Food and Drug Administration
A drug prescribed for male and female infertility and menstrual disorders could hold the key to a more effective treatment for alcoholism, according to a study by researchers at the UCSF-affiliated Ernest Gallo Clinic and Research Center.
According to the National Center for Health Statistics (NCHS), there were 11,647 new whooping cough cases diagnosed in 2003, which represents 4.0 cases per 100,000. Of these 11,647 cases, there were 18 deaths. The Centers for Disease Control (CDC) also reported that respiratory distress was among the Top Ten causes of mortality of children in 2002.
The Food and Drug Administration (FDA) has announced the tentative approval of a co-packaged antiretroviral drug regimen manufactured by Aspen Pharmacare of South Africa for the treatment of HIV-1 infection in adults. The agency's tentative approval means that although existing patents and/or exclusivity prevent U.S. marketing of Aspen's product, it meets FDA's quality, safety and efficacy standards for U.S. marketing. This action makes this product available for potential procurement by President Bush's Emergency Plan for AIDS Relief.
The Food and Drug Administration (FDA) today announced the approval of pegaptanib sodium injection (Macugen), a new therapy to slow vision loss in people with the eye disease neovascular (wet) age-related macular degeneration (AMD). Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist. "Macugen is among the first treatments to target the underlying biology of wet age-related macular degeneration," said Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration. "Macugen provides a needed addition to the treatment of patients with this disease."
MRI-guided ultrasound therapy is an effective way to treat women with uterine fibroids, improving their quality of life and avoiding hysterectomy, a new study shows. The study reviewed the use of MRI and the ExAblate 2000, a device that was recently approved by the Food and Drug Administration. About 25% of women have uterine fibroids with a substantial proportion of these experiencing symptoms.
HHS Secretary Tommy G. Thompson announced today that 17.2 million influenza vaccine doses have been shipped in the last six weeks to health providers serving high-priority groups as part of the program to reallocate the vaccine to those areas and people who need it most. The Secretary also said that the Food and Drug Administration (FDA) has nearly completed its examination of vaccines from foreign manufacturers.
The Food and Drug Administration tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the BMJ today. Dr David Graham, Associate Director in the FDA's Office of Drug Safety, said that the FDA was ''incapable of protecting America against another Vioxx.'' He also indicated that five other drugs currently on the market may be endangering patients.
Remember when Grandma used to say 'don't go out in the cold; you'll get sick'? It turns out that she was right for a small number of people who have a condition called familial cold autoinflammatory syndrome (FCAS), in which individuals are afflicted by rash, fever, joint pain and flu-like symptoms after exposure to cold conditions as mild as an air-conditioned room or fall breeze.
As the scientific community is seeking alternatives to antibiotic treatment, periodontal researchers found that photodynamic therapy is advantageous for suppressing anaerobic bacteria that lead to periodontal diseases. PDT involves two stages. In the first stage, a light-sensitive drug is applied. The second stage involves shining a light or laser directly on the area treated with the drug. When the light is combined with the drug, phototoxic reactions are induced which destroy bacterial cells. PDT was first approved by the Food and Drug Administration in 1999 to treat pre-cancerous skin lesions of the face or scalp.
The Food and Drug Administration has warned consumers not to purchase or to consume Actra-Rx or Yilishen, two products promoted and offered for sale on Web sites as ''dietary supplements'' for treating erectile dysfunction and enhancing sexual performance for men. These products in fact contain an active prescription drug ingredient. FDA has also issued an Import Alert instructing FDA field personnel to stop the importation of ''Actra-Rx'' and ''Yilishen.''
For many patients with advanced Parkinson's disease, deep brain stimulation can mean the difference between having difficulty walking and being able to run. Since its approval by the Food and Drug Administration in 1997, the treatment has been used by 20,000 patients with advanced Parkinson's disease or other movement disorders to help control their symptoms. Now, researchers have discovered that surgically implanting electrical stimulators on just one side of a patient's brain could help alleviate symptoms on both sides of the body, potentially cutting the surgery risk for some patients. The results are published in the October issue of the journal Motor Control.
The Food and Drug Administration has approved a partial artificial heart intended to keep people alive in the hospital while they are awaiting a heart transplant. The product is a pulsating bi-ventricular device that is implanted into the chest to replace the patient's left and right ventricles (the bottom half of the heart). The implanted device is sewn to the patient's remaining atria (the top half of the heart). Hospitalized patients are connected by tubes from the heart through their chest wall to a large power-generating console, which operates and monitors the device.
Examination of reports from the first two years after licensure of a new vaccine against pneumococcal infections indicates that the majority of adverse effects are minor, but that continued surveillance is warranted, according to a new study. The Food and Drug Administration licensed the 7-valent pneumococcal conjugate vaccine (PCV, trade name Prevnar) on February 17, 2000. The recommended vaccination series includes doses at ages 2, 4, 6, and 12 to 15 months, with catch-up doses through 9 years of age.
Researchers are testing a new procedure in which they can take a tiny piece of a person's mouth lining, grow it into a dollar-bill sized piece of tissue and graft that expanded piece into the donor's mouth to heal a wound. Dr. Stephen Feinberg is leading a team that is currently working with five patients to treat small mouth wounds with the grafts. These five patients are part of what is called a proof of concept study for the Food and Drug Administration.
Researchers are testing a new procedure in which they can take a tiny piece of a person's mouth lining, grow it into a dollar-bill sized piece of tissue and graft that expanded piece into the donor's mouth to heal a wound. Dr. Stephen Feinberg is leading a team that is currently working with five patients to treat small mouth wounds with the grafts. These five patients are part of what is called a proof of concept study for the Food and Drug Administration.
