Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Friday August 1, 1997 - 2:13 PM EDT
"DuPont Merck has consistently maintained that our concerns with a generic warfarin, a blood-thinner, rest not with economics but with Barr's apparent lack of sensitivity to the patient safety issues associated with this narrow therapeutic index drug," says Nick Teti, president of DuPont Merck's pharmaceuticals division.
"Today, we are relating these concerns to the Food and Drug Administration (FDA) and are requesting that proper action be taken to protect the almost 3 million elderly Americans whose quality of life depends on warfarin therapy," he said.
Specifically, the manufacturer of Coumadin(R) (Warfarin Sodium Tablets, USP) Crystalline charged that Barr's educational materials contain incorrect, misleading indications and recommend therapeutic levels of warfarin in the blood that are higher than FDA-approved labeling and which, if followed by physicians, could result in severe bleeding.
DuPont Merck also criticized Barr for opposing state regulations and laws which would ensure physician and patient acceptance of warfarin substitution in spite of the fact that both DuPont Merck's and Barr's package labeling recommends additional blood monitoring when switching occurs.
A Barr official was quoted this week in the media mocking physician involvement as being "a permission slip like you'd get in grammar school," Teti said. "Clearly, we take physician prescribing of this critical medication far more seriously."
Sections of Barr's promotional materials DuPont Merck challenged include:
* One section indicates usage of Barr's warfarin as "effective for primary prophylaxis in cerebrovascular diseases and cardiovascular disorders known to carry a moderate to high risk of venous thrombosis." The FDA has not approved warfarin for primary prevention of cerebrovascular diseases, and the primary risk associated with cardiac disorder is not venous thrombosis but is often thromboembolic stroke.
* Another section recommends warfarin dosage for prosthetic heart valves, for example, to achieve an INR (a blood coagulation monitoring measure) of 3.0 to 4.5. FDA approved labeling recommends an INR of 2.5 - to 3.5 with a cautionary statement that an INR of greater than 4.0 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding.
"Both of these are serious clinical errors in interpreting appropriate use of warfarin," says Dr. David Grandison, vice president of Medical Affairs for DuPont Merck.
Additionally, Barr educational pieces do not contain fair balance -- that is, they fail to present an equal representation between therapeutic effectiveness and risk of adverse events.
DuPont Merck has been making Coumadin(R) for 42 years, primarily for elderly Americans over 60 years old. Average cost of therapy to patients is only 60 cents per day. The company provides valuable patient education and compliance materials, continuing medical education for physicians, and patient-management programs to help healthcare professionals better treat and monitor patients who are using the narrow therapeutic index drug.
DuPont Merck, a worldwide, research-based pharmaceutical company, is a partnership between DuPont (NYSE:DD - news) and Merck & Co., Inc. (NYSE:MRK). It is focused on research, development, and delivery of pharmaceuticals to treat unmet medical needs in the fight against central nervous system disorders, heart disease, cancer, HIV, and arthritis-related disorders. The company is also a leader in radiopharmaceuticals.
SOURCE: Dupont Merck Pharmaceutical Company
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