Label Changes for Cymbalta |
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Eli Lilly and the FDA notified healthcare professionals of revision to the precautions /Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain.
Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease.
The FDA recommends that Cymbalta not taken or administered to patients with any hepatic/liver insufficiency.
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Other Drugs / Medical Cases of Interest
A class action has been filed against biopharmaceutical company CV Therapeutics, Inc. (Nasdaq: CVTX) and certain of its officers and directors by stockholders who purchased the company's common stock between May 14 and August 1, 2003.
A class action has been filed against Yale New Haven Hospitals for failing to provide healthcare services to Connecticut residents regardless of their ability to pay. The lawsuit alleges that Yale has an obligation to provide free or low cost healthcare services because it operates as a non-profit organization and is exempt from federal, state and local taxes. The parties have reached a settlement apparently valued at $5,850,000 in an action filed against the Insurance of America Agency, Inc., the National Business Association, Inc., the American National Insurance Company, Inc., and the American National Life Insurance Company of Texas on behalf of all persons (1) who obtained certificates of insurance from American National Life Insurance Company of Texas, Inc., or American National Insurance Company, that were the subject of a trust agreement in which those companies were the administrators for the National Business Association insurance program after October 12, 1996, or (2) who were over eighteen as of July 1, 2003, and were insured under certificates containing a co-pay and wellness benefit rider offered by American National Life Insurance Company of Texas when notices issued in their state of residence that the rider was to be deleted. Persons who have not received notification, but are eligible to take part in the action should contact class counsel as soon as possible. GlaxoSmithKline and the FDA notified physicians of changes to the pregnancy/precautions section of the prescribing information for Paxil and Paxil CR Controlled-Release Tablets. Glaxo's studies suggest Paxil may be more likely to be linked to birth defects than similar drugs. Several class actions have been filed against nutritional supplement manufacturer NBTY, Inc., (NYSE: NTY) and certain of its officers and directors by stockholders who purchased the company's common stock between April 22, 2004, and June 16, 2004. The actions claim that the defendants violated federal securities laws by issuing a series of material misrepresentations to the market over this time period, thereby artificially inflating the price of the company's securities. A class action has been filed against pharmaceutical company Biovail Corporation (NYSE: BVF) and certain of its officers and directors by stockholders who purchased the company's common stock between May 17, 2002, and October 30, 2003. The action claims that the defendants violated federal securities laws by issuing a series of material misrepresentations to the market over this time period, thereby artificially inflating the price of the company's securities.
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