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FDA issues new warning for ADHD drug.(Clinical Rounds)
The Food and Drug Administration has issued a new warning for atomoxetine HCI concerning the potential for severe liver injury. The drug, indicated for the treatment of attention-deficit hyperactivity disorder in adults and children, has been available since 2002.
Two cases of severe liver injury were reported in a teenager and an adult who had taken atomoxetine (Strattera) for several months. Both recovered normal liver function after discontinuing the medication. The actual number of liver injury cases is unknown due to possible underreporting.
The new labeling will state that severe liver injury may progress to liver failure, which can result in death or the need for an organ transplant. An insert also will give list signs and symptoms of liver problems. Atomoxetine should be discontinued in patients who ...
- Eli Lilly.(Update)
- Magazine article from: Medical Marketing & Media February 1, 2005 700+ words
Eli Lilly has added a bolded warning about severe liver injury for Strattera, its attention deficit/hyperactivity disorder drug. The change followed reports about two patients (a teenager...
- FDA warns that ADHD drug may cause severe liver injury.(Clinical...
- Magazine article from: Skin & Allergy News Franklin, Deeanna February 1, 2005 700+ words
...labeling will state that severe liver injury may progress to liver failure...the actual number of cases of liver injury is unknown, and atomoxetine...have laboratory evidence of liver injury. Eli Lilly & Co., manufacturer...
- FDA warns that ADHD drug may cause liver injury.(Rx)(Brief Article)
- Magazine article from: Internal Medicine News Franklin, Deeanna February 1, 2005 700+ words
...labeling will state that severe liver injury may progress to liver failure...the actual number of cases of liver injury is unknown, and atomoxetine...have laboratory evidence of liver injury. Eli Lilly & Co., manufacturer...
- Lilly adds liver warning to Strattera label.(Eli Lilly and Co.)
- Newspaper article from: Pharma Marketletter January 3, 2005 700+ words
The USA's Eli Lilly has added a safety warning, in bold...jaundice or laboratory evidence of liver injury. News of the label change, which...recently-reported cases of severe liver injury relating to treatment with Stattera...
- Eli Lilly and Co., Indianapolis, June 14 (DDMAC).(CFSAN and DDMAC PROMO...
- Newspaper article from: Warning Letter Bulletin July 1, 2005 700+ words
...use of the drug beyond the indicated patient population," while also "minimizing the serious risks" - such as, severe liver injury - associated with the drug; and it [the ad] failed to clearly mention that contraindications may occur in patients with...
- Prescribed drugs, supplements tied to liver injury: antimicrobials are the most...
- Magazine article from: Family Practice News Moon, Mary Ann December 1, 2008 700+ words
...attributing a case of acute liver injury to acute drug exposure...specific causes of acute liver injury, more cases of suspected drug-induced liver injury may be found to have...Pfizer Inc., and Eli Lilly & Co. He received...
- Eli Lilly And Company Medical Equipment Company Share Analysis Inspects The...
- Press release article from: M2 Presswire September 15, 2008 700+ words
...September 2008-Research and Markets: Eli Lilly And Company Medical Equipment Company...researchandmarkets.com/research/d07178/eli_lilly_and_comp) has announced the addition of the "Eli Lilly and Company Medical Equipment Company...
- Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of...
- Newspaper article from: Biotech Week January 28, 2009 700+ words
American pharmaceutical giant Eli Lilly and Company today agreed to plead guilty...States criminal prosecution of any kind. Eli Lilly will also pay up to $800 million in...see also Psychiatric Disorders). Eli Lilly agreed to enter a global resolution with...
