Warnings About ADHD Drug Strattera Sept 2005

[Retired]

Access Health Canada Advisory

Subject: Health Canada advises Canadians of new warning for STRATTERATM (atomoxetine hydrochloride)

TORONTO, Ontario - September 29, 2005 - Eli Lilly Canada Inc., following discussions with Health Canada is advising Canadians that Strattera™ (atomoxetine hydrochloride) will now carry a new warning. This new warning indicates that patients of all ages taking Strattera may experience behavioural and/or emotional changes that put them at increased risk of self harm.

The new warning for Strattera will appear in the information package received by patients and in the prescribing information available to health professionals.

Patients, their families and caregivers should note that a small number of patients taking Strattera may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of aggression, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self harm.

Should this happen to you, consult your doctor immediately. Do not discontinue your medication on your own. Treatment with Attention-Deficit/Hyperactivity Disorder (ADHD) medications is safest and most effective when the patient communicates well with the treating physician about how he or she is feeling.

Doctors are advised to carefully monitor patients of all ages for emotional or behavioural changes that may indicate potential for harm, including suicidal thoughts and the onset or worsening of agitation-type adverse events.

This advisory stems from a recent analysis of placebo-controlled studies with Strattera. The analysis showed that suicidal ideation was more frequently observed in clinical trials among children and adolescents treated with Strattera (5/1357 [0.37%]) compared to those treated with placebo (0/851).

Strattera is a selective norepinephrine reuptake inhibitor, indicated only for the treatment of Attention-Deficit Hyperactivity Disorder in children six years of age or older, adolescents and adults.

CUSTOMER AND HEALTHCARE PROFESSIONAL INQUIRIES:
Eli Lilly Canada's Customer Response Centre 1-888-545-5972 (8:00 a.m. to 6:00 p.m. ET)

MEDIA INQUIRIES, PLEASE CONTACT:
Stephanie Batcules
Eli Lilly Canada Inc.
(416) 693-3571

Strattera™ is a registered trademark of Eli Lilly and Company, used under license.

Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, Ontario M1N 2E8
Canada
Tel.: 1-888-545-5972
Fax: 1-888-898-2961

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel.: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

For other inquiries, please refer to contact information:
Bureau of Cardiology, Allergy and Neurological Sciences
E-mail: bcans_enquiries@hc-sc.gc.ca
Tel.: (613) 941-1499
Fax: (613) 941-1668

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

 

[Retired]

Access Health Canada Advisory

Subject: Health Canada advises Canadians of new warning for STRATTERATM (atomoxetine hydrochloride)

TORONTO, Ontario - September 29, 2005 - Eli Lilly Canada Inc., following discussions with Health Canada is advising Canadians that Strattera™ (atomoxetine hydrochloride) will now carry a new warning. This new warning indicates that patients of all ages taking Strattera may experience behavioural and/or emotional changes that put them at increased risk of self harm.

The new warning for Strattera will appear in the information package received by patients and in the prescribing information available to health professionals.

Patients, their families and caregivers should note that a small number of patients taking Strattera may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of aggression, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self harm.

Should this happen to you, consult your doctor immediately. Do not discontinue your medication on your own. Treatment with Attention-Deficit/Hyperactivity Disorder (ADHD) medications is safest and most effective when the patient communicates well with the treating physician about how he or she is feeling.

Doctors are advised to carefully monitor patients of all ages for emotional or behavioural changes that may indicate potential for harm, including suicidal thoughts and the onset or worsening of agitation-type adverse events.

This advisory stems from a recent analysis of placebo-controlled studies with Strattera. The analysis showed that suicidal ideation was more frequently observed in clinical trials among children and adolescents treated with Strattera (5/1357 [0.37%]) compared to those treated with placebo (0/851).

Strattera is a selective norepinephrine reuptake inhibitor, indicated only for the treatment of Attention-Deficit Hyperactivity Disorder in children six years of age or older, adolescents and adults.

CUSTOMER AND HEALTHCARE PROFESSIONAL INQUIRIES:
Eli Lilly Canada's Customer Response Centre 1-888-545-5972 (8:00 a.m. to 6:00 p.m. ET)

MEDIA INQUIRIES, PLEASE CONTACT:
Stephanie Batcules
Eli Lilly Canada Inc.
(416) 693-3571

Strattera™ is a registered trademark of Eli Lilly and Company, used under license.

Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, Ontario M1N 2E8
Canada
Tel.: 1-888-545-5972
Fax: 1-888-898-2961

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel.: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

For other inquiries, please refer to contact information:
Bureau of Cardiology, Allergy and Neurological Sciences
E-mail: bcans_enquiries@hc-sc.gc.ca
Tel.: (613) 941-1499
Fax: (613) 941-1668

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

 

[Retired]

FDA Warns About ADHD Drug Strattera

WASHINGTON -- The Food and Drug Administration warned doctors Thursday about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug used to treat attention deficit hyperactivity disorder.

Manufacturer Eli Lilly & Co. announced that a black-box warning will be added to the drug's label in the United States. Such a warning is the most serious that can be added to a medication's label, and similar warnings will be added to the drug's labels in other countries. The company said a study showed instances of suicidal thinking were rare.

In a statement, the FDA said it "is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed."

Eli Lilly said it provided the FDA results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, but survived, company and FDA officials said.

There was no evidence of increased suicidal thoughts in adults taking Strattera, which also goes by the generic name atomoxetine, the Indianapolis-based company said.

"The actual risk is very low," said Dr. Thomas Laughren, head of the FDA's psychiatric drug unit. Despite the warning, he said, "FDA still views Strattera as an effective drug."

At the FDA's request, Eli Lilly will publish a guide for doctors and pharmacists to give to people who are prescribed Strattera.

The warning is the result of a larger FDA review of psychiatric drugs and their possible association with suicide, the agency said. Old drug studies are being reviewed for occurrences of suicides and suicidal thoughts. Last year, the FDA ordered warnings on all antidepressants that they "increase the risk of suicidal thinking and behavior" in children who take them.

Strattera won praise from some doctors and parents when it became available because, unlike Ritalin, it is not a stimulant, a class of drug that can be addictive. But its chemical makeup is similar to certain antidepressants.

A review of other ADHD drugs is continuing, Laughren said.

About 3.4 million patients -- adults and children -- have been prescribed Strattera since it became available, with Lilly officials saying about 75 percent of those taking the medication are children.

Dr. Harold Koplewisz, a professor of child and adolescent psychiatry at the New York University School of Medicine, said that 19 percent of all teenagers have suicidal thoughts, making "suicidal thoughts in adolescents part of the normal experience."

"There are 2,400 adolescents thinking about suicide for every one that commits suicide," he said in an e-mail. "We are talking about a medication that may make some children and teenagers uncomfortable, which is very different than a lethal situation like a gun in a house."

Still, he said, all children and teens taking psychiatric medication should be monitored.

Attention deficit hyperactivity disorder affects as many as 7 percent of school-aged children and 4 percent of adults in the United States.

Strattera's worldwide sales have dropped lately, falling 31 percent to $123.5 million during this year's second quarter from a year earlier.

Lilly warned doctors in December to stop using Strattera in patients with jaundice or who show signs of liver problems, and it placed a warning on the label and in prescribing information after at least two patients on the medication developed liver problems.

The company said Thursday it believes the drug is safe.

"While suicidal thinking was uncommon in patients on the medication during clinical trials, it is important for parents to be aware it can occur, and to discuss any unusual symptoms with a physician, " said Alan Breier, Lilly's chief medical officer, in a statement. "Lilly continues to view Strattera as a safe and effective treatment option, and those doing well on the medication should be able to continue their treatment with confidence."

Associated Press reporter Ashley M. Heher in Indianapolis contributed to this report.

FDA: U.S. Food and Drug Administration

Eli Lilly & Co.: Lilly.com | Eli Lilly and Company

 

[Retired]

FDA Warns About ADHD Drug Strattera

WASHINGTON -- The Food and Drug Administration warned doctors Thursday about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug used to treat attention deficit hyperactivity disorder.

Manufacturer Eli Lilly & Co. announced that a black-box warning will be added to the drug's label in the United States. Such a warning is the most serious that can be added to a medication's label, and similar warnings will be added to the drug's labels in other countries. The company said a study showed instances of suicidal thinking were rare.

In a statement, the FDA said it "is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed."

Eli Lilly said it provided the FDA results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, but survived, company and FDA officials said.

There was no evidence of increased suicidal thoughts in adults taking Strattera, which also goes by the generic name atomoxetine, the Indianapolis-based company said.

"The actual risk is very low," said Dr. Thomas Laughren, head of the FDA's psychiatric drug unit. Despite the warning, he said, "FDA still views Strattera as an effective drug."

At the FDA's request, Eli Lilly will publish a guide for doctors and pharmacists to give to people who are prescribed Strattera.

The warning is the result of a larger FDA review of psychiatric drugs and their possible association with suicide, the agency said. Old drug studies are being reviewed for occurrences of suicides and suicidal thoughts. Last year, the FDA ordered warnings on all antidepressants that they "increase the risk of suicidal thinking and behavior" in children who take them.

Strattera won praise from some doctors and parents when it became available because, unlike Ritalin, it is not a stimulant, a class of drug that can be addictive. But its chemical makeup is similar to certain antidepressants.

A review of other ADHD drugs is continuing, Laughren said.

About 3.4 million patients -- adults and children -- have been prescribed Strattera since it became available, with Lilly officials saying about 75 percent of those taking the medication are children.

Dr. Harold Koplewisz, a professor of child and adolescent psychiatry at the New York University School of Medicine, said that 19 percent of all teenagers have suicidal thoughts, making "suicidal thoughts in adolescents part of the normal experience."

"There are 2,400 adolescents thinking about suicide for every one that commits suicide," he said in an e-mail. "We are talking about a medication that may make some children and teenagers uncomfortable, which is very different than a lethal situation like a gun in a house."

Still, he said, all children and teens taking psychiatric medication should be monitored.

Attention deficit hyperactivity disorder affects as many as 7 percent of school-aged children and 4 percent of adults in the United States.

Strattera's worldwide sales have dropped lately, falling 31 percent to $123.5 million during this year's second quarter from a year earlier.

Lilly warned doctors in December to stop using Strattera in patients with jaundice or who show signs of liver problems, and it placed a warning on the label and in prescribing information after at least two patients on the medication developed liver problems.

The company said Thursday it believes the drug is safe.

"While suicidal thinking was uncommon in patients on the medication during clinical trials, it is important for parents to be aware it can occur, and to discuss any unusual symptoms with a physician, " said Alan Breier, Lilly's chief medical officer, in a statement. "Lilly continues to view Strattera as a safe and effective treatment option, and those doing well on the medication should be able to continue their treatment with confidence."

Associated Press reporter Ashley M. Heher in Indianapolis contributed to this report.

FDA: U.S. Food and Drug Administration

Eli Lilly & Co.: Lilly.com | Eli Lilly and Company