To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Docs Advised To Suspend Use Of Newer Norplant (levonorgestrel implants) Kits URL: http://www.pslgroup.com/dg/1DDA86.htm Doctor's Guide August 18, 2000
ST. DAVIDS, PA -- August 18 -- Wyeth-Ayerst Laboratories sent an advisory letter to Norplant® System (levonorgestrel implants) providers on Thursday, August 10, 2000 recommending that they discontinue insertion of Norplant from kits that were distributed beginning October 7, 1999. During standard quality assurance monitoring, a lower than expected release rate result for shelf life stability in one lot caused Wyeth-Ayerst to begin an investigation, which is ongoing.
Due to the unique nature of the Norplant insertion procedure, Wyeth-Ayerst has taken the extra precaution of recommending that physicians not insert Norplant from seven additional lots, which were made at the same time as the one in question. In total, these eight lots contained approximately 22,000 kits. At this time, it is unclear how many of these kits have not yet been inserted. Norplant kits distributed before October 7, 1999 have met testing specifications.
"There is no cause for alarm," said Carolyn Westhoff, MD, MSc, Professor of Obstetrics and Gynecology and Public Health at Columbia-Presbyterian Medical Center, New York. "Wyeth-Ayerst is rightly being very cautious to take this course of action."
In the August letter to health care providers, Wyeth-Ayerst reiterated that the product label describes a five-year cumulative pregnancy rate of 3.9 percent in clinical studies.
While, at this time, Wyeth-Ayerst does not believe that there is an incremental risk of pregnancy with these lots, the Company advised health care providers that during this period of additional testing, for patients in whom the avoidance of pregnancy is of great importance, use of a concurrent nonhormonal (barrier) method can be considered.
Women who began using Norplant after October 7, 1999 should consult the health care provider who inserted the system if they have any questions. Women can also call Wyeth-Ayerst Global Product Information at 1-800-934-5556.
The advisory letter discusses kits with expiration dates in the year 2004, which are lot numbers #3990729, #3990775, #3990776, #3993006, #3003127, #3003166, #3003544 and #3003355.
The NORPLANT SYSTEM is a reversible five-year contraceptive. Approximately 106,000 women in the U.S. are currently using the Norplant System-representing less than 1 percent of all contraceptive users. The most common side effects of Norplant are menstrual bleeding irregularities. These vary from woman to woman and diminish over time. Other commonly reported side effects include headache, nausea, nervousness, dizziness, and removal difficulties. Norplant System does not protect against HIV and other STDs.
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