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You’ve likely seen the commercials for Detrol. A woman is sitting in her doctor’s office and a woman-shaped figure similar to the ones seen on bathroom doors, is encouraging her to talk to her doctor about her frequent and sudden urges to go to the bathroom. The treatment has helped women find relief from overactive bladder.
The Food and Drug Administration (FDA) in partnership with OSI Pharmaceuticals Inc., and Genentech have issued a warning letter to healthcare professionals informing them of new safety information added to the WARNINGS AND PRECAUTIONS section of the cancer treatment drug Tarceva.
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.
A cancer treatment drug approved by the Food and Drug Administration (FDA) to treat chronic lymphocytic leukemia and non-Hodgkin’s lymphoma just last year has been linked to a serious adverse reaction known as Stevens Johnson Syndrome, or SJS, when used in conjunction with another medication.
The International Serious Adverse Event Consortium (SAEC) this week released its first data, offering health care professionals more insight into the genetic basis for two serious adverse drug events – Stevens Johnson Syndrome (SJS) and its most severe form, toxic epidermal necrolysis (TEN), according to Health News Digest.
Drug maker Tibotec, which specializes in innovative therapeutic and diagnostic solutions for infectious diseases such as HIV/AIDS, is seeking approval from the FDA for its latest HIV treatment, Intelence, based on data from its phase-three studies of the drug when used in combination with other antiretroviral agents, according to a press release from Hays Pharma, a global pharmaceutical and biotech staffing and recruitment business.
A prescription drug given to counter a side effect of radiation for head and neck cancer now carries a warning about possible serious adverse reactions to the medication known as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Ethyol (amifostine) was among 29 drugs listed in a Jan. 30th FDA MedWatch announcement of drug products with safety labeling changes to their boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package inserts and medication guides.
The FDA recently approved safety labeling revisions for darunavir tablets, also known as Prezista, to warn of adverse reactions including skin rashes and Stevens Johnson Syndrome (SJS), according to MedScape.
The FDA has approved a new treatment to reduce the risk of cancer returning in patients with gastrointestinal stomal tumors, a disease also known as GIST, however the medication has been linked to Stevens Johnson Syndrome, or SJS.
If you or a family member has suffered from the rare but life-threatening adverse reaction to medication known as Stevens Johnson Syndrome (SJS), or its most severe form, toxic epidermal necrolysis (TEN), you already may be aware of the value information available at the Stevens Johnson Syndrome Foundation site (www.sjssupport.org). Unless you study the site, you may not be away of all the resources available.
Helen Milne makes a good point.
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.”
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