New Warning Ordered For All ADHD Drugs The Food and Drug Administration yesterday directed the manufacturers of drugs prescribed for attention-deficit hyperactivity disorder to alert patients and parents of the risks of mental and heart problems, including sudden death.
The directive went to makers of Ritalin, Adderall, Strattera and all other ADHD drugs.
Draft versions of the package inserts posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who had heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.
The alerts also mention a slightly increased risk of psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior. Yesterday's announcement came about a year after two panels of FDA advisers recommended that the drugs include such patient medication guides.
U.S. Stillbirth Rate Dips; Teens, Blacks at RiskThe number of stillborn children in the United States declined steadily between 1990 and 2003, a government study found, but teenagers, black women, unmarried mothers, and those carrying three or more fetuses have an elevated risk.
There are about 1 million fetal deaths each year in the United States, most happening when there is no chance of survival, the Centers for Disease Control and Prevention reported. Stillbirths are deaths that occur after 20 weeks of the standard 40-week gestation period.
There were slightly more than six stillbirths for every 1,000 pregnancies past 20 weeks in 2003, a drop of about 1.4 percent each year since 1990, the CDC study found.
Little is known about the causes of fetal death. Several factors may increase the risk, including smoking during pregnancy, obesity, uncontrolled high blood pressure, diabetes, infections and problems with the placenta, the researchers said.
Black women experienced 11.56 stillbirths for every 1,000 pregnancies, more than twice the 4.94 rate for white women. The rate was 6.09 for American Indians and 5.46 for Hispanics.
The biggest risk was for women carrying triplets or more, with a 22.31 rate. Teenagers under age 15 had 13.18 stillbirths for every 1,000 pregnancies, while women 45 and older had 14.83.
Overall, 47 percent of fetal deaths occurred in unmarried women, and the higher risk remained regardless of age.
Stronger Label Warnings Sought for Asthma Drug The government ordered stronger label warnings for an injected asthma medication because of reports that some patients taking the drug, marketed as Xolair, had suffered a delayed and potentially life-threatening reaction known as anaphylaxis.
A patient experiencing anaphylaxis might have trouble breathing, feel tightness in the chest, have swelling in the mouth and throat, suffer dizziness or feel faint, or have itching and hives.
The risk of anaphylaxis was known when Xolair, also called omalizumab, was approved as an asthma treatment in 2003. But the Food and Drug Administration ordered the drug manufacturer, Genentech, to strengthen the label warnings because of reports of patients having a delayed reaction of anaphylaxis or reacting to a subsequent dose even when they had no problems after a first dose.
-- From News Services