News Tagged ‘FDA

Mother offers sight for sore eyes

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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Taiwanese researchers pinpoint genetic marker for SJS

The serious adverse reaction to medication known as Stevens Johnson Syndrome, or SJS, is rare in the U.S. and most countries, occurring in about one person per million each year. However, doctors at Chang Gung Memorial Hospital in Taipei, Taiwan, have seen as many as 40 to 50 cases of SJS in only a year. “Sometimes we see two or three in a single week,” says Ghung Wen-Hung, a researcher at Chang Gung, who was quoted in the Taipei Times.

Researchers like Wen-Hung are asking why.

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New labeling for CLL, NHL drug includes TEN warning

The FDA has approved labeling for a drug to treat chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL), to include a warning of a rare but life-threatening reaction to medication known as toxic epidermal necrolysis, also known as TEN, according to MedScape Today. TEN is the most severe form of Stevens Johnson Syndrome, or SJS, a condition that affects the skin and mucus membranes. appear on the skin and blister over, causing the skin to peel off in sheets. More than 200 drugs are linked to SJS and TEN, the most common being ibuprofen, antibiotics and anti-seizure medicines. The reported incidence of SJS or TEN is about one case per million people per year.

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Consortium studies genetic markers, hopes to predict SJS

The International Serious Adverse Events Consortium (SAEC) is a global, nonprofit partnership between leading pharmaceutical companies, the FDA and academic institutions. It was organized just more than a year ago. Among its goals, the consortium hopes to identify genetic markers that predict which individuals are at risk for drug-related serious adverse reactions, also known as SAEs.

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Stimulant drug added to list of meds that can cause SJS/TEN

A stimulant-type drug recently was added to the list of medications that may cause Stevens Johnson Syndrome (SJS), a rare but life-threatening condition affecting the skin and mucus membranes, causing the skin to blister and peel away in sheets. MedPage Today reported that drug maker Cephalon has agreed to update the drug’s label to warn of the potential risk of SJS and other serious and hypersensitivity reactions.

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SJS Foundation established to give answers to those with SJS

It was bad enough that Jean McCrawley’s infant daughter Julie was diagnosed with , but two weeks after she was prescribed phenobarbatol to treat her seizures, she woke up with a swollen eyes and a high fever. Jean took her daughter to the doctor who discovered blisters forming on the little girl’s shoulders and mouth. He diagnosed her with chicken pox.

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.”

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Family appeals case against makers of Children’s Motrin

The mother of 11-year-old Sabrina Johnson was clearly agitated when last summer a jury found Johnson & Johnson and McNeil Laboratories not liable for her daughter’s strong adverse reaction to over-the-counter medicine that left her blind. To Sabrina’s mother Joan, who was quoted by ABC 7 Eyewitness News, the ruling sent a painful message: “It means that nobody cares that she has been blinded. It means that nobody cares that she was almost tortured to death. That’s got to matter to somebody. And no, you should not see children, or mothers watching their children die. You’ve got to look into some of these cases.”

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Risk factors may indicate serious skin reaction to lamotrigine

Children treated with lamotrigine for who have a medical history of skin reactions to medication, use multiple drug therapies including the drug valproate, and cannot be adequately control their seizures with medication may be at greater risk for adverse skin reactions, according to Peer View Media Bar.

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

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Chinese doctor’s discovery may lead to treatment for SJS

A Chinese dermatologist believes he may have found a human protein that can lead to treatment for the severe and progressive skin disease, Stevens-Johnson Syndrome (SJS), according to the Taipei Times.

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FDA warns of link between anti-epilepsy drugs and SJS

The U.S. Food and Drug Administration is investigating the possibility that phenytoin and fosphenytoin sodium increase the risk of serious skin reactions, such as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), according to FDA MedWatch. Phenytoin and fosphenytoin are used to control tonic-clonic (grand mal) and complex-partial seizures in .

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