 MEDLaw
Legal Team Attorneys / Physician - Lawyers representing those
injured by Ketek in Ketek lawsuit litigation.
Reports State that Bronchitis Drug Ketek May Cause Liver Failure, Death
On
June 29, 2006, the U.S. Food and Drug Administration ordered the
makers of Ketek to put a stronger warning on the drug labels because
of its link to serious liver injury, liver failure and death. The
FDA
has
received reports of 12 cases of acute liver failure, including four
deaths, in patients treated with Ketek, according to an internal
agency memo. FDA safety evaluators also uncovered 23 other cases
where patients suffered serious liver injuries after receiving the
antibiotic, also called telithromycin.
When the internal memo was leaked to the public, French drug
manufacturer Sanofi Aventis confirmed on May 19 that it was in
discussion with the USDA about its antibiotic Ketek after the USDA
wanted a warning label put on the drug. The FDA had rejected the
drug in 2001 and 2003, asking for more safety information.
Ketek is most frequently
prescribed for patients with chronic bronchitis; acute
bacterial sinusitis; and community acquired pneumonia of mild to
moderate severity, including pneumonia caused by resistant strep
infections.
When the FDA approved Ketek in April 2004, the drug's labeling
included precautions about liver injury and possible worsening of
myasthenia gravis, as with other drugs in its class.
Sanofi Adventis is now revising the drug labeling to address
the new concerns about Ketek’s potentially fatal impact.
Ketek's new label will also note that there have been reports of
fatal worsening of the neuromuscular condition, myasthenia gravis.
The FDA knows of three reported deaths in myasthenia gravis patients
taking Ketek. These deaths occurred separately from the reported
liver problems.
The drug is the
first FDA-approved antibiotic of the ketolide class, and the FDA has
concluded that the drugs’ benefit to patients for the approved
indications outweighs its risk. Following an internal FDA memo
reporting that Ketek has been linked to 12 cases of liver failure
and 4 deaths, French drug manufacturer Sanofi-Aventis confirmed on
May 19 that it was in discussion with the USDA about its antibiotic
Ketek after the USDA wanted a warning label put on the drug.
Recently, Ketek drug trials on children were widely criticized, even
from a few members of Congress. The drug had only been approved to
treat mild to moderate respiratory infections in adults.
The FDA
has said that it could not determine how frequently Ketek was
associated with adverse events, and concluded that since the drug’s
benefits outweighs its risks, it should stay on the
market.
Patients on Ketek should be vigilant, and watch for these signs and
symptoms of liver failure: fatigue, malaise, loss of appetite,
nausea, yellow skin and dark-colored urine.
Our in-house legal team consists of a physician-attorney, five
registered nurses, 11 attorneys, and more than 30 staff-members.
As one of the nation's premier pharmaceutical liability law
firms, we represent consumers nationwide who have been
victimized by defective medications, including Ketek.* We have the
experience to protect your legal rights and to help you
obtain the compensation you deserve. If you or a loved one
have suffered serious side effects from the use of Ketek,
please contact
us for an immediate case evaluation.
Many law firms that advertise aggressively on the Internet are
actually client brokers who refer virtually all clients to
lawyers in other firms and other cities who do the actual work
of representing the client. Janet, Jenner & Suggs, LLC, is a
traditional law firm that actively represents all of our
clients. Robert
K. Jenner and Kenneth
Suggs, leaders of the pharmaceutical department within the
firm, will always be accessible to you. Mr. Jenner and Mr.
Suggs, nationally recognized advocates on behalf of victims of
defective pharmaceutical products, and their highly experienced
team, will always be ready to answer your questions.
KETEK LAWYERS / ATTORNEYS
If you or a loved one have suffered from the dangerous side effects
of the Ketek you should consider receiving a free legal evaluation
from an experienced injury lawyer. For a free evaluation of your
situation please complete the following form and a Ketek attorney will contact you promptly -- free of charge.
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