Health Canada

Health Canada issued the warning based on adverse event reports in Canada and other countries of consumers using Champix suffering suicide-related events or the worsening of existing psychiatric disorders. The new warning says the drug should be discontinued and a doctor consulted immediately if caregivers or family members notice atypical behaviors in Champix users or if users develop a skin rash. SJS begins as a rash that blisters over causing the skin to peel off. The eyes, mouth and internal organs can also be affected, causing serious problems including dehydration and ocular problems.

In May 2008, Pfizer updated its safety information on Chantix to warn of possible serious psychiatric symptoms. In 2009, the FDA announced it was evaluating Chantix again, this time for additional side effects including serious skin reactions and accidental injury. As a result, the FDA placed a black box warning on the drug, the agency’s strongest safety warning, because of the risk of depression, suicidal thoughts and suicidal actions.

SOURCE: Stevens Johnson Syndrome › Health Canada issues stronger warnings about Chamtix,Chantix

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

The new information, gathered from a clinical study and postmarketing reports, revealed sometimes fatal incidences of gastrointestinal perforation, bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens Johnson Syndrome (SJS) and/or toxic epidermal necrolysis (TEN) and ocular disorders including corneal perforation or ulceration.

SJS/TEN is a rare but life-threatening reaction to medication that presents with a rash that blisters over, causing the skin to peel off in sheets. It can also affect the mucus membranes, causing blistering and ulceration of the mouth, eyes and internal organs. Several commonly used medications have been linked to SJS/TEN including ibuprofen, antibiotics and antiviral drugs.

Tarceva is used in the treatment of locally advanced or metastic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. It is also indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

The updated WARNINGS AND PRECAUTIONS section of the labeling reflects dose interruption and/or discontinuation instructions. For any questions, or to report adverse events suspected to be associated with the use of Tarceva, call 1-877-TARCEVA (1-877-827-2382).

Alternatively, adverse event information may be reported to the FDA’s MedWatch reporting system by phone at 1-800-FDA-1088, by facsimile at 1-800-FDA-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857, or by the internet at http://www.fda.gov/medwatch/index.html.

SOURCE: Stevens Johnson Syndrome › New SJS warnings added to cancer treatment drug

Cephalon, makers of Treanda, has filed documents with the Securities and Exchange Commission this week stating it will update its prescribing information for the Treanda drug to include a warning of the possibility of SJS when used with allopurinol, a medication used to treat excess uric acid in the blood plasma, according to the Philadelphia Business Journal.

According to the documents, two patients treated with Treanda and allopurinol were diagnosed with SJS. One of the two died.

SJS is a rare but life-threatening condition in which a rash forms on the skin and blisters over. The skin peels off, leaving the skin exposed to infection. Blisters also can form on mucus membranes such as the eyes and mouth, which can lead to dehydration and vision problems. More than 200 medications have been linked to SJS.

“Although the relationship between Treanda and Stevens Johnson Syndrome cannot be determined, there may be an increased risk of severe skin toxicity when Treanda and allopurinol are administered concomitantly,” Cephalon stated in its filing, adding that allopurinal is known to cause the syndrome.

The updated prescribing information is expected to be implemented in early May.

SOURCE: Stevens Johnson Syndrome › Cancer drug’s prescribing information to include warning of SJS

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

Intelence is a tablet available only by prescription. It is a type of anti-HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI), also known as a non-nuke. It is used to control HIV infection in adults and must be used in conjunction with other HIV medications. Intelence is for patients who have previously received treatment for HIV-1 and showed resistance to NNRTIs and protease inhibitors.

The clinical trials revealed that Intelence does carry a slight risk for serious skin reactions such as Stevens Johnson Syndrome (SJS), hypersensitivity reaction and erythema multiforme.

More than 200 medications have been linked to SJS and its more severe form, toxic epidermal necrolysis (TEN), most commonly ibuprofen, antibiotics and anti-seizure medications. SJS and TEN are severe expressions of a simple rash known as erythema multiforme. As the condition worsens, the rashes blister over causing the skin to peel off. Mucus membranes, such as the mouth and eyes, can blister over causing dehydration, infection, blindness and even death.

Patients taking medication, including Intelence, should be aware of the potential life-threatening risk of SJS/TEN

SOURCE: Stevens Johnson Syndrome › HIV treatment linked to slight risk of SJS/TEN

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

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

GIST are rare tumors that usually appear in the stomach or small intestine. They tend to be resistant to chemotherapy, and are considered aggressive cancers. Re-occurrences of GIST tumors tend to be more aggressive and are associated with lower survival rates.

The new treatment, Glivec, is the only post-surgery treatment that has been shown to delay the return of this deadly cancer. In studies conducted, Glivec was proven effective in more than 9 out of 10 patients who received the medication based on a 14-month follow up. Data sponsored by National Cancer Institute showed that 91.6 percent of patients on Glivec therapy remained cancer-free after a 14-month follow up compared to 80.2 percent of patients who took a placebo.

Glivec also is approved for the treatment of Philadelphia chromosome-positive myeloid leukemia, Kit-positive gastrointestinal stomal tumors which cannot be surgically removed or have metastasized, and other rare diseases. Regulatory reviews are currently underway in the European Union and Switzerland.

SJS has been listed as a rare adverse reaction to Glivec. SJS is a rare but life-threatening reaction to medication. It begins with a rash on the skin that blisters over, causing the skin to peel away in sheets. Blisters can also form on the eyes and mouth, leading to dehydration, infections and serious eye problems. The condition can be fatal.

SOURCE: Stevens Johnson Syndrome › Glivec proven effective in treatment of GIST, but linked to SJS

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

In a recent post on her blog, Sight for Sore Eyes SJS, the mother of a boy who had been diagnosed with toxic epidermal necrolysis (TEN), the most severe form of Stevens Johnson Syndrome (SJS), ranted about the updates to over-the-counter medications to kids. The warnings, she said, were nondescript and did not adequately portray the dangers that could occur when taking the medication, like the reaction her son had when he was just 3. For Helen, a more reasonable warning label would read: “If your child survives the most agonizing drug reaction, they will live with intense pain and vision loss for the rest of their lives.”

Helen would know. Ian was 3 years old when he was diagnosed in 2001 with TEN. Ninety percent of his skin peeled away and his lungs and digestive track burned and his eyes blistered. He hung on the edge of life before slowly and miraculously recovering. His skin gradually healed but his eyes were adversely affected. He suffered extreme pain and blindness.

Since his diagnosis, Helen has done everything in her power to give Ian a healthy life, from moving across country to seeking out medical treatment to help him see again. Her blog is a regular testament to her dedication to raise awareness of the ill affects of some common medications so others don’t suffer the way Ian has. Keep up the great work, Helen!

SOURCE: Stevens Johnson Syndrome › Mother offers sight for sore eyes

Researchers like Wen-Hung are asking why.

SJS is a life-threatening hypersensitivity condition that causes rashes to form over the body. The rashes blister over, causing the skin to peel off in sheets. SJS also can affect the mucus membranes, causing blisters to form in the mouth and eyes. Death can result in about 10 percent of patients with SJS. If it progresses to its most severe form, toxic epidermal necrolysis, (TEN) the death rate soars to 40 to 50 percent. SJS/TEN is linked to more than 200 medications, most commonly ibuprofen, antibiotics and anti-seizure medication.

A group of Chang Gung researchers were aware that the anticonvulsant carbamazepine was linked to many cases of SJS, but through its own study using Taiwanese patients, researchers discovered a possible connection – “a high correlation between hypersensitivity to carbamazepine and a single allele, human leukocyte antigen B1502,” according to the report. As many as 80 percent of Taiwanese carry the allele. The discovery lead to an FDA warning in the U.S. of the increased risk of SJS/TEN for patients of Asian ancestry with the B1502 allele who take carbamazepine.

Since the discovery, researchers began focusing on developing a test to determine whether a patient has the B1502 allele, and lead researcher Wen-Hung turned his attention on a treatment to halt the progression of SJS/TEN.

SOURCE: Stevens Johnson Syndrome › Taiwanese researchers pinpoint genetic marker for SJS

The latest drug to make this list is bendamustine, marketed under the names Teanda in the U.S. and Ribomustin. Bendamustine was first approved by the FDA for treatment of CLL in March 2008 and for NHL in October 2008. It is the first drug approved to treat CLL since 2001.

According to the report, one case of TEN was reported following the use of bendamustine in combination with rituximab, a chimeric monoclonal antibody. TEN has been previously reported for rituxima. Bendamustine’s relationship to TEN has not been fully determined. The label urges healthcare providers: “Where skin reactions occur, they may be progressive and increase in severity with further treatment. If skin reactions are severe or progressive, Treanda should be withheld or discontinued.”

SOURCE: Stevens Johnson Syndrome › New labeling for CLL, NHL drug includes TEN warning

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

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

But the blisters got worse. They spread down her throat and little Julie was unable to drink her bottle because of the pain. Jean rushed her daughter to the hospital, where doctors continued to administered the phenobarbatol for her seizures. But Julie’s health continued to decline. Four days later the little girl’s lungs collapsed and her skin began coming off in sheets. That’s when a nurse realized what was going on. “This is Stevens Johnson Syndrome (SJS),” she said. Jean was relieved to have a diagnosis, but the doctor said, “This is extremely serious. She could die.”

Jean shared her story earlier this year to Voice America’s Disability Matters radio show with host Joyce A. Bender. Jean appeared on the show with SJS survivor Elizabeth Boxer and her father Mark.

When Jean’s daughter was diagnosed with SJS, she was told the adverse reaction to medication such as anti-seizure medication, ibuprofens and antibiotics was so rare that she would probably never hear of it again. But Jean refused to believe that the illness that threatened her daughter’s life and left her blind in one eye and visually impaired in the other – a condition caused by common medications – was as rare as doctors described. She made it her mission to found a community where others touched by SJS could share their stories. Thus, the Stevens Johnson Syndrome Foundation was established.

Shortly after founding the organization, Jean discovered that several people were suffering from the disease. Many, like Jean, were looking for answers as to how medicine designed to help can actually cause more harm.

“This is wrong,” announced Jean on the radio program, where she took questions from listeners. “(SJS) is not rare. What’s rare is having it reported to the FDA.”

SOURCE: Stevens Johnson Syndrome › SJS Foundation established to give answers to those with SJS

The Johnson family claimed that Children’s Motrin caused their daughter’s skin to break out in excruciatingly painful rashes and blisters after giving her three doses of the over-the-counter medication. Her eyes blistered over and she was blinded. Sabrina, who was 6 at the time, was diagnosed with Stevens Johnson Syndrome (SJS), which is an extreme adverse reaction to some drugs, including ibuprofen. The active ingredient in Children’s Motrin is ibuprofen.

The family claims that the drug maker did not provide adequate warning of the possible reaction on its medication label. A jury found that the medication’s labeling, which advises consumers to notify a doctor if the child’s symptoms change, was adequate.

“The FDA is not doing anything for us. They are taking care of the prescription drug people. They’re taking care of their billions of dollars. And the few children that die … Oh well,” Joan said in the news report.

The Johnson family is appealing the case. At least nine other lawsuits have been filed by others who have suffered from SJS after taking the medication.

SOURCE: Stevens Johnson Syndrome › Family appeals case against makers of Children’s Motrin

Lamotrigine is an anticonvulsant drug to treat partial seizures, primary and secondary tonic-clonic seizures in epilepsy and seizures associated with Lennox-Gastaut syndrome. It also is FDA-approved to treat bipolar disorder.

Peer View cited a session presented at the American Epilepsy Society’s annual meeting, which detailed a study, conducted between January 2000 and December 2007, involving 403 children treated with lamotrigine in addition to existing therapy. Twenty-one of the children in the study experienced adverse skin reactions including moderate diffuse mascular-papular or erythematous rash, severe urticarial skin eruption and mild Stevens Johnson Syndrome (SJS).

There were no cases of toxic epidermal necrolysis (TEN), a severe form of SJS, however the medication has a black box warning about life threatening skin reactions, including SJS and TEN. The manufacturer says the reactions usually occur in the first 2 to 8 weeks of therapy and if medication is suddenly stopped and then resumed at its regular dosage.

According to Rx List, the incidence of these serious skin rashes in response to therapy for epilepsy is about 8 in 1,000 in pediatric patients younger than 16 years of age and about 3 in 1,000 in adults. For treatment of bipolar disorder and other mood disorders, the rate is about 1.3 to 8 in 1,000 for adults.

SOURCE: Stevens Johnson Syndrome › Risk factors may indicate serious skin reaction to lamotrigine

Chung Wen-hung with Chang Gung Memorial Hospital in Taipei, has discovered that granulysin, a naturally occurring substance in the human body, can attack foreign substances or organisms. This discovery may lead to a therapeutic target for further development of an effective treatment for severe immune-mediated disorders that currently have no satisfactory treatment, according to the report. The report is published in last week’s edition of the biomedical research journal Nature Medicine.

SJS accounts for about half of the cases handled by the Taiwan Drug Relief Foundation. It is a rare and sometimes fatal skin disorder that often is caused by medication. SJS and its more severe form, toxic epidermal necrolysis (TEN), are characterized by painful blistering of the skin and skin lesions.

As the condition evolves and skin cells begin to die, skin can literally slough off. Treatment usually focuses on eliminating the underlying cause, if possible, and controlling the symptoms. Recovery can take several weeks to several months.

Chung’s research also appeared in Nature Medicine four years ago when he discovered a link between carbamazepine, an anti-seizure medicine, and patients with SJS. His discovery prompted the Taiwan Department of Health as well as the U.S. Food and Drug Administration to alert healthcare providers of the possible link and recommend genetic screening for the gene before prescribing the medication.

SOURCE: Stevens Johnson Syndrome › Chinese doctor’s discovery may lead to treatment for SJS

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

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