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

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

“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