Data from the International Migraine Pain Assessment Clinical Trial (IMPACT) showed clinically significant improvement following treatment with Cambia in all four FDA-mandated co-primary endpoints for migraine – pain, nausea, potophobia and ponophobia.

“Our study demonstrates that diclofenac potassium for oral solution relieved the pain and reduced the other key migraine symptoms, quickly, effectively and safely,” said lead investigator Richard B. Lipton, M.D., professor and vice chairman of Neurology and professor of Epidemiology and Population Health at Albert Einstein College of Medicine in New York. “This unique formulation provides high rates of absorption, most likely accounting for the rapid onset of action,” added Lipton, who also directs the Montefiore Headache Center.

Cambia, made by Nautilus Neurosciences, is the only prescription non-steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine with or without aura. It carries the same health risks as other NSAIDS, including a rare but life-threatening hypersensitivity disorder known as Stevens Johnson Syndrome (SJS) and is most serious form, toxic epidermal necrolysis (TEN). SJS and TEN can be fatal. Patients who experience a rash while using Cambia should discontinue the medication immediately.

SOURCE: Stevens Johnson Syndrome › New migraine treatment to be available in US this month

VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets by AstraZeneca and POZEN, has been approved by the Food and Drug Administration (FDA) for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The medication is also designed to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated ulcers. The fixed dose of the pain-relieving non-steroidal anti-inflammatory (NSAID) drug combined with an immediate-release esomeprazole, a proton pump inhibitor, was shown in clinical studies to result in fewer endoscopic gastric ulcers compared to patients receiving enteric-coated naproxen.

The drug offers an alternative treatment to the estimated 27 million Americans are affected by osteoarthritis, which is the most common form of arthritis. While most sufferers treat their symptoms with NSAIDs, half of the chronic NSAID users are at risk of gastrointestinal ulcers.

However, VIMOVO is not without its side effects. Serious skin adverse reactions such as exfoliative dermatitis, SJS and the most severe form of SJS, toxic epidermal necrolysis (TEN), which can be fatal, can occur without warning. Patients taking VIMOVO should stop taking the medication at the first appearance of skin rash or any other sign of hypersensitivity.

Other, more commonly observed adverse events associated with VIMOVO include erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain and nausea.

SOURCE: Stevens Johnson Syndrome › New arthritis drug 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

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

Elizabeth had been diagnosed with toxic epidermal necrolysis (TEN), a severe form of Stevens Johnson Syndrome (SJS) in which the top layer of skin detaches from lower layers of skin all over the body. SJS and TEN is caused by severe reaction to certain drugs, such as nonsteroidal anti-inflammatory drugs (NSAID) and anticonvulsant medications. The incidence of TEN cases are reported as between 0.4 and 1.2 cases per million each year.

TENS generally affects the mucous membranes and is usually preceded by 1 to 2 weeks of fever. A rash forms and within hours the skin becomes painful and can easily be peeled away from the underlying dermis. The mouth can become blistered and eroded and the eyes can become blistered and ulcerated.

Elizabeth had been sent to Vanderbilt University Medical Center to “ride out” the illness. But as the disease progressed, she was put into a drug-induced coma to help shield her from the excruciating pain. She spent two weeks in the coma before she lost her battle to TEN. Her parents say they do not know what caused the severe epidermal reaction that led to her death, but say they are committed to helping educate other parents of the terrible reaction that killed their daughter.

SOURCE: Stevens Johnson Syndrome › Tennessee girl, 17, loses battle with TEN