they were not adequately warned of the potential side effects of the drugs.

SOURCE: Stevens Johnson Syndrome › Understanding causes of SJS can help reduce number of reactions

SJS is a serious condition. It is most identified by a rash on the skin. The rash can blister and peel away, giving victims the appearance of having fourth degree burns. Many are treated in burn units. Blisters can form on mucus membranes such as the eyes and throat making it difficult and painful for patients to eat, drink or void. Eye conditions and even blindness can occur. In more severe cases, SJS can cause seizures, coma and even death. In some cases, rashes and lesions may never appear, and often the condition goes undiagnosed until it is too late.

Several common prescription and over-the-counter medications have been linked to SJS, including ibuprofen, anti-seizure medicines and antibiotics. Not all drug labels provide current warnings about medical risks. For example, Motrin provided a warning of SJS on its label when the medication was only available by prescription. The over-the-counter Motrin product does not provide a warning on its label.

If you experience any symptoms of SJS, contact your doctor and ask to be taken off the medication. You may also want to consult with a product liability lawyer, as many are accepting legal cases to submit lawsuits against the makers of the drug companies for failing to adequately warn consumers of the risk for this serious adverse reactions to their medications.

SOURCE: Stevens Johnson Syndrome › Beasley Allen attorney warns public of serious adverse drug reactions

Common side effects of Tamiflu and Relenza include dizziness, vomiting and diarrhea. Other, more serious adverse reactions are rare but can occur, including Stevens Johnson Syndrome, or SJS. SJS is a rare reaction to medication that begins with rashes on the skin that blister over, causing the skin to peel off in sheets. Blisters also can form on the eyes and mouth, which can lead to ocular problems, dehydration, infection and, in severe cases, death.

In Hong Kong in particular, pharmacists are urging the public not to stock up on the antiviral medications, as they say the Chinese government has plenty of the medicines in stock to combat a pandemic should one arise. The urgings come just six years after the deadly SARS virus struck that nation. About 400 Chinese pharmacies – or 95 percent of the market – have joined a campaign to keep residents’ fears at bay. There have been no swine flu cases reported in Hong Kong to date.

“The pharmacies will advise individuals whether the symptoms they have reflect a cold or something more serious such as flu,” head of Pharmacovigilance Kevin Cheung Kin-man told The Standard. “If the symptoms persist for days, people will be advised to consult a doctor. In the meantime, in the case of colds, pharmacists will be able to recommend appropriate over-the- counter medication.”

SOURCE: Stevens Johnson Syndrome › Pharmacists warn against use of anti-virals amid swine flu scare

As a young child, Lisa contracted pneumonia and spent a month in the hospital. She grew up with an abusive stepmother and struggled through a difficult marriage. Despite the obstacles, she managed to raise two children and find a career in real estate. But last week, the young woman with an infectious personality, hit another road block. She was diagnosed with Stevens Johnson Syndrome (SJS), an adverse reaction to antibiotics prescribed to her following minor surgery.

SJS is a rare but life-threatening hypersensitivity disorder that presents with a rash on the skin. As the condition progresses, the rash blisters over and the skin begins to peel off in sheets. This causes great pain and makes the body prone to infection. Most patients are treated in burn units. The mucus membranes also can be affected, causing blisters to form in the mouth and on the eyes. Dehydration and ocular problems become serious side effects. Severe cases of SJS can be fatal.

More than 200 medications have been linked to SJS or its most severe form, toxic epidermal necrylosis (TEN), most commonly antibiotics, ibuprofen and anti-seizure medication. SJS and TEN doesn’t discriminate based on age or gender. The warnings on the medications’ label often go unnoticed. And the condition is so rare that it can be hard to diagnose.

Some organizations, such as the Stevens Johnson Syndrome Foundation seek to raise awareness and “provide information about adverse allergic drug reactions so a quick diagnosis can be made and the offending drug stopped as soon as possible.”

When Mark visited his sister Lisa, she was covered from head to toe with blisters and rashes. Despite her condition, she seems brave. “That’s why she’s my hero,” Mark says.

Mark Cripps is Managing Editor for the Dundas Star News, the Ontario, Canada newspaper where he shared the story of his sister.

SOURCE: Stevens Johnson Syndrome › Newspaper managing editor calls sister with SJS a hero

In 1996, McCawley’s then-11-month-old daughter Julie had a severe adverse reaction to seizure medication. Called Stevens Johnson Syndrome, or SJS, the condition is rare but life threatening. SJS presents with a rash on the skin that blisters over and peels away. Blisters also can form on mucus membranes such as the eyes and mouth, leading to dehydration, infection or vision problems. It caused McCawley’s young daughter to go blind.

McCawley had never heard of SJS but soon learned how more than 200 medications have been linked to SJS, such as anti-seizure medicines, ibuprofen and antibiotics. She set out to raise awareness of the condition so that other people wouldn’t suffer the way she and her daughter did.

In 1996, the Stevens Johnson Syndrome Foundation was launched. It serves as a community forum for those who have been touched by SJS and provides information on treatments and research to help those who suffer long-term side effects of SJS.

As the recipient of ABC 7’s Extreme Makeover contest, McCawley receives $5,000 and her foundation receives $5,000. McCawley says she will use the foundation money to print and distribute more fact sheets about SJS to hospitals throughout the country.

The money she receives personally has already been spent, she says. She used it to purchase a new insulin pump for her youngest daughter, Kerry, who has Brittle Type I diabetes and Celiac’s disease. It will also cover the family’s mounting medical expenses. Julie had three eye surgeries last year alone and McCawley’s husband suffers from rheumatoid arthritis and chronic obstructive pulmonary disease.

SOURCE: Stevens Johnson Syndrome › SJS Foundation founder wins Extreme Makeover contest

But last March, things went terribly wrong for Hannah. She noticed rashes developing all over her body. Those rashes began to blister and become painful. They also formed in her mouth and were so debilitating she couldn’t even speak. She had to write on a pad just to communicate. The rashes were accompanied by flu-like symptoms, and had become so severe in such a short time, she was taken to the emergency room. The doctors were baffled.

Hannah was admitted to the hospital while doctors monitored her worsening condition, giving her morphine for the pain. An eye doctor was called in to examine her eyes, which by now had begun to blister as well. That’s when Hannah first learned the name of her condition – Stevens Johnson Syndrome, or SJS.

SJS is a rare but life-threatening reaction to common medication in which the skin blisters over and begins peeling off in sheets. The eyes, mouth and other mucus membranes can blister over as well causing serious problems such as dehydration, infection and even death. Trileptal, which is also used to treat seizures, is one of several medications that can cause the serious reaction known as SJS. Other common medications linked to the condition include antibiotics and anti-inflammatory drugs such as ibuprofen.

Hannah spent three weeks in the hospital and gradually recovered. She attends high school, rides horses and enjoys the life of any 16-year-old. While she has overcome her battle with SJS, she still has lingering conditions to deal with. SJS has made focusing with her eyes difficult and painful. She recently got glasses to help with the condition. She also has to be careful what medications she takes because some medications may trigger SJS again. But she isn’t letting the problems keep her from doing “you know, normal high school teenager stuff.”

SOURCE: Stevens Johnson Syndrome › Hannah doing much better a year after battling SJS

I thought that comment was odd. But a week later, my sinus infection had not improved. I took the prescription to my pharmacist. I told him that my doctor had told me to only fill the prescription if I felt I really needed it. I asked if there was any reason I should not take the med, given that I simply was not getting over my ailment. The pharmacist nodded and said Ketek was a powerful antibiotic and had some strong side effects. But if a week had passed since seeing my doctor and I was not on the mend, perhaps I should fill it.

I’m not one to react adversely to medicine. And I can usually ride out minor side effects, believing that if it has been prescribed for me, it’s working some sort of miracle. I started the drug and almost immediately after taking the medication I felt even sicker than before, with dizziness, headaches and an overall feverish feeling. I took a second dose the next day and the miserable symptoms returned. I realized then that it must be the Ketek and stopped taking it.

You may remember me telling you about Kim Oakes. She’s the remarkable woman who survived a painful battle with toxic epidermal necrolysis (TEN), the most severe form of Stevens Johnson Syndrome (SJS). SJS/TEN is a severe adverse reaction to medication in which the skin blisters and peels away. The eyes, mouth and other mucus membranes can also blister over causing serious complications and even death.

More than 200 drugs have been linked to SJS/TEN. Kim’s reaction was caused by a common antibiotic called Clavulin. She said she knew immediately after taking the first dose of Clavulin that something was wrong. The medication made her feel worse, not better.

The same happened with Hannah, the 14-year-old who had a serious bout with SJS that was linked to her bipolar medication trileptal. Hannah said the medication had made her physically ill for weeks before she broke out in painful rashes and blisters. She just didn’t realize it was the trileptal that was making her so ill.

Since writing about SJS, I have learned about the many medications that can cause SJS/TEN. And yes, Ketek is on the list. There have been publicized reports of SJS/TEN related to the antibiotic. Since my trial with Ketek, I have told my doctors not to prescribe it to me.

So, just a word of warning during these days when colds and flu are on the rise. Be aware of the medicines you are prescribed. Read up on the side effects and adverse reactions. And stay safe.

SOURCE: Stevens Johnson Syndrome › Beware of side effects from meds this season

Ralph was rushed to Miami Valley Hospital in Dayton and was diagnosed with toxic epidermal necrolysis, or TEN. TEN is a severe form of the hypersensitivity disorder known as Stevens Johnson Syndrome, or SJS. The condition occurs as a severe reaction to medication and presents as a rash that blisters over, causing the skin to peel off in sheets. Mucus membranes such as those on the eyes and in the mouth also can blister over. Complications include infection, dehydration, blindness and even death.

Phenytoin, made by Mylan Pharmaceuticals and sold under the name Dilantin, was listed as the culprit.

Ralph never recovered. He died on May 27, 2006, from TEN. Amy has since filed a lawsuit against the Mylan Pharmaceuticals and Mylan Inc., on behalf of the estate of her late husband Ralph. Amy says her husband would not have taken the drug had he known of the potential for serious side effects.

The 10-count lawsuit claims the drug maker repeaed huge profits while concealing from the public the dangers of taking Dilatin/Phenytoin. The lawsuit seeks punitive and compensatory damages for Ralph’s injuries, pain and suffering. It also seeks damages to Ralph’s estate.

SOURCE: Stevens Johnson Syndrome › Wife files lawsuit against drug maker

Joe was just 4 years old when he died. He contracted meningitis at one week old and eventually was diagnosed with Angelmans Syndrome, a neuro-genetic disorder that can cause developmental delays, seizures and jerky movements. Those with Angelmans Syndrome appear to have a happy, joyful demeanor. Shortly after the diagnosis, Joe was put on Topiramate, an anticonvulsant to control his seizures. But the medication caused a severe adverse reaction called Stevens Johnson Syndrome (SJS).

“We were warned about the usual side effects – loss of appetite, liver problems, etc., but not SJS,” his family writes in the online journal, Joe Way Inspired.

SJS damaged Joe’s organs and left him vulnerable to numerous infections. His body was frail, but his spirit was strong. His family focused on giving Joe the opportunity to live his short life to its fullest, taking him to the beach and letting him play in the water. Last May, he lost his fight.

Four weeks after Joe died, his family launched the Web site memorial. Its focus is to raise money for a children’s hospice in their town of Cornwall.

Last week, Joe’s family launched a series of videos on YouTube. The videos show the spirit of little Joe and the fund raising efforts of others. The Way family alone has raised more than £28,500 as part of the “children’s hospice South west Precious lives appeal.” Others have helped raise funds as well, making the hospice, which will be named Little Harbour, a reality.

Joe won’t be able to reap the benefits of Little Harbour, but his family has seen the plans for the facility. As Joe’s father said in one video, speaking to a church congregation, “Still, in his own way, he is inspiring people even though he is not here.

SOURCE: Stevens Johnson Syndrome › SJS victim’s family helps raise funds for children’s hospice

Today I read the story of Joe Way of England. He was born just two and a half months before my son, on September 5, 2003. Though an ocean apart, he was not unlike my son. He was born healthy to a loving family. But at a week old, he contracted meningitis and eventually was diagnosed with Angelmans syndrome, a neuro-genetic disorder that can cause developmental delays, seizures and jerky movements. It is so named because those who suffer from the condition appear to have a happy, joyful demeanor. In order to control the seizures, Joe was put on Topiramate, an anticonvulsant.

“We were warned about the usual side effects – loss of appetite, liver problems, etc., but not SJS (Stevens Johnson Syndrome),” his family writes in their online journal Joe Way Inspired.

Joe was taken to the hospital where doctors watched as the mysterious symptoms appeared and the little boy’s health deteriorated. He was eventually diagnosed with SJS, a rare but life-threatening adverse reaction to drugs – such as anti-seizure drugs – that causes the skin and mucus membranes (eyes, mouth, genitals) to blister and peel away in sheets.

“He had experienced bad health throughout his short life, but nothing compares to the horror of SJS,” his family writes.

Details of his story and photos of the beautiful boy are shared on the site, and are much too difficult for this mother to type. Joe did pull through, but his health was badly compromised. He was put on a home ventilation device and his health increasingly deteriorated.

Joe’s family understood that their time with their young son was limited, but they did their best to provide the best at-home care for Joe in order to limit his hospital visits. He was too sick to make it to Little Bridge House, the children’s hospice in Devon, something that deeply affected the family.

After a two-year battle, Joe’s little body finally gave out. He died May 7, 2008, just four months before his 5th birthday. Shortly after, his family published the Web site in his memory, calling for donations to fund a children’s hospice in their town of Cornwall. So far, more than 30,000 pounds has been raised for the Children’s Hospice South West center, called Little Harbour.

“Supporters pondering the plans will see a slate roof, Cornish stone walls, and a tower reminiscent of the many lighthouses surrounding the Plymouth and Cornish coastline, and designed to reinforce the hospice’s Cornwall and Plymouth connections. They will also discover the special children’s bedrooms, accommodation for parents and siblings, a wide range of play and therapy facilities – including a messy play area, a Jacuzzi, and a multi-sensory room – and a homely family kitchen and living room which are all designed to help create a comfortable and wonderfully caring community,” the site details.

Donations can be made online at www.joeway.co.uk.

“It is critical to ensure life limited children get this support in Cornwall,” writes his family.

SOURCE: Stevens Johnson Syndrome › Family raises funds for children’s hospice after son dies from SJS

Kazuyuki Ogura of Kawasaki was a victim of a serious side effect from common over-the-counter medicines. Weeks after the 37-year-old man took cold medicine for a day, he came down with a high fever, rash and bloodshot eyes. He was diagnosed with Stevens Johnson Syndrome (SJS). Ogura survived this potentially deadly but rare reaction to medication, but it was a year and a half before he was able to return to work. His vision is still not up to par. “No one had ever told me that over-the-counter drugs carried such risks, “ he told the newspaper.

Those who oppose the restrictions – the Japan Online Drugstore Association (JODA), Rakuten and Yahoo – have petitioned the Minister of Health, Labor and Welfare to stop the proceedings. JODA and the Internet giants argue that stricter online regulations will crush the 26-billion-yen online and mail-order drugstore market. The revised law will ban “class 3” drugs that include some cold medications and painkillers. Opponents say that this ban will prevent people from also purchasing products they would be embarrassed to buy at stores, such as baldness remedies and pregnancy tests.

The Japanese Pharmaceutical Association, the Japan Association of Chain Drug Stores (JACDS), and the Cabinet’s Council for the Promotion of Regulatory Reform support the stricter regulations, citing the inability of online drug stores to guarantee the safety of their drugs.

SOURCE: Stevens Johnson Syndrome › Revised Japanese law limits online purchases of drugs

Researchers centered their focus on antibiotics that were either ingested or injected rather than those that are applied to the skin. Data was pulled from the National Ambulatory Medical Care Survey, National Hospital Ambulatory Medical Care Survey, National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project. The data showed that 19 percent of all emergency visits for adverse reactions to drugs were due to antibiotics.

Seventy-eight percent of the time those adverse events were caused by allergic reactions to the antibiotics and resulted in rashes and anaphylaxis. Other causes were accidental overdoses, unintentional exposures (such as children accidentally taking the medication), and side effects such as headaches, dizziness and diarrhea.

Stevens Johnson Syndrome (SJS) is a rare but serious reaction to medication including antibiotics such as sulfonamides and penicillin. It is defined as a hypersensitivity disorder affecting the skin and mucous membranes and expresses itself first as a simple rash known as erythema multiforme.

Penicillin and similar-type antibiotics accounted for the majority of adverse events that resulted in emergency room visits, with penicillin alone attributing 36.9 percent of the visits. For every 10,000 outpatient prescription visits, reactions to sulfonamides resulted in 18.9 of emergency room visits. Sulfonamides also had a much higher rate of moderate-to-severe allergic reactions compared to medications in other antibiotic classes.

According to Dr. Daniel S. Budnitz, the leader of the study, “Antibiotics are among the most frequently used medications in the United States. Annually, antibiotics are prescribed to an estimated 16 percent of patients during ambulatory care visits, and pharmaceutical manufacturers spend $1 billion promoting antibiotics.” The report continues, “more than one-half of the estimated 100 million antibiotic prescriptions written in the community each year for respiratory tract infections may be unnecessary.”

SOURCE: Stevens Johnson Syndrome › Most emergency visits from drug reactions caused by antibiotics

The FDA approved Celgene Corp.’s Revlimid in December 2005 to treat a bone marrow disorder. It was later approved for use in treatment of multiple myeloma, a type of blood cancer. Earlier this month, Revlimid appeared on a list of approximately twenty drugs under investigation by the FDA for possible safety hazards. No details about the specific concerns were made available at that time.

From the drug’s approved use in 2005 to January 23, 2008, the FDA received 14 reports of serious skin reactions following Revlimid therapy. Three deaths occurred among the 14 patients who displayed either SJS or TEN, although progression of cancer is suspected in one of the fatalities.

The estimated incidence of SJS/TEN is 1 to 2 persons per million annually. According to Brian Gill, a spokesman for the manufacturer of Revlimid, approximately 60 thousand people have been treated with the drug. Individuals with SJS normally have 10-30 percent of their body surface area affected by the disorder. SJS-related mortality is estimated to be between 1-3%. People with TEN normally suffer an infliction of more than 30% of their body’s surface area. Mortality ranges anywhere from 10-70%, according to the FDA.

Revlimid currently comes with warnings of other serious hazards, including birth defects and blood clots and is distributed, sold, and used with great restriction. The drug’s labeling will be updated to include reports of skin reactions and doctors are strongly advised to discontinue use in patients that develop skin irritations while taking Revlimid.

SOURCE: Stevens Johnson Syndrome › FDA finds link between Revlimid and skin diseases

“SAEC’s focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event,” Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday.

The findings of the consortium could have an impact on improving the ability of patients to safely use existing drugs, Holden added. “We hope it will improve the productivity and effectiveness not only for those who develop drugs but for those who regulate drug development,” he said.

“The immediate goal would be to develop a test that could identify who will have a problem with a drug before they get it,” said Dr. Paul Watkins, director of the General Clinical Research Center at the University of North Carolina in Chapel Hill. “The ultimate goal is to look at the genes that are causing the susceptibility and work back to figure out how we can design drugs differently so that no one would have that problem,” he added.

“The two drug reactions that are being studied, Stevens-Johnson and liver toxicity, are very common reasons for problems with drugs either being restricted, not being developed, not being approved or being pulled off the market,” said Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer at the U.S. Food and Drug Administration.

“This effort is part of personalized medicine — personalized safety — that will make treatments safer by understanding individual benefits and risks,” she added. “This will help in the development of drugs both in avoiding these side effects in the future and maybe developing tests to help identify people at high risk,” she said.

Findings from these studies could lead to the FDA requiring genetic tests to determine risk before the drug is prescribed, Woodcock added.

A recent survey found that most Americans are more concerned with drug safety than with speeding more medications to the marketplace.

Members of the consortium include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Pfizer, Roche, Sanofi-Aventis and Wyeth. In addition, the FDA will consult on the design and conduct of SAEC studies.

The actual research will be done at academic centers in Europe and the United States.

The results of the studies will be made public domain, and none of the companies will have early access or be allowed to patent the findings. When the results are made public, any company can develop and sell the genetic tests that predict side effects.

SAEC is one of several consortiums formed by the pharmaceutical industry to conduct basic research. One of the first was started in 1999 and was headed by Holden. That consortium looked for DNA variations among people. Their data were also put into the public domain.

October 17th, 2007

SOURCE: Stevens Johnson Syndrome › Drug industry seeks tests to spot side effect risks