Health Highlights: March 16, 2007

FDA Approves Drug for Rare Blood DisorderIndonesia Reports Another Bird Flu VictimFDA Mulls Status of Copycat Biotech DrugsRep. Patrick Kennedy Reveals Addiction to Painkiller OxyContinHundreds of NYC Patients May Have Been Exposed to TBHigh Zinc Levels in Eyes Linked to AMD

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

FDA Approves Drug for Rare Blood Disorder

The U.S. Food and Drug Administration said Friday that it's approved a first-of-its-kind drug to treat a rare blood disorder called paroxysmal nocturnal hemoglobinuria (PNH), which can cause disability and premature death.

The newly approved drug, Soliris (eculizumab), is a new molecular entity that contains an ingredient not previously marketed in the United States.

"This product is important in that it offers a treatment other than blood transfusion that may help this small population of patients who are often very ill," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.

Soliris does not cure PNH, but treats the breakdown of red blood cells, the most common characteristic of the disease. Patients with PNH can suffer pain, fatigue, debilitating weakness, blood clots and strokes, heart disease and intestinal disease.

The FDA approval of the drug was partly based on a study of 87 patients that found that half showed stabilization of blood hemoglobin over 26 weeks. The study was conducted by the maker of Soliris, Alexion Pharmaceuticals, Inc. of Cheshire, Ct.

Studies showed that serious meningococcal infection was a risk for patients taking Soliris, so the FDA ordered a boxed warning on the drug's labeling and said that all patients must receive meningococcal vaccination prior to being given Soliris.


Indonesia Reports Another Bird Flu Victim

A 32-year-old man is the latest victim of bird flu in Indonesia, bringing that country's death toll to 65, the highest in the world, Agence France Presse reported.

The man died Wednesday in a Jakarta hospital. While officials said it's not clear how he was infected, they said he did keep a parrot at home. Most bird flu victims have had contact with sick or infected birds. The health ministry said there are no reports of other people with influenza-like illness in the man's neighborhood.

Also on Friday, the Southeast Asian nation of Laos announced its second human death from bird flu. The disease was confirmed in a woman who died earlier this month, AFP reported.

So far, the H5N1 bird flu virus has killed 169 people worldwide. Most of the victims were in Southeast Asia. Experts fear that H5N1 could mutate into a form that's easily transmitted between humans and cause a global pandemic.


FDA Mulls Status of Copycat Biotech Drugs

The status of copycat versions of expensive biotech drugs in the United States may be placed below that of generic versions of chemical drugs, FDA chief Dr. Andrew von Eschenbach told drug industry executives Thursday.

He said the copycats would be considered only "similar" to brand-name biotech drugs and that the copycat versions would not be interchangeable, or able to be substituted, with the brand name versions, the Associated Press reported.

In contrast, generic versions of traditional chemical drugs are identical to the brand name versions, which means they can be swapped or substituted for one another.

Biotech drugs, which are made from proteins taken from living cells, are generally more complex and expensive than chemical drugs, the AP reported. The FDA says it still lacks the legal and scientific frameworks to approve copycat biotech drugs.

"We recognize that the end point would be what could be best described as similarity. Similarity in the sense that when a doctor gives you the product ... it will achieve an effect that is similar to the effect that we expected from the innovative ... compound," von Eschenbach said at the annual meeting of the Pharmaceutical Research and Manufacturers of America.


Rep. Patrick Kennedy Reveals Addiction to Painkiller OxyContin

Months before he crashed his car outside the U.S. Capitol last year, Rep. Patrick Kennedy sought treatment for an addiction to the painkiller OxyContin, the Rhode Island Democrat told NBC-TV's Today show on Friday.

After the crash, Kennedy checked into the Mayo Clinic in May 2006. At that time, he said he had already been at the clinic the previous Christmas for treatment of an addiction to a pain medication. He did not specify OxyContin as the cause of the addiction, the Associated Press reported.

On the Today show, Kennedy said he felt great in his recovery and said he was determined not to let addiction "take its toll on me ever again."

He spent a month at the Mayo clinic after the crash. After his rehab, Kennedy pleaded guilty to driving under the influence of prescription drugs. He's currently promoting legislation that would require equal health insurance coverage for mental and physical illnesses, the AP reported.


Hundreds of NYC Patients May Have Been Exposed to TB

Hundreds of babies and adults in New York City may have been exposed to tuberculosis by an infected hospital worker who was diagnosed with active TB on Jan. 30, said city health officials.

The infected employee worked at St. Barnabas Hospital in the Bronx and the city's Department of Health and Mental Hygiene has identified about 700 patients and other people, including 238 infants, who may have been exposed to TB, the Associated Press reported.

So far, 571 of those people or their relatives have been contacted by phone and mail. Of the 122 adults and 138 infants checked so far, three adults have tested positive for TB exposure, but no one has developed active TB, St. Barnabas Hospital officials said.

The infected hospital employee worked in the maternity ward, neonatal intensive care unit, the well-baby nursery and the psychiatric ward, the AP reported.

The fact that so many newborns may have been exposed to TB is especially worrisome, city health officials said.

"Because their immune systems are not fully developed, newborns who are exposed to TB are at high risk of developing active TB," Dr. Sonal Munsiff, assistant commissioner for TB control in the city's health department, told the AP.


High Zinc Levels in Eyes Linked to AMD

A U.K. study finds that elevated levels of zinc in the eyes may play a role in the development of age-related macular degeneration (AMD), the leading cause of blindness among elderly people in the developed world, BBC News reported.

The study, led by London's Institute of Ophthalmology, found that the eyes of people with AMD have high levels of zinc in drusen, microscopic structures in the eye that are an early sign of AMD.

"Zinc had previously been shown to contribute to the formation of plaques in the brains of patients with Alzheimer's disease, so it was logical for us to test the idea that zinc might also contribute to the formation of plaque-like drusen in the eye as well," said researcher Dr. Imre Lengyel.

"AMD can be considered as the Alzheimer's disease of the eye, in that both involve the build-up of proteins and metals like zinc and copper into microscopic clumps," Lengyel said.

The study, published in the journal Experimental Eye Research, could help in efforts to find new treatments for AMD, BBC News reported.


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