The recalled packages have placebo pills where pills containing the active ingredients should be, Allergan said in a press release. The 28-pill pack should have 24 pink pills with the hormones norethindrone acetate and ethinyl estradiol, followed by the 4 placebos. However, in the recalled packs, the placebos are the first pills in line. Taking placebos allow women to still experience period-like bleeding, and could result in unexpected pregnancy, the company said.
“The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order,” Allergan said. “If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.”
Missing just a single day’s worth of oral contraceptive may put women at an increased risk for pregnancy, and for birth control regimens to be effective, all the pills must be taken in the correct order, according to the company.
Affected products were distributed to healthcare providers across the U.S., and have been in circulation since August 2016. Allergen was alerted to the problem by a physician report, after which the company ordered the voluntary recall.
Customers are being notified of these issues by letter, and have been advised to contact their physicians if they have any of the recalled products in their possession to arrange for return.
Allergan says it is unaware of any unintended pregnancies to be linked to the problem, to date.
Source: The Washington Post