Allergan Birth Control Packs Recalled Because Placebo Pills Were Placed Out Of Order
The mistake places users at a higher risk for unintended pregnancies.
The Wall Street Journal:
Allergan Recalls Taytulla Birth-Control Packs After Pills Placed Out Of Order
Allergan PLC is recalling nearly 170,000 sample packs of its birth-control treatment Taytulla after placebo and active capsules were placed out of order, potentially raising the risk of an unintended pregnancy. The drugmaker said Tuesday the physician sample packs of Taytulla were designed to have 24 active birth control pills, followed by four placebo pills, taken daily over the course of 28 days. Allergan, which attributed the issue to a packing error, said the four inactive pills were incorrectly placed at the start of the package. The company said it recently learned of the issue from a physician report and launched a voluntary recall of 168,768 packs. (Hufford, 5/29)
Allergan Recalls Birth-Control Pill Packs With Out-Of-Order Placebos
The blister packs should have contained pink capsules with oral contraceptive hormones for the first 24 days, followed by four days of maroon capsules without hormones. Reversing the order of the pills could have gone unnoticed by women taking them. Missing even a few days of the hormones could lead to unintended pregnancy if taken at the wrong time over 28 days. In a statement, Allergan said it is notifying customers by recall letter. It also encouraged patients to contact their doctors. (Cooney, 5/29)
Birth Control Pill Recall: Taytulla Packaging Error Could Lead To Unintended Pregnancy
If you have a package of the recalled pills, which were distributed to health care providers, you should your their doctor and return the item, the news release said. If you have questions, please contact your doctor or call Allergan at 1-800-678-1605 from 8 a.m. to 8 p.m. ET Monday through Friday. (Ewing, 5/29)
In other news —
The Addyi Female Libido Pill Has Fewer Restrictions In Canada. Is The U.S. Next?
In a little noticed move, the company that sells the Addyi pill for female sexual dysfunction recently won regulatory approval in Canada, thanks to a follow-up study designed to address a nagging safety question. But while the endorsement may set the stage for a commercial revival in the U.S., where the drug has been a spectacular flop, it’s not clear the findings will put the safety concerns to rest. At issue is the extent to which women should drink alcohol while on the drug, since it must be taken every day to be effective. In fact, when it was first approved nearly three years ago by the U.S. Food and Drug Administration, the product labeling warned that alcohol and Addyi should not be taken together. But in approving Addyi, Health Canada decided only to place limits on that interaction. (Silverman, 5/29)