The Food and Drug Administration has determined that the
antibiotic telithromycin (Ketek) may be associated with serious liver injury
and liver failure, and has been linked to four deaths and one liver transplant.
The drug's maker, Sanofi-Aventis, has upgraded a caution in the drug's label on
the potential for liver injury to a bolded warning that serious hepatic injury
has been “observed during or immediately after treatment.” Injury has
progressed rapidly after just a few doses, according to the company.
Ketek has not received a black box warning, and both the FDA and
Sanofi say the drug's benefits outweigh its risks.
“We are advising both patients taking Ketek and their doctors to
be on the alert for signs and symptoms of liver problems,” Dr. Steven Galson,
director of the FDA's Center for Drug Evaluation and Research, said in a
prepared statement.
However, the drug maker has stopped enrollment in five pediatric
trials investigating use of Ketek in acute otitis media, community-acquired
pneumonia, and tonsillitis in children 6 months to 18 years old.
The new warning is based partly on an FDA analysis that found that
Ketek may be associated with 12 cases of liver failure and four deaths since
its approval in 2004. “We're engaged in ongoing discussions with the FDA
regarding a detailed medical evaluation of hepatic events reported in
connection with Ketek use,” confirmed Sanofi spokeswoman Melissa Feltmann, who
would not comment further.
Ketek is currently approved for use in adults to treat
community-acquired pneumonia, sinusitis, and acute exacerbation of chronic
bronchitis.
“We still believe that the benefit of Ketek outweighs any known
risks of the drug when used for its FDA-approved indications,” said Emmy Tsui,
another Sanofi spokeswoman.
Ms. Tsui said therapy will continue according to protocol in
children already enrolled in the five pediatric trials, but that Sanofi would
not enroll any new trial participants until it was certain that its development
program “remains consistent with the current thinking of the FDA regarding the
structure and design of antibiotic drug development in pediatrics.”
The Senate Finance Committee has been investigating Ketek's
approval, as well as a postmarketing safety study that was later found to be
fraudulent.
For several months, committee chairman Charles Grassley (R-Iowa),
has been complaining that he's been stonewalled by the FDA in his attempts to
meet with the agency's special agent who investigated the fraud. In mid-June,
he visited the Department of Health and Human Services headquarters to demand
such a meeting. Vince Ventimiglia, assistant secretary for legislation at HHS,
said the agency has a policy of prohibiting access to lower-level
investigators. Sen. Grassley, however, pointed out numerous instances of such
investigators talking to the legislative branch, said a spokeswoman for the
senator.
PERSONAL COMMENT
So, in this article Sanofi
is taking the responsibility for the anthibiotic Ketek, that they have put on
the market. The results have showen that this anthibiotic can make serious
liver injory, and the medical assotiation wanted to forbid it on the phama
market. Anyways, Sanofi had admitied the truth and said that they can prevent
the liver injory, which, in my opinion is a good corporate tool, telling the
truth in the public and take the responsibility about the problem. Ketek wasn`t
took off the market.
With telling the truth,
they are building an honest corporate relationship with their costumers, that
is really important for the trust of your consumers.
Anyways, that is not
enough, because, the cosnumers of Sanofi`s products can be scared of buying the
products in the future, so I think that, beside taking the responsibility and
being honest, a big company like Sanofi should present in public a proof about
preventing the liver injures, or maybe a plan that is going to be realised.
Simona Markovska
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