| September
10, 2007
UPDATE 2-Possible carcinogen found in Pfizer
AIDS drug
By Lisa Richwine
WASHINGTON, Sept 10 (Reuters) - A potential human carcinogen
has been found in batches of Pfizer Inc's (PFE.N: Quote, Profile,
Research) AIDS drug, Viracept, U.S. officials and the drugmaker
said on Monday.
Pregnant women and children who are starting HIV therapy should
not be given the drug until further notice, Pfizer and the Food
and Drug Administration said.
Tests detected the presence of ethyl methanesulfonate, or EMS,
a chemical formed during manufacturing, Pfizer said in a statement.
EMS is a "potential human carcinogen," the FDA and
Pfizer said.
Studies suggest EMS may cause cancer and birth defects in animals,
but no data for humans exist.
EMS levels were "substantially lower" than those that
prompted Roche Holding AG (ROG.VX: Quote, Profile, Research) to
recall the same drug in Europe, Pfizer said.
Viracept, known generically as nelfinavir, belongs to a class
of AIDS drugs called protease inhibitors. It is a key part of
many drug cocktails used to suppress the HIV virus that causes
AIDS.
"Pfizer is working with the FDA to prospectively limit EMS
levels in Viracept, while still considering the immediate needs
of patients on therapy," a company statement said.
In a letter to doctors, Pfizer said manufacturing changes would
reduce EMS levels so the theoretical increased cancer risk for
adults over a lifetime would be less than 1 case per 100,000 people
exposed.
Pediatric patients who are stable on Viracept-containing regimens
may continue to be treated with the drug, the company said. Pregnant
women currently taking Viracept should be switched to an alternative
medicine until the manufacturing changes are made, Pfizer said.
For pregnant women with no alternative treatment options, "FDA
and Pfizer agree that the risk-benefit ratio remains favorable
for the continued use of Viracept," the letter said.
In August, authorities suspended Roche's license to market Viracept
in the European Union because of the EMS finding.
Pfizer shares fell 1.2 percent to close at $23.96 on the New
York Stock Exchange.
Source: www.reuters.com
Comments:
Viracept, (generic name: nelfinavir) is one of the protease
inhibitors and i s used as a key part of many drug cocktails
to suppress the HIV virus. Despite the strong connection,
Pfizer still maintains that children who are currently receiving
Viracept and are stable should continue taking it and pregnant
women should switch to an alternative. Although Viracpet
is being recalled from European market at this time, Pfizer
is going to “reduce” this potential carcinogen
from future batches. It is interesting to read that they
are not going to eliminate this component, but just ‘reduce’
and continue to sell the drug with modifications. This once
again proves that drug companies, do not want to spare even
small children or unborn fetuses from their business grip.
According to the executives of drug cartel, potential danger
of developing cancer is not significant enough to stop the
prescription of Viracept.
Dr. Rath has been fighting for more than a decade to expose
such dangerous practices of drug companies. Extensive research
conducted at his Research Institute shows that synergistic
action of specific natural nutrients can help manage infectious
diseases in a safe and effective way. You can read more
about this on www.drrathresearch.org
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