The drug Humira (adalimumab) has been approved to treat adults with moderately to severely active Crohn's disease, the U.S. Food and Drug Administration said Tuesday.
Crohn's is an incurable chronic inflammatory disease of the intestines that causes diarrhea, cramping, abdominal pain and, in some case, abnormal connections (fistulas) leading from the intestine to the skin.
The FDA approval of Humira was based on the results of four clinical trials involving 1,478 Crohn's patients. The drug, made by Abbott Laboratories, reduces excessive levels of human tumor necrosis factor (TNF) alpha, which plays a role in abnormal immune and inflammatory responses in the body.
"Humira has been shown to reduce signs and symptoms, and to induce and maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy, and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade (infliximab) therapy," Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said in a statement.
Humira's labeling carries the FDA's strongest "black box" warning that the drug may cause serious, potentially fatal infections, including tuberculosis and sepsis, and a type of cancer called lymphoma. Other possible side effects include upper respiratory infections, nausea, and sinusitis.
One Billion Affected by Serious Neurological Disorders
About one billion people worldwide have life-threatening or debilitating neurological problems such as epilepsy, dementia, and brain injuries, according to a World Health Organization report released Tuesday.
The figure is much higher than previous estimates (about 450 million six years ago), said the report, which also noted that people in many parts of the world lack adequate treatment for these disorders, Agence France Presse reported.
About 6.8 million people die each year as a result of neurological disorders (that's 11.7 percent of total deaths), the WHO said.
Neurological disorders are associated with huge care costs. In Europe alone, neurological diseases cost about $183 million in 2004, AFP reported.
In 2005, about 40 million people worldwide had epilepsy and 24 million had Alzheimer's disease or some other form of dementia. It's expected that the number of people with dementia will increase to 44 million by 2030, the WHO said.
Study on How to Reduce Germs: Open a Window
Opening windows may offer a simple way to prevent the spread of tuberculosis and other airborne infections, suggests a study by researchers at Imperial College London in the U.K.
The researchers compared 70 rooms with natural ventilation and 12 rooms with mechanical ventilation at a hospital in Lima, Peru. Even when wind speeds were at their lowest, natural ventilation was more effective than mechanical ventilation at dispersing airborne germs, CBC News reported.
"Opening windows and doors maximizes natural ventilation so that the risk of airborne contagion is much lower than with costly, maintenance-requiring mechanical ventilation systems," the study authors wrote.
"Old-fashioned clinical areas with high ceilings and large windows provide greatest protection. Natural ventilation costs little and is maintenance free," the researchers noted.
The study was published Tuesday in the online issue of the Public Library of Science journal PLoS Medicine.
Simple Test Helps Determine Risk of Aggressive Prostate Cancer
A simple test that measures PSA density can help identify men at high risk of life-threatening prostate cancer, says a study by Oregon scientists.
PSA density compares levels of a cancer-related protein called prostate-specific antigen to the size of a man's prostate, the Associated Press reported.
This study of 511 men found that those with the highest PSA densities were much more likely to develop aggressive prostate cancer than men with the lowest PSA densities.
After two years, 23 percent of the men with the highest PSA densities had developed prostate cancer, compared with 4 percent of those with the lowest densities. After four years, the rates were 36 percent and 9 percent, respectively, the AP reported.
The study was recently presented at a cancer conference in Florida. If further studies confirm the validity of this test, it could help save lives and reduce the need for repeated prostate biopsies, the researchers said.
Japan Investigates Possible Tamiflu Link to Deaths
Japanese officials have launched an investigation after the most recent suicide by a person taking the anti-viral drug Tamiflu, considered a frontline defense against a potential pandemic of bird flu or other types of influenza.
The latest case involved a 14-year-old boy who jumped to his death from a condominium tower in the northern city of Sendai on Tuesday, Agence France Presse reported.
Earlier this month, a 14-year-old girl taking Tamiflu died after she leaped off a condominium building in Aichi prefecture.
The Japanese health ministry said Tuesday that it will investigate Tamiflu, AFP reported.
"The connection (between the drug and the deaths) has not been made clear, but if that's the case then we will have to study special measures," Health Minister Hakuo Yanagisawa told reporters.
As of November 2006, 54 people had died after taking Tamiflu. Of those, 16 were age 16 or younger, the Japanese health ministry said.
An investigation last year by the U.S. Food and Drug Administration concluded there was no evidence linking Tamiflu with the deaths in Japan, AFP reported.
Older Antipsychotic Drugs Increase Death Risk in Elderly: Study
Older antipsychotic drugs increase the risk of death in elderly people with dementia, says a study published Tuesday in the Canadian Medical Association Journal.
The study of more than 37,000 people aged 65 and older in the province of British Columbia who took antipsychotic drugs between January 1996 and December 2004 found that those who took older, conventional drugs were 32 percent more likely to die within six months than those who took newer, atypical drugs, CBC News reported.
Among those taking the older drugs, the death rate was 14.1 percent, compared with 9.6 percent among those taking the newer drugs.
In 2005, the U.S. Food and Drug Administration and Health Canada warned that the newer, atypical antipsychotic drugs increased the risk of death among older patients with dementia. The warning may have led some people to believe that older, conventional antipsychotic drugs were safer.
"Together with earlier findings, the results from our study strongly suggest that Health Canada and the FDA should include conventional antipsychotic medications in their public health advisories, which currently warn only of the increased risk of death associated with the use of atypical antipsychotic medications in elderly patients with dementia," the study authors wrote.
While the reasons for the increased risk of death aren't clear, the researchers said there is evidence to suggest that the drugs may heighten the potential for heart problems and may have an effect on blood pressure and swallowing, CBC News reported.