Manufacturer recalls prefilled Lunelle syringes. (Contraceptive Failure Risk).
All prefilled syringes of the monthly injectable contraceptive Lunelle are being voluntarily recalled by the manufacturer "due to a lack of assurance of full potency and possible risk of contraceptive failure," the Food and Drug Administration announced.
"A subpotent dose of Lunelle may not be effective in preventing pregnancy" the FDA said in a statement. The agency and the manufacturer, Pharmacia, are advising women who have been relying on Lunelle for contraception to seek the advice of their health care professional about using alternative methods of birth control and to use an additional barrier method "until beginning a new form of hormonal contraception."
The company is not aware of any pregnancies that have occurred as a result of this problem. The recall does not include Lunelle packaged in vials, Bryant Haskins, a Pharmacia spokesperson, said in an interview.
The majority of women who have been using Lunelle are affected by this recall because most receive Lunelle from prefilled syringes rather than vials. Moreover, there are not enough Lunelle vials to make up for the loss of the prefilled syringes, so women will have to switch to other birth control methods for now, he said.
An investigation into the problem is underway and until that has been completed, the company cannot speculate when Lunelle prefilled syringes will be back on the market, Mr. Haskins said.
The recall was triggered by a customer who reported that a Lunelle prefilled syringe "looked different." Once tested, it was found to be subpotent, he said.
Approved in 2000, Lunelle contains 25 mg of medroxyprogesterone acetate and 5 mg of estradiol cypionate. In the World Health Organization's phase III trials of this method, the failure rate was reported as 0.2%/100 women-years, based on about 11,000 women-months of use.
In the U.S. trial that led to the approval of Lunelle, none of the 750 women on Lunelle became pregnant during the 60-week study, compared with 1 of the 321 women on a triphasic OC.
For more information on the recall, health care professionals can call Pharmacia at 800-323-4204 or refer to www.lunelle.com. Patients can call the company's patient information line at 888-691-6813.
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|Publication:||Family Practice News|
|Date:||Dec 1, 2002|
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