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GENERAL INFORMATION |
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Ketek and Liver Damage, Liver Failure |
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| Ketek, also known as telithromycin, is an antibiotic prescription drug used for the treatment mild-to-moderate pneumonia. More than five million prescriptions for Ketek have been written in the United States since its approval in 2004 when it was initially also approved to treat bronchitis sinusitis. In December 2006, Ketek lost Food and Drug Administration approval for the treatment of the respiratory illnesses after an expert advisory panel found the risks of liver damage outweighed the treatment benefits. |
| A Congressional panel is conducting an investigation into whether pharmaceutical company Sanofi-aventis knew of critical integrity problems in clinical trial data it submitted to the FDA on its antibiotic Ketek and whether the FDA conspired to approve Ketek despite knowing about false trial results. The House Energy and Commerce Oversight and Investigations Subcommittee will vote in February 2008 on whether to subpoena FDA criminal investigators and documents related to the potentially deadly Ketek. Sanofi-aventis's lead researcher on the largest Ketek clinical trial plead guilty to mail fraud in 2004. |
| On June 28,
2006, the Food and Drug Administration (FDA) warned
that Ketek could in rare circumstances cause serious
liver injury, liver failure and even death. "We
clearly now understand that there is risk of serious
liver injury with Ketek," said Dr. John Jenkins,
director of the FDA’s Office of New Drugs. |
| Fourteen
adult patients in the United States have suffered
liver failure after taking Ketek. At least
four of them have died; 23 others suffered
serious liver injury. Other antibiotics cause
liver failure, but Ketek seems to do so almost
four times as often, safety officials concluded
in a review. |
In addition to liver
problems, Ketek can cause blurred vision and
loss of consciousness. In patients with myasthenia
gravis, a rare neurological disorder, it can
cause death.
For months, according to press reports, the FDA has internally debated
how to address Ketek's risks. |
| On July 18, 2006,
The New York Times that Dr. David Graham,
part of the FDA’s drug safety office,
wrote in a message dated June 16, 2006, that
the agency’s approval of Ketek, an antibiotic
made by Sanofi-Aventis that is also known as
telithromycin, was a mistake. |
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| Lieff
Cabraser Heimann & Bernstein,
LLP represents persons injured
in vehicle accidents. Click
here to submit your case. |
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| Referring to reports of
negative, or adverse, drug reactions voluntarily
submitted to the agency, Dr. Graham wrote, "We
don’t really know if the drug works; no one
is claiming it works better than other, safer drugs;
and we're flying blind as far as safety goes, except
for our own A.D.R. data that suggests telithromycin
is uniquely more toxic than most other drugs." Dr.
Graham concluded that the agency should recommend
the drug’s "immediate withdrawal." |
| The law in most states
provides several personal injury claims for
persons who have been seriously injured by
prescription or over-the-counter drugs with
dangerous, undisclosed side effects. These
claims include strict liability for a defective
product, failure to warn, and negligence. |
| Damages sought against
drug manufacturers for side effects and injuries
include: |
- Physical pain and suffering, mental
anguish and physical impairment;
- Medical expenses associated with the
allegedly defective product; and
- Loss of earnings and/or earning capacity.
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| In the case of a patient
that dies, a wrongful death suit may be filed
by the family. |
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Our lawyers
have years of experience successfully representing clients
in personal injury cases. |
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There
is no charge or obligation for our review of your case. |
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In death
and serious injury cases, we are pleased to visit you where
you live, at no cost, to discuss your legal rights and answer
your questions. |
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We have
retained product safety and medical experts nationwide to
assist our clients with their claims. |
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| If you or a family member
have suffered acute liver failure or other injuries
due to Ketek, you may be eligible to file a claim. Please
click here to contact an attorney at Lieff Cabraser to
discuss your legal rights at no cost or obligation.
We will handle all inquiries with the strictest
confidentiality and sensitivity. Inquiries from
Canada and other nations are also welcome. |
| You are also welcome
to call us toll-free at 1-800-541-7358; Visitors
from Canada can call 415-956-1000. Please ask to
speak with lawyer Heather Foster. |
| Founded in 1972, Lieff Cabraser Heimann & Bernstein,
LLP is an over fifty attorney
law firm with offices in San Francisco, New York and Nashville. For the last five years,
the National Law Journal has recognized Lieff Cabraser
as one of the top 20 plaintiffs’ law firms in America. |
| For our personal injury cases, we bring a team of experienced
lawyers. Each client is assigned an individual lawyer. In addition, we have
on staff multiple nurses, legal assistants, scientific analysts and case
clerks to assist the attorneys. To learn more about our firm, click
here. |
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injury and wrongful
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About Lieff Cabraser: We have
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represented clients in personal injury, wrongful death and
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Among the cases our personal injury
attorneys are prosecuting are the Medtronic heart lead recall, the
AMO contact lens solution recall, the Peter Pan peanut butter recall, Guidant
pacemaker defects, SUV
rollover accidents, popcorn
workers lung injuries, and Ford
switch fires.
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| Copyright © 2008 Lieff Cabraser Heimann & Bernstein, LLP |
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