The disorder, which causes mental retardation, smaller brain size, delayed speech and other neurological problems, occurs in one of every 12,000 to 15,000 live births in the United States. Kuvan is the first drug approved to slow the effects of PKU.
The FDA approval was based on the results of four short-term (up to 30 weeks) clinical studies that included a total of 579 patients. Common adverse effects reported in the studies included headache, diarrhea, abdominal pain, upper respiratory tract infection and throat pain.
People with PKU aren't able to break down phenylalanine (Phe), an amino acid found in foods that contain proteins, such as meat, dairy and egg products. As a result, PKU patients can develop high blood levels of Phe, which are toxic to the brain.
Kuvan must be used in combination with a Phe-restricted diet, and patients on the drug must have blood levels of Phe checked frequently, the FDA said.
Many Incontinent Adults Suffer in Silence
One in four American adults will experience incontinence at some point in their lives, but fewer than half of those with the condition -- the inability to control urination or bowel movements -- will voluntarily disclose symptoms to a doctor, says a panel of experts convened by the U.S. National Institutes of Health.
Women are most likely to develop incontinence. Growing older, being overweight, and lack of exercise are among the risk factors for both women and men, the Associated Press reported.
The panel called for more research to find better ways to prevent incontinence and to ease the stigma so that more people with condition will seek help. The experts noted that there are a number of effective treatments, ranging from exercise to medications to surgery.
"We as a society need to get over our discomfort with this subject so that incontinence sufferers receive the compassion, acceptance and care they need, and our aging population can take steps to prevent incontinence in the future," said panel leader Dr. C. Seth Landefeld, chief of geriatrics at the University of California, San Francisco.
Regular physical activity and weight control can help prevent incontinence. The experts recommended that obstetricians should end routine use of episiotomy, an incision to enlarge the vaginal opening during childbirth, the AP reported.
U.S. House Committee Investigating Zetia Trial
The handling of a key clinical trial of the cholesterol-lowering drug Zetia by drug makers Merck and Schering-Plough is being investigated by a U.S. Congressional committee, The New York Times reported.
The House Committee on Energy and Commerce this week sent a letter to the two drug companies demanding more information about the Enhance trial. It was completed in April 2006, but results have yet to be released.
The letter requested that officials at Merck and Schering-Plough agree to discuss the matter with investigators and said the drug makers should retain important documents about the trial, The Times reported.
Independent experts consider the Enhance trial results as vital because they may answer lingering questions about Zetia's safety and about whether the drug's ability to reduce cholesterol has any real biologic benefit for patients.
Bush Again Vetoes Children's Health Insurance Legislation