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Dear Susan:
On Friday, March 9, 2007, we received the questionnaires and other materials you
sent via overnight mail regarding people you represent who believe they
experienced an adverse event while taking AmbienŽ. We sent those materials, via
Federal Express, to Laurie H. Polinsky, Associate General Counsel at
sanofi-aventis US. She has sent these materials to the US Pharmacovigilance
group of her company.
As you noted in your letter to me, it is the obligation of sanofi-aventis to
conduct post-marketing safety follow-up where appropriate and, in accordance
with the expectations expressed in your letter, the US Pharmacovigilance group
will undertake that effort. Accordingly, they will need to contact your clients
directly regarding their use of AmbienŽ.
Sanofi-aventis treats matters of patient health and safety with the highest
priority. Please notify your clients (for whom you have submitted information
regarding their use of AmbienŽ and alleged adverse events) that the US
Pharmacovigilance group of sanofi-aventis US will contact them in the near
future to obtain additional information, including medical records. Please ask
your clients to cooperate in this process.
Very truly yours,
John F. Kuckelman
John F. Kuckelman
Shook, Hardy & Bacon L.L.P.
2555 Grand Blvd.
Kansas City, Missouri 64108
Telephone: (816) 474-xxxx
Facsimile: (816)xxx-xxxx
E-mail: jxxxxxxxxxxx
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