Andrew
01-04-06, 11:52 AM
Deaths Among Attention-Deficit Drug Patients to Get U.S. Review
Jan. 3 (Bloomberg) -- Cases of sudden death, heart attacks and strokes in people taking drugs for attention-deficit disorder will be examined by U.S. regulators at a Feb. 9 meeting.
The Food and Drug Administration asked its standing committee of risk-management advisers to review reports of deaths and heart-related complications in children and adults using the medications, according to a posting on the agency's Web site. The posting doesn't mention which attention-deficit-disorder drugs are linked to the reports.
The meeting will be in Gaithersburg, Maryland. A panel of FDA advisers told the agency at a June 2005 meeting that Johnson & Johnson might need to clarify heart warnings for its Concerta attention-deficit disorder drug.
The medications are stimulants and have been known for decades to have the potential for throwing off the heart's regular rhythms, FDA officials said at the June meeting. The medicines are often prescribed by doctors who aren't psychiatrists and don't have a complete understanding of their risks, FDA officials said at the time.
The FDA asked its advisers to comment at the Feb. 9 meeting on how the heart risk of attention-deficit-disorder drugs may be studied. The few long-term studies of the drugs provided little information on heart risks, the agency said.
The same committee will discuss the FDA's actions on painkillers and risk-management programs for Roche Holding Ag's Accutane acne drug and generic versions of it, according to the agency's posting.
To contact the reporter on this story:
Kerry Dooley Young in Washington kdooley@bloomberg.net
Last Updated: January 3, 2006 17:34 EST
Source: http://www.bloomberg.com/apps/news?pid=10000103&sid=aNh0gCfcKadQ&refer=us#
Jan. 3 (Bloomberg) -- Cases of sudden death, heart attacks and strokes in people taking drugs for attention-deficit disorder will be examined by U.S. regulators at a Feb. 9 meeting.
The Food and Drug Administration asked its standing committee of risk-management advisers to review reports of deaths and heart-related complications in children and adults using the medications, according to a posting on the agency's Web site. The posting doesn't mention which attention-deficit-disorder drugs are linked to the reports.
The meeting will be in Gaithersburg, Maryland. A panel of FDA advisers told the agency at a June 2005 meeting that Johnson & Johnson might need to clarify heart warnings for its Concerta attention-deficit disorder drug.
The medications are stimulants and have been known for decades to have the potential for throwing off the heart's regular rhythms, FDA officials said at the June meeting. The medicines are often prescribed by doctors who aren't psychiatrists and don't have a complete understanding of their risks, FDA officials said at the time.
The FDA asked its advisers to comment at the Feb. 9 meeting on how the heart risk of attention-deficit-disorder drugs may be studied. The few long-term studies of the drugs provided little information on heart risks, the agency said.
The same committee will discuss the FDA's actions on painkillers and risk-management programs for Roche Holding Ag's Accutane acne drug and generic versions of it, according to the agency's posting.
To contact the reporter on this story:
Kerry Dooley Young in Washington kdooley@bloomberg.net
Last Updated: January 3, 2006 17:34 EST
Source: http://www.bloomberg.com/apps/news?pid=10000103&sid=aNh0gCfcKadQ&refer=us#