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

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

One such resource is an online survey designed to develop an international SJS/TEN registry with the goal of lobbying the federal government for a mandatory reporting system of all adverse drug reactions. You can help the Foundation reach this goal by filling out the survey.

Another valuable tool is the direct link to the FDA’s MedWatch: Reporting by Consumers link that easily enables consumers to report any serious reactions to drugs and medical devises. While individuals are encouraged to report these reactions to their health care provider so that the information can be evaluated based on your medical records, that step is not required. Consumers can simply complete the online form and report the incident directly to the FDA.

SJS/TEN is a rare but life-threatening hypersensitivity condition most often caused by common medication, including ibuprofen, antibiotics and anti-seizure drugs. It affects the skin and mucus membranes marked by a rash on the skin that blisters over and peels away in sheets. The mouth, eyes and other orifices can be affected causing dehydration, infection and serious eye problems such as blindness.

SOURCE: Stevens Johnson Syndrome › SJS support site offers valuable resources to those affected

The Stevens Johnson Syndrome Foundation was founded as a community for adults and children affected by the condition. It is a 501(c)3 nonprofit organization dedicated to promoting public awareness to adverse drug reactions. Tax-deductible donations help power the organizations Web site and enable its members to raise awareness of the condition and provide much needed support to others suffering from SJS and TEN.

One of the organization’s outreach projects aims to provide comfort to the tiniest sufferers of SJS and TEN. For a tax-deductible donation of $30, the organization provides a plush bear and blanket to a child with SJS and TEN.

For more information about this important cause visit the SJS Foundation’s Donation Center. To participate in the bear & blanket program, send your $30 check payable to the Stevens Johnson Syndrome Foundation, P.O. Box 350333
 Westminster, CO 80035-0333,
 USA. Please include “SJS Kids Comfort” in the memo section. Other donation opportunities also are detailed on the Web site.

SOURCE: Stevens Johnson Syndrome › Bear and blanket program gives comfort to kids with SJS

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

Julie McCawley became a victim of SJS when she was just 11 months old. Her mother, Jean McCawley, established the SJS Foundation in 1995 to provide the public and medical communities with information about the adverse allergic drug reactions and to serve as a support outlet for victims of SJS and their families. Today, Julie is 14 years old and as a result of SJS has lost vision in one of her eyes.

Last August, Julie designed a Web site to help educate the public about SJS from a child’s perspective. The SJSKIDSSUPPORT.org site uses cartoons and plain language to explain the disorder. “I hope that it gives healthy kids some insight into why SJS kids may look different on the outside or why many of us are so sensitive to the sun, but that we’re the same on the inside. Then, maybe the next time they meet a person with SJS or any kind of disability, they will be more tolerant of someone who’s not exactly like them,” Julie says in a recent press release.

The Web site also honors the memory of children who have lost their battle with SJS. “The idea for this really is an extension of a special bulletin board that I keep at home that has the photos of children who have died from SJS. Their beautiful faces and tragic stories remind me that we need work harder at educating everyone about the dangers of SJS,” she adds.

Julie’s story can be found on the Foundation’s Web site at www.sjsupport.org. The SJS Foundation sponsors active support groups in 18 states, and through its Yahoo support groups serves adults and children afflicted by SJS from around the world, including Australia, Canada, Europe, Mexico and South Africa.

SOURCE: Stevens Johnson Syndrome › Young SJS victim creates Web site for children with SJS

According to mediafact.com, other medications have been linked to Stevens Johnson syndrome including Bextra, Celebrex and Daypro, as well as over-the-counter pain relievers such as Motion, Ibuprofen, Children’s Motrin and Advil.

One of the main issues with Stevens Johnson syndrome is the lack of awareness from the patients that are at risk and the doctors that prescribe the medication. In a 2007 press release from SmartBrief.com, Governor Bill Ritter, Jr., of Colorado, along with the Stevens Johnson Syndrome Foundation, recognized August 2007 as the designated SJS Awareness month. Joining Colorado in recognizing this month were Arizona, Alabama, Connecticut and Tennessee.

According to the article, Stevens Johnson Syndrome affects more than two million Americans each year and has resulted in more than 140,000 deaths.

When prescribed a new medication, or even taking over-the-counter medication, educate yourself on Stevens Johnson Syndrome so you can identify the symptoms at the earliest possible stage.

SOURCE: Stevens Johnson Syndrome › Drug reactions bring awareness to Stevens Johnson Syndrome

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