Posted by Joe Bloe on February 22, 2007, at 1:21:21
US FDA tells ADHD drugmakers to warn of risks
21 Feb 2007 22:53:19 GMT
Source: ReutersBy Susan Heavey
WASHINGTON, Feb 21 (Reuters) - Companies that make drugs to treat attention deficit hyperactivity disorder must take extra steps to alert patients to possible cardiovascular and psychiatric risks, U.S. health officials said on Wednesday.
The Food and Drug Administration (FDA) said it told the drugmakers to develop patient-friendly guides that explain the risks and to hand them out with the medications, which already carry label warnings about the risks.
"Despite this new warning language ... we continue to view ADHD as an important ailment that benefits from treatment from this class of medications," said Dr. Tom Laughren, head of the FDA's division of psychiatry products. "We consider these drugs quite safe."
Novartis AG <NVS.N> <NOVN.VX>, Eli Lilly and Co.<LLY.N>, Johnson & Johnson <JNJ.N>, and Shire Plc <SHP.L> all make ADHD drugs. Shire also makes an ADHD patch.
Novartis, Shire and several privately held manufacturers said they would work with the FDA to produce the patient information. Representatives of other drugmakers did not have immediate comment.
ADHD can make it difficult for patients to pay attention and can cause hyperactivity and impulsiveness. The FDA said people with ADHD may have low self-esteem, difficulty in school, and trouble relating to family and peers.
The risk of heart and psychiatric trouble in patients taking ADHD medications is not new.
FDA officials held two public meetings in early 2006 about concerns over the risks associated with the drugs after reports of sudden death, heart attack and stroke in patients with underlying heart problems who took them.
Another FDA review found that about one in 1,000 patients experienced drug-related psychiatric issues, such as hearing voices, becoming suspicious for no reason, or becoming manic.
The FDA was criticized last summer when, without a public announcement, it asked manufacturers to include the warning on their labels.
Some critics have challenged the agency for taking too long to notify the public about the risks, while others have said the warnings could lead some patients who might benefit from the drugs to stop taking them.
While doctors should already be aware of the risks, FDA's Laughren said the agency wanted patients to have easier to understand information that would help them provide details about past heart or mental concerns before taking the drugs. The guidelines would also encourage them to report side effects.
Companies have 30 days to comply with the FDA's request. A draft of the guide is posted on the FDA's Web site at http://www.fda.gov/cder/drug/infopage/ADHD/default.htm (Additional reporting by Lisa Richwine)
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