The US Federal Drug Administration has recalled a birth control brand that the manufacturer mixed up in their packages, resulting in probable unwanted pregnancies.
The manufacturer, Lupin Pharmaceuticals, accidentally placed their hormone and placebo pills of Mibelas 24 Fe in the wrong order, New York Daily News reports. The package consists of 24 active hormone pills containing estradiol, which prevents ovulation, and four placebo pills that women are supposed to take at the end of their birth control cycle to prevent unwanted pregnancies.
Though the hormone pills and the placebo pills are of different colors – the active ones are white, the placebos are brown – the FDA warns that users could still become confused with the mislabeled packets.
The pills involved were distributed nationwide. They either have the lot number “L600518” and an expiration date of May 2018, or there is a blank or blurred listing for those two things.
Taking the pills in the wrong order could have very serious consequences for users. The FDA announcement stated,
For patients in whom a pregnancy is contraindicated or in whom concomitant medications may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death.
Dr. Lauren Streicher, an associate professor of obstetrics and gynecology at the Feinberg School of Medicine at Northwestern University, said that the risk of unplanned pregnancies as a result is very real, according to Today.
Streicher said, “If you take these first four pills thinking that they are the real thing, you may be off the pill for eight days instead of four and that increases the likelihood of inadvertent pregnancy.” This is not like missing one pill in the middle or end of a user’s cycle, which does not elevate the risk, she added.
Those who are already in the middle of their cycle and are using these pills, but have not had sex, don’t have a higher risk. But Streicher warned that a back-up contraception method should be in place, like condoms, just in case.
For those who have already started the pack and have had sex, Streicher said, “Pray. And continue to take the rest of the pack and use back-up contraception for the remainder of the cycle, such as condoms. If they don’t get their period when they finish the pack, do a pregnancy test.”