Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New Drug Approved for Rare Disease That Causes Sudden Swelling
A new drug to treat a rare but potentially life-threatening genetic disease called hereditary angioedema (HAE) has been approved by the U.S. Food and Drug Administration.
HAE, which affects 6,000 to 10,000 people in the U.S., is caused by insufficient amounts of a plasma protein called C1-esterase inhibitor. People with the disease can develop sudden swelling of the hands, feet, limbs, face, intestinal tract, or airway.
These attacks of swelling can occur on their own or be triggered by stress, infection or surgery. Without immediate treatment, swelling of the airway can be deadly.
The newly-approved drug for HAE is called Ruconest. It is designed to restore the normal level of C1-esterase inhibitor in a patient’s plasma in order to treat sudden attacks of swelling, the FDA said.
The approval is based on a study of 44 adults and teens with HAE whose swelling attacks were treated with Ruconest. Common side effects caused by the drug included headache, nausea and diarrhea.
The drug is made by Pharming Group NV of the Netherlands and will be distributed in the U.S. by Santarus Inc., a subsidiary of Salix Pharmaceuticals Inc.
——
CDC Lacks ‘Culture of Safety’: Director
Recent safety lapses at the U.S. Centers for Disease Control and Prevention — such as the mishandling of live anthrax and accidental contamination of specimens with a dangerous bird flu strain — show that the agency lacks a “culture of safety,” CDC Director Tom Frieden said Wednesday.
Meanwhile, the U.S. Food and Drug Administration delivered disturbing news of its own as Frieden concluded his testimony before Congress on the CDC incidents.
In addition to finding six forgotten vials of smallpox virus recently, more than 300 other sealed vials containing biological materials such as dengue, influenza, Q fever, ricksettsia and other possible unknown viruses were found in the same cold storage room on the U.S. National Institutes of Health campus.
A sweep of all cold storage facilities has been ordered, USA Today reported.
FDA officials noted that the other pathogens listed on the additional vials do not pose the same threat as smallpox, the newspaper said.
In his testimony, CDC Director Frieden said the anthrax incident at his agency “was completely unacceptable. It should never have happened,” USA Today reported.
“With the recent incidents, we recognize a pattern at CDC where we need to greatly improve the culture of safety,” Frieden told an oversight committee of the House Comittee on Energy and Commerce. “What we’re seeing is a pattern that we missed, and the pattern is an insufficient culture of safety.”
Frieden said he is personally in charge of efforts to improve safety, such as closing two labs involved in two recent high-profile errors, the appointment of a senior scientist to be the single official in charge of lab safety, and suspending the transfer of biologic specimens from all the CDC’s biosafety level 3 and 4 labs, USA Today reported.
However, U.S. Rep. Fred Upton, R-Mich., noted that many of the measures sound like remedies the CDC said it made two years ago after the committee investigated safety issues at a CDC lab complex.
“Why should we believe this time things will be different?” Upton asked, USA Today reported.
—–
Large Rise in West African Ebola Cases, Deaths: WHO
The number of Ebola cases and deaths in West Africa rose sharply in the past week, according to the World Health Organization.
The number of suspected, probable and conformed cases of the disease in Guinea, Liberia and Sierra Leone was 964 as of Saturday, a 14 percent increase from a week earlier, The New York Times reported.
The number of deaths as of Saturday was 603, about 16 percent higher than a week earlier, the WHO said. About half the deaths have been in Guinea.
“This trend indicates that a high level of transmission of the Ebola virus continues to take place in the community,” the WHO said in the update, The Times reported.
“The respective ministries of health are working with WHO and partners to step up outbreak containment measures,” the agency noted.
New agencies said that due to the outbreak, Ivory Coast border officials prevented hundreds of Ivorian refugees in Liberia from returning, The Times reported.
There is no known cure for Ebola, and the death rate among infected people is as high as 90 percent.
Copyright © 2024 HealthDay. All rights reserved.