Roche Releases Guidelines for Consumers on How to Avoid Counterfeit Tamiflu(R)
May 08 2006 - 1:30PM
PR Newswire (US)
NUTLEY, N.J., May 8 /PRNewswire/ -- In an effort to ensure patients
receive only authentic Tamiflu(R) (oseltamivir phosphate) antiviral
medication, Roche has released practical guidelines outlining a
number of steps consumers can take to protect themselves, along
with a compilation of information resources and web links. The new
recommendations can be viewed at http://www.tamiflu.com/. Tamiflu,
the leading prescription antiviral medication for prevention and
treatment of influenza, is the only oral antiviral that has shown
activity in vitro and in animal studies against the H5N1 strain of
the avian flu virus, which is spreading throughout regions of Asia,
the Middle East, Africa and Europe. "Consumers worldwide can be
assured that Roche is doing everything possible to protect the
integrity of Tamiflu, and indeed all its products," said George
Abercrombie, President and CEO, Hoffmann-La Roche Inc. "We take the
counterfeiting threat extremely seriously, and continually adapt
our procedures. Diminishing the threat, of course, requires active
cooperation of all parties involved -- regulatory and law
enforcement, manufacturers, distributors, retailers, and ultimately
consumers." Abercrombie added that by knowing what to look for,
consumers can play a valuable role in protecting themselves from
the risks posed by counterfeit drugs. The new guidelines from Roche
provide specific information and tools to help consumers avoid
purchasing counterfeit Tamiflu, identify valid product, and act
judiciously if suspicions arise. Recommendations include: * How to
Avoid Purchasing Counterfeit Drugs -- Consumers should use caution
when purchasing on the Internet, be wary of offers to sell
medications without a valid prescription, and only purchase from a
licensed pharmacy. * How to Identify Authentic Tamiflu vs.
"Copycats" -- Tamiflu comes in a white cardboard box, which
contains a single blister package with 10 capsules. Each capsule is
a distinctive yellow and light grey color, and printed with the
words "Roche 75mg". * Where to obtain information related to
counterfeiting -- Identifying licensed pharmacies, obtaining
counterfeit drug alerts, reporting suspicious product or retailers
to the proper authorities. Additional details, including product
photos, are included in the guidelines at http://www.tamiflu.com/
"FAQ/Resources" http://www.tamiflu.com/consumer_guidelines.asp. The
guidelines will also be distributed through additional channels,
such as professional and patient advocacy groups. Latest in Series
of Corporate Initiatives The consumer guidelines are the latest
element in Roche's corporate anti-counterfeiting initiative, which
includes Internet surveillance, communications protocols and
tracking systems. The tactics are designed to protect the integrity
of Tamiflu from criminal counterfeiting, particularly in light of
recent seizures of counterfeit shipments in the U.S. and abroad.
Roche actively works with both U.S. and global regulatory agencies
such as the U.S. Food & Drug Administration (FDA) and the
European Agency for the Evaluation of Medicinal Products (EMEA);
global health authorities such as the WHO; law enforcement agencies
such as the Interpol; and customs, policy and trade organizations
at local levels. "While many of the anti-counterfeit activities
cannot be disclosed for security reasons, Roche continues to
proactively protect the integrity of Tamiflu throughout the supply
chain by ensuring the product is distributed only through
legitimate channels," explained Abercrombie. Meanwhile, Roche
continues to work with governments and health authorities such as
the Centers for Disease Prevention and Control (CDC) and the World
Health Organization (WHO) to develop stockpiles and make sure
Tamiflu is available to those who need it. Roche has increased
annual production capacity for Tamiflu to 400 million treatment
courses. About Tamiflu Tamiflu, co-developed by Gilead Sciences,
Inc., based in Foster City, CA, is a systemic treatment for the
most common strains of influenza (types A and B). Tamiflu is
indicated for the treatment of uncomplicated influenza caused by
viruses types A and B in patients one year and older who have been
symptomatic for no more than two days. Tamiflu is also indicated
for the prophylaxis of influenza in patients one year and older. In
treatment studies in adult patients, the most frequently reported
adverse events (incidence >1%) were nausea and vomiting. Other
events reported numerically more frequently in patients taking
Tamiflu compared with placebo were bronchitis, insomnia and
vertigo. In treatment studies in patients one to 12 years old, the
most frequently reported adverse event (incidence >1%) was
vomiting. Other events reported more frequently in patients taking
Tamiflu compared with placebo included abdominal pain, epistaxis,
ear disorder and conjunctivitis. In prophylaxis studies in adult
patients, adverse events were similar to those seen in the
treatment studies. Events reported more frequently in patients
taking Tamiflu compared with placebo (incidence >1%) were
nausea, vomiting, diarrhea, abdominal pain, dizziness, headache and
insomnia. In a household prophylaxis trial that included patients
one to 12 years old, adverse events were consistent with those
observed in pediatric treatment studies, with GI events being the
most frequently observed. Treatment efficacy in subjects with
chronic cardiac and/or respiratory disease has not been
established. No difference in the incidence of complications was
observed between the treatment and placebo groups in this
population. Safety and efficacy of repeated treatment or
prophylaxis courses have not been studied. In post-marketing
experience, rare cases of anaphylaxis and serious skin reactions,
including toxic epidermal necrolysis, Stevens-Johnson syndrome and
erythema multiforme, have been reported with Tamiflu. Vaccination
is considered the first line of defense against influenza. Tamiflu
is available for the treatment of influenza in more than 80
countries worldwide. About Roche Hoffmann-La Roche Inc. (Roche),
based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of
the Roche Group, one of the world's leading research-oriented
healthcare groups with core businesses in pharmaceuticals and
diagnostics. For more than 100 years, the Roche Group has been
committed to developing innovative products and services that
address prevention, diagnosis and treatment of diseases, thus
enhancing people's health and quality of life. An employer of
choice, in 2005, Roche was named one of Fortune magazine's Best
Companies to Work For in America, one of the Top 20 Employers
(Science magazine), ranked as the No. 3 Best Company to Work For in
NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For
additional information about the U.S. pharmaceuticals business,
visit our websites: http://www.rocheusa.com/ or
http://www.roche.us/. DATASOURCE: Roche CONTACT: Terence Hurley, of
Roche, +1-973-562-2882, ; or Sue Preziotti, of Fleishman-Hillard,
+1-212-453-2144, , for Roche Web site: http://www.rocheusa.com/
http://www.roche.us/ http://www.tamiflu.com/
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