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Sandoz Pharmaceuticals Corp. v. Gunderson10/21/2005
14 days after initiation of treatment.
Fifteen cases of stroke during Parlodel(r) ... therapy have been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated.
Many of these patients experiencing seizures and or strokes reported developing a constant and often progressively severe headache hours to days prior to the acute event. Some cases of strokes and seizures during therapy with Parlodel(r) . . . were also preceded by visual disturbances (blurred vision and transient cortical blindness). Four cases of acute myocardial infarction have been reported, including 3 cases receiving Parlodel(r) . . . for the prevention of physiologic lactation. The relationship of these adverse reactions to Parlodel(r) . . . administration is not certain. The use of Parlodel(r) . . . is not recommended for patients with uncontrolled hypertension or toxemia of pregnancy.
Although there is no conclusive evidence which demonstrates the interaction between Parlodel(r) . . . and other ergot alkaloids, the concomitant use of these medications is not recommended. Particular attention should be paid to patients who have recently received other drugs that can alter the blood pressure.
This warning was approved by the FDA in 1987. In conjunction with the then new warning, the FDA required Sandoz to send a "Dear Doctor" letter to obstetricians noting the changes and calling attention to the adverse reactions. The estate presented evidence tending to show that Sandoz attempted to undermine the heightened warning by failing to send the "Dear Doctor" letter to more than a small fraction of the doctors registered in the college of obstetricians and gynecologists.
Because of its concern that so few doctors had received the letter, in 1988 the FDA required Sandoz to send the letter again to a wider audience and decided to include consideration of Parlodel(r) as a lactation suppressant at a 1988 meeting of its Fertility and Maternal Health Drugs Advisory Committee. In the fall of that year the ERI study was published. Following its review of that study and the other available data, the advisory committee determined that the relatively minor discomfort and inconvenience of postpartum lactation did not justify the potentially serious risks associated with drug therapies, including Parlodel(r). The committee recommended that that condition be treated conservatively, as it traditionally had been, with breast binding and analgesics, and that the indications of all drugs for that purpose be withdrawn. The FDA adopted the committee's recommendation in 1989 and asked manufacturers to voluntarily withdraw their drugs' lactation-suppression indications. With the exception of Sandoz, all manufacturers complied with the FDA's request.
Sandoz, however, continued to market Parlodel(r) for the suppression of postpartum lactation. In a May 1990 "Dear Doctor" letter acknowledging the FDA's request, the company wrote, Sandoz considers this request [to voluntarily withdraw the PPL indication] inappropriate for the following reasons: The question of need is one that should be determined between an informed patient and her physician and not by a governmental agency.
There is strong disagreement with the conclusion that there is no need for a drug to prevent lactation in the postpartum period. Although not all women who elect not to breast feed may require therapy to prevent lactation, a significant number will benefit from such therapy.
As demonstrated in controlled trials, the use of Parlodel(r) therapy to prevent the engorgement and pain that occur in many women who elect not to breast feed is a more effective approach than
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