Potential Pregnancy Scare as FDA Recalls Birth Control Pill with Packaging Error

A packaging error of birth control pills may result in a baby boom for some women next spring. The Food and Drug Administration announced earlier this month that they had placed a nationwide recall on Mibelas 24 Fe, a popular birth control pill after a packaging error was discovered. 

Birth Control Pill Packaging Problems

The pills, manufactured by Lupin Pharmaceuticals, were reversed in their blister pack wallet during manufacturing. This happened when the blister packs were placed in their wallet holders upside down. The four placebo pills that round out most birth control pill packs were placed at the beginning of the pack, instead of at the end where they are typically found. 

The affected pills were found in lot L600518 with an expiration date of May 2018.

Placebo pills do not contain the hormones that prevent pregnancy.

This packaging error could cause unintended pregnancies for some individuals, according to the FDA, because patients would be on the placebo pills for 8 days- four pills from the last pack and the four pills from the beginning of the pack with the packaging error.

Lupin Pharmaceuticals is working with the FDA and is working to recover the packs of incorrectly packed pills that were distributed.

Birth Control Pill Packaging Blunder Could Mean Pregnancy, Health Problems for Some

There is no recorded evidence of estrogen-based birth control pills, like Mibelas 24 Fe, causing a problem with fetal development. Estrogen-based birth control can make early pregnancy symptoms more severe.These symptoms include nausea, bloating and fatigue.

But other kinds of birth control have been linked to pregnancy problems and serious health repercussions. This is because some birth control pills can be teratogenic, or damaging to a growing fetus. While many women take birth control pill while unknowingly pregnant, doing so can have serious- and possibly deadly- health implications if taken after the eight-week mark.

"Progesterone-based birth control has been linked to ectopic pregnancies," said Dr. Mona Alqulali, M.D., F.A.C.O.G., Ph.D.

Pairing the Birth Control Pill with Other Methods to Prevent Pregnancy

Alqulali is an OBGYN in Clinton and Bettendorf, Iowa, who counsels patients on their birth control options.

"The birth control pill is an effective method of pregnancy prevention when taken properly," Alqulali said.

Many birth control pills are over 99 percent effective when taken as directed- which means taking it at the same time each day, every day. Alqulali recommends that her patients pair their birth control pills with backup methods of birth control, like condoms.

"Pairing birth control pills with a secondary birth control method reduces the risk of becoming pregnant," Alqulali said.  

There are many birth control options on the market to fit individual patient needs. Intrauterine devices, known as IUDs, are popular options. IUDs are small t-shaped plastic devices inserted into the wall of the uterus. Some IUDs contain hormones like levonorgestrel or progestin and last three to six years. These hormones change the environment of the uterus, making it inhospitable to sperm, and preventing conception. Other hormone based offerings include vaginal rings, birth control patches and shots, like Depo-Provera.

Birth Control Options for Patients That Don’t Want to Take the Pill

For patients who do not want to take hormonal methods of birth control or cannot tolerate hormonal methods of birth control, there are non-hormonal options available. Some IUDs, like Paraguard, do not contain hormones and are wrapped in copper. The copper of the Paraguard is released slowly and acts like a spermicide. IUDs without hormones can last about 10 to 12 years.  

Other options for patients who do not want hormones, but want less permanent prevention include barrier methods, like condoms and sponges. These methods are only effective in preventing pregnancy if used each time a patient has sex.

Women who have taken birth control pills from the affected lot should notify their physician and return the product to the pharmacy or place of purchase.

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