Cilest, a contraceptive manufactured by Johnson & Johnson, has been withdrawn from the market in 43 countries, including Poland. The decision to stop selling 32 million Cilest tablets was made because "one of the active ingredients in this contraceptive does not meet specifications," a spokeswoman for Johnson & Johnson said. She also ensured that there is no risk to the he alth of women using Cilest.
How do Cilest contraceptive pills work?
Cilest is an oral contraceptive that reduces the production of ovulation-related hormones through the action of ethinylestradiol and norgestimate, two hormonal substances similar to estrogen and progesterone. In addition, Cilest changes the properties of the cervical mucus and endometrium in such a way that it is unable to accept a fertilized egg. Cilest also makes the mucus secreted around the entrance to the uterus thick and sticky, preventing sperm leakage.
Cilest withdrawn from sale also in Poland
Johnson & Johnson has decided to recall 179 batches of Cilest tablets from wholesalers and pharmacies in 43 countries, including Poland. According to information provided on the Polish website of Johnson & Johnson, the company decided to withdraw Cilest "due to the finding that the release of the active ingredient of the product is slower than it is defined in the specification". The Main Pharmaceutical Inspector announced that the decision was made "due to the fact that the solubility parameter of the active substance Norgestimatum was found to be inconsistent with the quality specification" - probably it is a slower than expected release of this hormone contained in Cileast.
As a spokeswoman for Johnson & Johnson said, "the level of risk for patients is low due to the lack of influence of the defective ingredient on the safety and efficacy of the product." She added that the company intends to bring the tablets back to the market as soon as possible.
Which parties of Cilest were withdrawn?
The Main Pharmaceutical Inspector has announced that two batches of Cilest tablets have been withdrawn from the market:
- Cilest ( Norgestimatum + Ethinylestradiolum ) - tablets250 mcg + 35 mcg, 21 tablets, Lot Number: CBS0K00, Expiration Date: Jan. 31, 2015
- Cilest ( Norgestimatum + Ethinylestradiolum ) - tablets 250 mcg + 35 mcg, 63 tablets, lot number: CFS2J00, expiration date: April 30, 2015
What should women using Cilest do?
Although the manufacturer of Cilest assures that the incompatibility of the solubility of norgestimate with the specification is not of significant importance for the safety of women taking it, or for the effectiveness of the preparation, it is better to protect yourself additionally. - Complete the tablet-taking cycle, but use another method in addition, such as a condom or vaginal pessaries. You should also visit a doctor who will change Cilest to a different type of tablets - advises Dr. Barbara Grzechocińska, a gynecologist.