Detrol is just one of the medications that has been added to the Food and Drug Administration (FDA) quarterly report on treatments identified as a potential safety risk to patients. According to the report, Detrol, also known as Tolterodine Tartrate, is being evaluated by the agency after reports of patients diagnosed with Stevens Johnson Syndrome (SJS), a rare but life-threatening skin condition, after taking the medication.

SJS and its most severe form, toxic epidermal necrolysis (TEN), are severe adverse reactions to medications. More than 200 medications have been linked to the condition. Those who suffer from SJS or TEN experience rashes that blister over and cause the skin to peel off in sheets. Blisters can also form on the eyes, inside the mouth and on internal organs, causing ocular problems, dehydration, infection and sometimes death.

Other medications listed in the FDA’s quarterly report and investigated for a possible link to skin reactions include hydrochlorothiazide in combination with other products, sleep disorder medications modafinil (Provigil) and Armodafinil (Nuvigil), and smoking cessation drug Chantix.

The FDA reports that it is continuing to evaluate these issues to determine if there is need for regulatory action. In the interim, the FDA emphasizes that the listing of a drug and a potential safety issue does not mean that the medicines should not be prescribed nor that patients taking those drugs should stop taking the medication. Patients with questions about their medication should contact their health care provider.

Source: FDA

SOURCE: Stevens Johnson Syndrome › New drugs investigated for possible skin 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

SJS and TEN are severe adverse reactions to medication that first express as rashes on the skin. The rashes blister over causing the skin to peel away. Mucus membranes in the eyes, mouth and nose also can be affected and cause serious complications such as dehydration, infection and even death. Serious ocular complications may include permanent vision loss from corneal scaring or vascularization.

The study involved 159 patients over an 8-year period who had been diagnosed with SJS and TEN. Seventy-four percent of the group had acute ocular involvement. Patients with TEN had more frequent but not more severe acute ocular involvement. Sixty-three percent had late ocular complications, with dry eye being the most common complication.

The researchers determined that the severity of the acute ocular disease was found to be the only significant predictor of late complications. The authors suggest that all patients with SJS or TEN undergo initial ophthalmologic screening and follow-up during the acute phase of the disease and that prospective follow-up for up to a year may be necessary.

SOURCE: Stevens Johnson Syndrome › Study focuses on eye complications from SJS/TEN

SJS and TEN are serious reactions to medication that present with a rash on the skin that blisters over causing the skin to keep off in sheets. Mucus membranes such as those on the eyes and in the mouth also can blister, leading to life-threatening complications. If signs and symptoms are not quickly recognized and the medication causing the problem not identified and stopped, the reactions can be fatal.

SAEC is a nonprofit organization made up of major pharmaceutical companies and academic institutions focused on research relating to the genetics of drug-induced serious adverse events. Organized 16 months ago, the group’s mission is to develop genetic tests that can identify which patients are more likely to suffer severe adverse reactions to medication. Much of the group’s focus is on SJS/TEN.

The group’s findings were derived by pooling serious skin rash cases and control samples from GlaxoSmithKline plc London, U.K. From that data, researchers identified numerous genetic associations that may increase one’s chances of having a serious skin reaction to medication.

“This consortium has taken a significant step forward by promoting open sharing of drug safety data. This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient’s risk for experiencing an adverse drug event,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research.

The group’s initial research results will be published later this year.

SOURCE: Stevens Johnson Syndrome › SAEC releases first data on serious adverse events caused by drugs

The disease is a contagious respiratory illness. Symptoms usually start suddenly and may include a high fever, headache, tiredness, cough, sore throat, runny or stuffy nose, body aches and diarrhea and vomiting.

One way doctors help patients treat and prevent the flu is with TAMIFLU. Roache Laboratories, the company that makes TAMIFLU, says it is the No. 1 doctor-prescribed flu medication for the treatment of the flu for patients who have been symptomatic for no more than two days.

The medication is approved for both adults and children aged 1 year and older. But according to its safety labeling, and an announcement by the U.S. Chamber of Commerce, during post-marketing rare cases of Stevens Johnson Syndrome (SYS) and toxic epidermal necrolysis (TEN) have been reported by patients using TAMIFLU.

SJS and TEN are serious adverse reactions to medication. There are more than 200 types of medications that have been linked to SJS/TEN, most commonly ibuprofen, antibiotics and anti-seizure medication. The reaction begins with a rash on the skin that blisters over and causes the skin to peel off in sheets. Mucus membranes, such as the eyes and mouth, can blister over leading to serious health concerns such as dehydration, infection, blindness and even death. TEN is the most severe form of SJS, and carries a fatality risk of up to 30-40 percent.

Patients who experience a severe adverse reaction to medication they are taking are encouraged to contact their healthcare provider immediately or go to the emergency room.

SOURCE: Stevens Johnson Syndrome › TAMIFLU carries risk of serious adverse reaction

Ethyol is a prescription medication given by injection before postoperative radiation treatment sessions for head and neck cancer to lower the rate of moderate to severe dry mouth, also known as xerostomia. It is often prescribed when radiation includes the parotid glands, or the largest of the salivary glands.

The changes to contraindications and warnings for Ethyol include a warning of cutaneous reactions including erythema multiforme, SJS, TEN, toxoderma and exfoliative dermatitis. The reactions have been reported most frequently when Ethyol is used to protect against the effects of radiation. According to the new safety labeling information, some of the cutaneous reactions have been fatal or have required hospitalization and/or discontinuance of therapy.

Patients receiving injections of Ethyol should be carefully monitored as serious cutaneous reactions may develop weeks after initial use, according to the revised labeling.

The new labeling changes were approved by the FDA Center for Drug Evaluation and Research last November.

SOURCE: Stevens Johnson Syndrome › Ethyol now linked to SJS, TEN

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

Darunavir, manufactured by Tibotec, belongs to a class of anti-HIV drugs called protease inhibitors (PI). It works to prevent cells infected by HIV from producing new virus, thus reducing the amount of virus in the body. Darunavir must be coadministered with 100-mg ritonavir and with other antiretroviral agents. It was approved by the FDA in June 2006 for HIV-positive adults who were treatment-experienced.

Last October, darunavir was approved for HIV-positive individuals beginning treatment. The medication has proven effective for patients who are not likely to respond to older PIs and for those who are starting antiretroviral therapy for the first time.

SJS and its more severe form, toxic epidermal necrolysis (TEN), are serious adverse reactions to medication. The reaction begins with a rash that blisters over, causing the skin to peel off in sheets. Mucus membranes in the eyes and mouth also can blister over, leading to dehydration, infection, blindness, and even death. More than 200 medications have been linked to SJS and TEN, including NSAIDs such as ibuprofen, antibiotics and anti-seizure medication.

Other warning included in the labeling revisions for darunavir include warnings of potential drug-drug interactions and pregnancy risk. Darunavir should not be taken with dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, St. John’s Wort, lovastatin, simvastatin, or rifampin.

Darunavir also should be taken during pregnancy only if the potential benefit justifies the potential risk, according to the report. Mothers on darunavir should not breast feed, and children younger than 3 should not take darunavir.

SOURCE: Stevens Johnson Syndrome › HIV medication carries warning of SJS

SJS and TEN are hypersensitivity disorders that affect the skin and mucus membranes. It begins as a rash that blisters over, causing the skin to peel off in sheets. The mouth, eyes and other orifices can be affected with blisters as well. The condition can be life-threatening.

Oxcarbazepine is relatively new anti-seizure treatment for epilepsy. It works by blocking the channels that electrical signals use to get into brain cells. According to the update, individuals treated with oxcarbazepine who experienced the reactions had a fever and a rash. Some patients had enlarged lymph nodes and some experienced symptoms such as itchiness and joint pain. The rash usually appeared within three weeks of starting treatment with oxcarbazepine.

More than 200 medications have been linked to SJS and TEN. Many anti-seizure medications have been associated with the severe reactions. Those on oxcarbazepine or any other treatment for epilepsy should contact their doctors immediately if they experience any of the warning signs of SJS or TEN, including raised lumps, flaky skin, swollen face, painful skin, purple blotches, sores on the lips or inside the mouth, or any asthma symptoms such as wheezing and difficulty breathing.

SOURCE: Stevens Johnson Syndrome › Oxcarbazepine/Trileptal epilepsy meds linked to SJS/TEN

Currently, the SAEC is conducting a study that addresses Stevens Johnson Syndrome (SJS). SJS is a rare but life-threatening reaction to medication. SJS affects the skin and mucus membranes, causing blisters to form on the skin and the skin to peel off in sheets. Blisters also can form on the mouth and eyes, causing serious eye complications and even blindness. SJS is linked to more than 200 medicines. Most often SJS is linked to ibuprofen, antibiotics and anti-seizure medication.

Researchers for the SAEC project will look for genetic variations linked with SAEs from the SNP Consortium and the Human Genome Project’s Hap Map Project.

“The traditional research model only provides one piece of the puzzle in understanding the genetic variations that could lead to an increased risk of an adverse event. Because of the number of patients needed to tie a genetic variant to an SAE, and the resulting cost of doing these studies, no one company, research center, or agency can efficiently conduct this research on its own. The most efficient way to study drug-related SAEs is to create a global, publicly available ‘knowledge base’ that will help identify the genetic variations that may predict SAEs,” SAEC Chairman and CEO Arthur Holden said in a September 2007 announcement in Highlight Health, when the consortium was formed.

The SAEC research study will be made available within 12 months of completion. If initial studies are successful, the consortium vows to study every major SAE to find its genetic cause.

SOURCE: Stevens Johnson Syndrome › Consortium studies genetic markers, hopes to predict SJS

Health Canada recently updated its report of adverse reactions to some of the more common herbal products, including Echinacea, ginko and St. John’s Wort. According to the report, some people have reported experiencing rashes after taking St. John’s Wort. St. John’s Wort is an herbal treatment for major depression and is available over the counter in the U.S.

Ginseng is another common herb readily available in the U.S. Ginseng is a stimulant taken orally to treat type II diabetes and sexual dysfunction in men. Ginseng also can be found in some popular energy drinks and foods. Studies show that ginseng has been linked to at least one occurrence of Stevens Johnson Syndrome (SJS), a severe adverse reaction to medication.

SJS usually begins with a fever and sore throat and progresses to rashes that cover the skin and mucous membranes. As the condition progresses, the rashes can blister over and cause the skin to fall off in sheets. The mouth and eyes also can blister, which can lead to dehydration, infection and serious eye problems and even blindness.

The International Journal of Pediatric Dentistry also reports that a 10-year-old Indian boy developed severe mouth and eye ulcers and was subsequently diagnosed with SJS after taking an “herbal medication of plant origin” prescribed by a traditional healer for treatment of a fever. According to the book, traditional therapy with herbal preparation (Ayurvedic medicine) is not uncommon in India.

Doctors advise those who experience symptoms of SJS to go immediately to the emergency room.

SOURCE: Stevens Johnson Syndrome › Herbal remedies may cause severe adverse reactions

Modafinil (Provigil) is approved by the FDA to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnea. Modafinil (Provigil) also has been shown effective in the treatment of depression, cocaine addition, Parkinson’s Disease and schizophrenia, though the FDA has not approved the drug for those conditions. It also was thought to be an effective treatment for Attention-Deficit Hyperactivity Disorder (ADHD), however in 2006 it was rejected by the FDA for use by children for ADHD. Cephalon now discourages the drug’s use in children for any purpose.

Since December 1998, when Modafini (Provigil) was introduced to the market until January 30, 2007, seven cases of seven cases of severe cutaneous adverse reactions to the medicine were reported to the FDA. Those cases included SJS and its more severe form, toxic epidermal necrolysis (TEN).

SJS and TEN has a reported incidence rate of about one case per million people each year. It is most often caused by an adverse reaction to medication. Medications that have been linked to SJS and TEN include NSAIDS (non-steroidal anti-inflamatory agents), anti-seizure medications and some antibiotics.

SOURCE: Stevens Johnson Syndrome › Stimulant drug added to list of meds that can cause SJS/TEN

Young Ian clung to life as 90 percent of his skin peeled away and his lungs and digestive tracts were burned. He beat the odds and survived, but his eyes were adversely affected. He suffered such mounting pain from ulcers and inflammation in the eyes that one Alberta physician suggested Ian’s eyes be removed to alleviate the pain. It was not an option Ian’s mother was willing to accept.

Over the past seven years, Ian has had 38 surgeries to correct his vision. Many of those years were spent in the dark. His last surgery, in October, has enabled him to see much more clearly and has restored his depth perception. Because SJS ate away the protective film over his eye, he now wears a deep contact lens to prevent his eyelid from collapsing onto his cornea.

It is a long and grueling road to recovery, but today 10-year-old Ian’s body shows few signs of SJS. His skin, treated by vitamin E capsules, has grown back, and – following doctor’s orders – he plays video games for two hours a day to exercise his eyes.

SOURCE: Stevens Johnson Syndrome › Canadian boy’s family still fighting to save eyes harmed by SJS

Kim experienced a rare reaction to the antibiotic that started with a headache and progressed quickly to toxic epidermal necrolysis (TEN), a severe form of Stevens Johnson Syndrome (SJS), a reaction to medication where the skin blisters and peels off. Ninety percent of the time the reaction is caused by drugs such as ibuprofen, antibiotics and anti-seizure medications.

Kim lost 70 percent of her skin and was put into a drug-induced coma. She was given a 30 percent chance of survival by one doctor. She managed to beat the odds, and was released from the hospital this week.

“Why aren’t people told that they could die if you have a reaction to this drug?” Kim’s father, Art Oake, posed to CBC News.

Nearly one in a million Canadians are treated for SJS/TEN each year. One in six die, according to the story. Toronto dermatologist Dr. Neil Shear urges patients who take antibiotics or drugs used to treat epilepsy to look for signs of adverse reactions, such as fever, tender skin and blistering or sores in the mouth. Patients who experience any reaction should stop taking the drug immediately and call their doctors, he said.

SOURCE: Stevens Johnson Syndrome › Father asks why he wasn’t warned of possible reaction to drug

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

In a recent Information for Healthcare Professionals sheet, the FDA described the increased risk of SJS/TEN with another antiepileptic drug, carbamazepine, in patients of Asian ancestry with the HLA-B*1502 allele. HLA-B is a human gene that provides instruction for making a protein that plays a critical role in the immune system. It is part of a family of genes called the human leukocyte antigen (HLA) complex. This complex helps the immune system distinguish the body’s own proteins from proteins made by viruses or bacteria. Several variations of the HLA-B gene are associated with adverse reactions to certain drugs.

SJS is a disorder of the skin and mucous membranes and often begins with flu-like symptoms followed by inflammation of mucous membranes and a painful red or purplish rash that spreads and blisters. It eventually causes the top layer of skin to die and shed.

Until the FDA completes its review, the agency warns healthcare providers who are considering the use of phenytoin or fosphenytoin for their patients to be aware of the risks and benefits described in the current prescribing information for the drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

SOURCE: Stevens Johnson Syndrome › FDA warns of link between anti-epilepsy drugs and SJS