Xolair Gets Black Box Warning

The asthma drug Xolair has a new "black box" warning about severe, potentially life-threatening allergic reaction (anaphylaxis).

In February, the FDA requested Xolair's maker, Genentech, to put the boxed warning on Xolair. Now, those warnings have been added to Xolair's packaging.

Black box warnings are the FDA's sternest warning for prescription drug labels.

The new warning notes reports of anaphylaxis in patients taking Xolair. Those reports include new users of Xolair and patients who have been taking the asthma drug for longer than one year, according to the FDA.

The FDA notes that due to the risk of anaphylaxis, Xolair should only be administered to patients under direct medical supervision by health care workers who are aware of Xolair's anaphylaxis risk, monitor patients taking Xolair, and are prepared to treat anaphylaxis.
Xolair is given by injection to patients who are at least 12 years old and have moderate-to-severe persistent allergic asthma that doesn't respond to inhaled corticosteroids.

Patients taking Xolair should be informed about their chances of developing anaphylaxis, note the FDA and Genentech.

The warning notes that signs and symptoms of anaphylaxis can include the following:

• Wheezing, shortness of breath, cough, chest tightness, trouble breathing
• Low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom
• Swelling of the throat or tongue, throat tightness, hoarse voice, trouble swallowing
• Flushing, itching, hives, or feeling warm Patients experiencing such symptoms should seek emergency medical care.

The FDA notes three cases of anaphylaxis among 3,507 patients taking Xolair in the drug's premarketing clinical trials.

The FDA also states that in a review of 124 case reports among some 57,300 patients who took Xolair from June 2003 to December 2006, the frequency of anaphylaxis attributed to Xolair was estimated to be at least 0.2% of treated patients.

Source: www.epsdrugstore.com

Mild Drug Offers Hope in Treating Severe Alzheimer's

A new study has discovered that a drug initially used to treat mild to moderate Alzheimer's disease improved the memory and global function of people with severe Alzheimer's disease, and was safe and effective.

The six-month study involved 343 people with severe Alzheimer's disease at clinics in the United States, Canada, France, the United Kingdom, and Australia. Half of the group received a daily dose of donepezil; the other half received placebo. Cognitive tests were performed throughout the study.

The study found cognitive function stabilized or improved in 63 percent of people taking donepezil compared to 39 percent of people taking placebo. Compared to the placebo group, those taking donepezil showed improvement in memory, language, attention, and recognizing one's name. The donepezil group also showed less of a decline in social interaction, skills needed to complete a jigsaw puzzle, and arranging sentences compared to the placebo group.

"The effectiveness of donepezil in preserving cognitive and global function in people wit
h severe Alzheimer's disease, as evidenced by this study and others, is encouraging," said study author Sandra Black, MD, Brill Professor of Neurology at Sunnybrook Health Sciences Centre, University of Toronto in Canada, and member of the American Academy of Neurology.

"People who progress to the severe stage of Alzheimer's disease have markedly diminished cognitive and global function, so preserving cognitive function is a worthwhile treatment goal because it may help to keep patients at home longer, something that patients and caregivers often desire and which delays the costs of nursing home care," said Black.

According to Black, the most common side effects reported in this study,diarrhea, insomnia, nausea, infection, and bladder problems, were mild to moderate and consistent with the known side effects of such drugs.

"Our findings provide further evidence that donepezil is safe, effective and benefits cognition and global function in people with severe Alzheimer's disease," she said. According to Black, the most common side effects reported in this study, diarrhea, insomnia, nausea, infection, and bladder problems, were mild to moderate and consistent with the known side effects of such drugs.

"Our findings provide further evidence that donepezil is safe, effective and benefits cognition and global function in people with severe Alzheimer's disease," she said.

Source: www.epsdrugstore.com