Abstract
A 1995 publication on serious adverse events in users of Norplant® implants submitted
to the Food and Drug Administration’s MedWatch Spontaneous Reporting System reported
14 hospitalizations for stroke in Norplant users. This number was higher than expected.
This is a report on the association of current use of Norplant implants with stroke
and myocardial infarction (MI) based on a pooled analysis of data from two population-based,
case-control studies conducted in the US. All data collection for these two studies
occurred after approval of Norplant implants for marketing in the US in December 1990.
The methods of the individual studies are detailed in prior publications.
Keywords
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References
Wysowski DK, Green L. Serious adverse events in Norplant implants users reported to the Food and Drug Administration’s MedWatch Spontaneous Reporting System. Obstet Gynecol 1995;85:538–42.
- Myocardial infarction in users of low-dose oral contraceptives.Obstet Gynecol. 1996; 88: 939-944
- Stroke in users of low-dose oral contraceptives.N Engl J Med. 1996; 335: 8-15
- Use of low-dose oral contraceptives and stroke in young women.Ann Intern Med. 1997; 127: 596-603
Article info
Publication history
Accepted:
March 27,
1998
Received in revised form:
March 16,
1998
Received:
February 20,
1998
Identification
Copyright
© 1998 Elsevier Science Inc. Published by Elsevier Inc. All rights reserved.
