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Sat, Feb-24-07, 08:14
FDA orders warning 'guides' for ADHD drugs
Updated 2/21/2007 9:28 PM ET
By Rita Rubin, USA TODAY
Pharmacists will soon begin handing out consumer-friendly "medication guides" about cardiovascular and psychiatric problems linked to widely prescribed attention deficit/hyperactivity disorder drugs, the Food and Drug Administration announced Wednesday.
Tom Laughren, director of the FDA's Division of Psychiatry Products, said makers of the 15 products approved to treat ADHD have 30 days to finalize the language in the medication guides. Meanwhile, drafts written by the FDA are posted online at www.fda.gov/cder/drug/ infopage/ADHD/default.htm.
About 3% to 7% of school-age children and about 4% of adults have attention disorders, the FDA says. In 2006, U.S. sales of ADHD drugs totaled about $3.5 billion, according to IMS Health, a health care information company.
Laughren said the new guides reflect changes ordered last May in the warnings section of the drugs' physician labeling. Two FDA advisory committees a year ago recommended adding information about new data on cardiovascular and psychiatric problems in children and teens who took the ADHD drugs.
From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 who had taken one of the medications, Laughren said. It's not clear whether the deaths were the result of the ADHD drugs or underlying cardiovascular problems, he said.
In addition, since 2000 the agency has received hundreds of reports of psychosis or manic behavior, particularly hallucinations, in patients who had no known risk factors, according to an agency memo given last year to one of the advisory committees.
Also, a pooled analysis of trials that compared an ADHD drug with a placebo found a higher rate of hallucinations, delusions and mania in patients who were given the medication, Laughren said, putting the risk for such problems at one in 1,000 patients.
"Despite this new warning language in the medication guides … we continue to view ADHD as an important illness that benefits from treatment," Laughren said.
In other news, the FDA announced a "black box" warning for an asthma drug and a letter alerting doctors to a fracture risk seen in women taking a diabetes drug:
•The FDA has asked Genentech to add a black-box warning — the strongest type — to the label of Xolair, which is used to treat patients with asthma related to allergies. The warning emphasizes that the drug may cause anaphylaxis, which could include trouble breathing, chest tightness, dizziness, fainting, itching, hives and swelling of the mouth and throat. The agency has also ordered a medication guide for Xolair.
•GlaxoSmithKline notified doctors that a study comparing its Avandia with metformin and glyburide in patients with recently diagnosed type II diabetes found a higher risk of fractures in female patients who took Avandia.
The FDA says doctors should consider fracture risk when deciding whether to treat women with Avandia.
Find this article at:
http://www.usatoday.com/news/health/2007-02-21-adhd-guides_x.htm
Updated 2/21/2007 9:28 PM ET
By Rita Rubin, USA TODAY
Pharmacists will soon begin handing out consumer-friendly "medication guides" about cardiovascular and psychiatric problems linked to widely prescribed attention deficit/hyperactivity disorder drugs, the Food and Drug Administration announced Wednesday.
Tom Laughren, director of the FDA's Division of Psychiatry Products, said makers of the 15 products approved to treat ADHD have 30 days to finalize the language in the medication guides. Meanwhile, drafts written by the FDA are posted online at www.fda.gov/cder/drug/ infopage/ADHD/default.htm.
About 3% to 7% of school-age children and about 4% of adults have attention disorders, the FDA says. In 2006, U.S. sales of ADHD drugs totaled about $3.5 billion, according to IMS Health, a health care information company.
Laughren said the new guides reflect changes ordered last May in the warnings section of the drugs' physician labeling. Two FDA advisory committees a year ago recommended adding information about new data on cardiovascular and psychiatric problems in children and teens who took the ADHD drugs.
From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 who had taken one of the medications, Laughren said. It's not clear whether the deaths were the result of the ADHD drugs or underlying cardiovascular problems, he said.
In addition, since 2000 the agency has received hundreds of reports of psychosis or manic behavior, particularly hallucinations, in patients who had no known risk factors, according to an agency memo given last year to one of the advisory committees.
Also, a pooled analysis of trials that compared an ADHD drug with a placebo found a higher rate of hallucinations, delusions and mania in patients who were given the medication, Laughren said, putting the risk for such problems at one in 1,000 patients.
"Despite this new warning language in the medication guides … we continue to view ADHD as an important illness that benefits from treatment," Laughren said.
In other news, the FDA announced a "black box" warning for an asthma drug and a letter alerting doctors to a fracture risk seen in women taking a diabetes drug:
•The FDA has asked Genentech to add a black-box warning — the strongest type — to the label of Xolair, which is used to treat patients with asthma related to allergies. The warning emphasizes that the drug may cause anaphylaxis, which could include trouble breathing, chest tightness, dizziness, fainting, itching, hives and swelling of the mouth and throat. The agency has also ordered a medication guide for Xolair.
•GlaxoSmithKline notified doctors that a study comparing its Avandia with metformin and glyburide in patients with recently diagnosed type II diabetes found a higher risk of fractures in female patients who took Avandia.
The FDA says doctors should consider fracture risk when deciding whether to treat women with Avandia.
Find this article at:
http://www.usatoday.com/news/health/2007-02-21-adhd-guides_x.htm