Lilly Adds Warning to Strattera Label

[Guest guest]

" ........advising patients with jaundice or a liver injury to stop

taking the treatment.... "

Lilly Adds Warning to Strattera Label

© Reuters 2004.

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1103314220

NEW YORK (Reuters) - Eli Lilly and Co. on Friday said it added a

warning to the label of its attention deficit/hyperactivity disorder

medicine, advising patients with jaundice or a liver injury to stop

taking the treatment.

Lilly said the label change on the drug, known as Strattera,

discusses two reported cases of severe liver injury out of the more

than 2 million patients who have taken the medication since

approval.

Both patients have recovered with normal liver function after

discontinuing the medication.

The Indianapolis-based company said it is notifying physicians and

other health care providers about this label change.

Tim , analyst at Prudential Equity Group who lowered his

2005 earnings forecast for the company, said in a research note

Lilly's move is a " fairly severe label change " and that competitors

will use this label change against the product.

Lilly's shares fell $2.00, or 3.48 percent, to $55.40 during

afternoon trade on the New York Stock Exchange.

The American Stock Exchange's Pharmaceutical Index fell 4 percent,

pulled by Lilly's decline and a 14 percent drop in Pfizer Inc.'s

share price after a clinical trial showed increased risk of heart

attack for its arthritis drug, Celebrex.

Lilly said it reported the cases of liver injury to the Food and

Drug Administration and reviewed all available data on Strattera,

which indicated that the benefit-risk profile remains positive.

Attention deficit/hyperactivity disorder (ADHD) affects 3 percent to

5 percent of school age children, or about 2 million, the National

Institute of Mental Health said on its Web site. The principal

characteristics are inattention, hyperactivity and impulsiveness,

said the leading federal agency for researching mental and

behavioral disorders.

Strattera was given during clinical trials to 6,000 patients, who

experienced no sign of liver injury, Lilly said. Liver complications

are rare with medications, but they occur in a variety of

prescription and over-the-counter medicines, the company said.

Patients should contact their doctor if they develop pruritus (itchy

skin), jaundice, dark urine, upper right-sided abdominal tenderness,

or unexplained flu-like symptoms.

cut Strattera's sales forecasts by 25 percent, leading to

an earnings per share forecast cut to $3.00 from his prior estimate

of $3.06. His 2006 earnings per share forecast for Lilly was lowered

to $3.22 from $3.36.

http://www.reuters.com/newsArticle.jhtml?

type=businessNews & storyID=7128209

[Guest guest]

" ........advising patients with jaundice or a liver injury to stop

taking the treatment.... "

Lilly Adds Warning to Strattera Label

© Reuters 2004.

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1103314220

NEW YORK (Reuters) - Eli Lilly and Co. on Friday said it added a

warning to the label of its attention deficit/hyperactivity disorder

medicine, advising patients with jaundice or a liver injury to stop

taking the treatment.

Lilly said the label change on the drug, known as Strattera,

discusses two reported cases of severe liver injury out of the more

than 2 million patients who have taken the medication since

approval.

Both patients have recovered with normal liver function after

discontinuing the medication.

The Indianapolis-based company said it is notifying physicians and

other health care providers about this label change.

Tim , analyst at Prudential Equity Group who lowered his

2005 earnings forecast for the company, said in a research note

Lilly's move is a " fairly severe label change " and that competitors

will use this label change against the product.

Lilly's shares fell $2.00, or 3.48 percent, to $55.40 during

afternoon trade on the New York Stock Exchange.

The American Stock Exchange's Pharmaceutical Index fell 4 percent,

pulled by Lilly's decline and a 14 percent drop in Pfizer Inc.'s

share price after a clinical trial showed increased risk of heart

attack for its arthritis drug, Celebrex.

Lilly said it reported the cases of liver injury to the Food and

Drug Administration and reviewed all available data on Strattera,

which indicated that the benefit-risk profile remains positive.

Attention deficit/hyperactivity disorder (ADHD) affects 3 percent to

5 percent of school age children, or about 2 million, the National

Institute of Mental Health said on its Web site. The principal

characteristics are inattention, hyperactivity and impulsiveness,

said the leading federal agency for researching mental and

behavioral disorders.

Strattera was given during clinical trials to 6,000 patients, who

experienced no sign of liver injury, Lilly said. Liver complications

are rare with medications, but they occur in a variety of

prescription and over-the-counter medicines, the company said.

Patients should contact their doctor if they develop pruritus (itchy

skin), jaundice, dark urine, upper right-sided abdominal tenderness,

or unexplained flu-like symptoms.

cut Strattera's sales forecasts by 25 percent, leading to

an earnings per share forecast cut to $3.00 from his prior estimate

of $3.06. His 2006 earnings per share forecast for Lilly was lowered

to $3.22 from $3.36.

http://www.reuters.com/newsArticle.jhtml?

type=businessNews & storyID=7128209

[Guest guest]

" ........advising patients with jaundice or a liver injury to stop

taking the treatment.... "

Lilly Adds Warning to Strattera Label

© Reuters 2004.

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1103314220

NEW YORK (Reuters) - Eli Lilly and Co. on Friday said it added a

warning to the label of its attention deficit/hyperactivity disorder

medicine, advising patients with jaundice or a liver injury to stop

taking the treatment.

Lilly said the label change on the drug, known as Strattera,

discusses two reported cases of severe liver injury out of the more

than 2 million patients who have taken the medication since

approval.

Both patients have recovered with normal liver function after

discontinuing the medication.

The Indianapolis-based company said it is notifying physicians and

other health care providers about this label change.

Tim , analyst at Prudential Equity Group who lowered his

2005 earnings forecast for the company, said in a research note

Lilly's move is a " fairly severe label change " and that competitors

will use this label change against the product.

Lilly's shares fell $2.00, or 3.48 percent, to $55.40 during

afternoon trade on the New York Stock Exchange.

The American Stock Exchange's Pharmaceutical Index fell 4 percent,

pulled by Lilly's decline and a 14 percent drop in Pfizer Inc.'s

share price after a clinical trial showed increased risk of heart

attack for its arthritis drug, Celebrex.

Lilly said it reported the cases of liver injury to the Food and

Drug Administration and reviewed all available data on Strattera,

which indicated that the benefit-risk profile remains positive.

Attention deficit/hyperactivity disorder (ADHD) affects 3 percent to

5 percent of school age children, or about 2 million, the National

Institute of Mental Health said on its Web site. The principal

characteristics are inattention, hyperactivity and impulsiveness,

said the leading federal agency for researching mental and

behavioral disorders.

Strattera was given during clinical trials to 6,000 patients, who

experienced no sign of liver injury, Lilly said. Liver complications

are rare with medications, but they occur in a variety of

prescription and over-the-counter medicines, the company said.

Patients should contact their doctor if they develop pruritus (itchy

skin), jaundice, dark urine, upper right-sided abdominal tenderness,

or unexplained flu-like symptoms.

cut Strattera's sales forecasts by 25 percent, leading to

an earnings per share forecast cut to $3.00 from his prior estimate

of $3.06. His 2006 earnings per share forecast for Lilly was lowered

to $3.22 from $3.36.

http://www.reuters.com/newsArticle.jhtml?

type=businessNews & storyID=7128209

[Guest guest]

" ........advising patients with jaundice or a liver injury to stop

taking the treatment.... "

Lilly Adds Warning to Strattera Label

© Reuters 2004.

http://www.network54.com/Forum/message?

forumid=281849 & messageid=1103314220

NEW YORK (Reuters) - Eli Lilly and Co. on Friday said it added a

warning to the label of its attention deficit/hyperactivity disorder

medicine, advising patients with jaundice or a liver injury to stop

taking the treatment.

Lilly said the label change on the drug, known as Strattera,

discusses two reported cases of severe liver injury out of the more

than 2 million patients who have taken the medication since

approval.

Both patients have recovered with normal liver function after

discontinuing the medication.

The Indianapolis-based company said it is notifying physicians and

other health care providers about this label change.

Tim , analyst at Prudential Equity Group who lowered his

2005 earnings forecast for the company, said in a research note

Lilly's move is a " fairly severe label change " and that competitors

will use this label change against the product.

Lilly's shares fell $2.00, or 3.48 percent, to $55.40 during

afternoon trade on the New York Stock Exchange.

The American Stock Exchange's Pharmaceutical Index fell 4 percent,

pulled by Lilly's decline and a 14 percent drop in Pfizer Inc.'s

share price after a clinical trial showed increased risk of heart

attack for its arthritis drug, Celebrex.

Lilly said it reported the cases of liver injury to the Food and

Drug Administration and reviewed all available data on Strattera,

which indicated that the benefit-risk profile remains positive.

Attention deficit/hyperactivity disorder (ADHD) affects 3 percent to

5 percent of school age children, or about 2 million, the National

Institute of Mental Health said on its Web site. The principal

characteristics are inattention, hyperactivity and impulsiveness,

said the leading federal agency for researching mental and

behavioral disorders.

Strattera was given during clinical trials to 6,000 patients, who

experienced no sign of liver injury, Lilly said. Liver complications

are rare with medications, but they occur in a variety of

prescription and over-the-counter medicines, the company said.

Patients should contact their doctor if they develop pruritus (itchy

skin), jaundice, dark urine, upper right-sided abdominal tenderness,

or unexplained flu-like symptoms.

cut Strattera's sales forecasts by 25 percent, leading to

an earnings per share forecast cut to $3.00 from his prior estimate

of $3.06. His 2006 earnings per share forecast for Lilly was lowered

to $3.22 from $3.36.

http://www.reuters.com/newsArticle.jhtml?

type=businessNews & storyID=7128209