Abbott Laboratories' Statement Regarding FDA'S DDMAC Letter on Norvir(R) (Ritonavir Capsules) Materials
11 Juin 2004 - 2:24AM
PR Newswire (US)
Abbott Laboratories' Statement Regarding FDA'S DDMAC Letter on
Norvir(R) (Ritonavir Capsules) Materials ABBOTT PARK, Ill., June 10
/PRNewswire-FirstCall/ -- Abbott has received a warning letter from
the United States Food and Drug Administration's Division of Drug
Marketing Advertising and Communications (DDMAC) outlining concerns
related to the website and other specified materials for Norvir(R)
(ritonavir capsules) Soft Gelatin capsules. FDA's letter addresses
two primary concerns. The first pertains to a cost comparison chart
describing the daily cost of common anti-retroviral therapies. FDA
raised concerns that this chart could be interpreted to imply that
Norvir can be used as monotherapy at a sub-therapeutic dose. Abbott
developed this chart to respond to concerns regarding Abbott's
re-pricing of Norvir and not to promote the use of Norvir as
monotherapy at a sub- therapeutic dose. Abbott will modify the
materials in accordance with FDA guidance to address these issues.
Second, FDA raised concerns about the presentation of risk
information in certain materials regarding Norvir. Abbott will work
with the FDA to ensure that all Norvir-related materials provide
appropriate balance of risk information. About Norvir(3) NORVIR is
indicated in combination with other antiretroviral agents for the
treatment of HIV infection. This indication is based on the results
from a study in patients with advanced HIV disease that showed a
reduction in both mortality and AIDS-defining clinical events for
patients who received NORVIR either alone or in combination with
other nucleoside analogues. Median duration of follow-up in this
study was 13.5 months. Safety Information NORVIR should not be
taken if you have had a serious allergic reaction to NORVIR or any
of its ingredients. Taking NORVIR with certain drugs could create
potential for serious side effects that could be life-threatening.
Do not use NORVIR with Cordarone(R), ergotamine, ergonovine,
methylergonovine, and dihydoergotamine such as Cafergot(R),
Migranal(R), and D.H.E. 45(R) as well as Halcion(R), Hismanal(R),
Orap(R), Propulsid(R), Quinidine, Rythmol(R), Seldane(R),
Tambocor(TM), Vascor(R) and Versed(R). Particular caution should be
used when taking Viagra(R), since the interaction with NORVIR may
result in an increase in Viagra-related side effects. Discuss all
medicines, including those without a prescription, and herbal
preparations (for example, St. John's wort) you are taking or plan
to take with your doctor or pharmacist. Pancreatitis and liver
problems, which may cause death, have been reported in patients
receiving NORVIR. Tell your doctor if you have or have had liver
disease such as hepatitis. Varying degrees of cross-resistance
among protease inhibitors have been observed. In patients taking
protease inhibitors, increased bleeding (in patients with
hemophilia) and diabetes/high blood sugar have occurred. Some
patients have reported allergic reactions ranging from mild to
severe. Changes in body fat have been seen in some patients
receiving protease inhibitors. Some patients receiving NORVIR have
had large increases in triglycerides and cholesterol. The most
commonly reported side effects of moderate severity are: feeling
weak or tired, nausea, vomiting, diarrhea, loss of appetite,
abdominal pain, changes in taste, tingling feeling or numbness in
hands or feet or around the lips, headache, and dizziness. NORVIR
does not cure HIV infection or AIDS and does not reduce the risk of
passing of HIV to others. The long-term effects of Norvir are
unknown. Norvir has not been shown to reduce the risk of
transmitting HIV to others through sexual contact or blood
contamination. For more information, including Norvir (ritonavir)
full prescribing information, please visit http://www.norvir.com/ .
Abbott Laboratories is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs more than 70,000
people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com/ . DATASOURCE: Abbott
Laboratories CONTACT: Media, Melissa Brotz, +1-847-935-3456,
cellular, +1-847-772-2761, Jennifer Smoter, +1-847-935-8865,
cellular, +1-847-772-4631, or Financial Community, John Thomas,
+1-847-938-2655, all of Abbott Laboratories Web site:
http://www.norvir.com/ http://www.abbott.com/ Company News On-Call:
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