Taytulla is an orally administered prescription birth control pill used to prevent pregnancy. It is indicated for use by females of reproductive age once a day at the same time every day.
Manufactured by pharmaceutical company Allergan, it is the first and only oral contraceptive available in a soft gel capsule form.
However, the FDA recently announced a voluntary recall of Taytulla in the United States market. The recall was initiated following a physician’s report that stated that four placebo capsules were placed out of order–specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
Due to this packaging error, the capsules that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. Allergan states on the packaging that the user must take one pink capsule daily, beginning on day one of her menstrual cycle. This should be done for 24 consecutive days, followed by one maroon capsule daily on days 25 through 28.
The FDA highlights that the reversing order may not be apparent to either new users or previous users of the contraceptive–increasing the likelihood of taking the capsules out of order.
Our Taytulla lawyers are currently investigating cases for users who became pregnant while taking this drug.
What Are The Serious Side Effects of Taytulla?
Due to a packaging error, Taytulla can cause users to become pregnant during a time period they should have been taking the active contraceptive. This can be grounds for a lawsuit against Taytulla with the help of an attorney.
Users are instructed to begin the regiment either on the first day of their menstrual period or on the first Sunday after the onset of their menstrual period. During the first cycle, the capsules should be taken in the order directed on the package: one pink capsule daily for 24 consecutive days followed by one maroon capsule daily on days 25 through 28.
Due to the packaging error that mismatched the placebo capsules with the contraceptive regimen, these directions as stated by Allergan may cause users to mistake the active contraception with the placebo–increasing the risk of unintended pregnancy during the time in which it should be preventing it.
Smoking While Taking Taytulla
Allergan further warns against usage for women who smoke, stating to “not use Taytulla if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from a heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.”
Other Reported Complications
In addition to unintended pregnancy due to a packaging error, Allergan reports several warnings and precautions for those taking Taytulla that users should document and discuss with a lawyer. These include:
- Thromboembolic disorders and other vascular problems
- Liver disease, impaired liver function, and liver tumors
- High blood pressure
- Gallbladder Disease
- Carbohydrate and lipid metabolic effects
- Bleeding irregularities
- Carcinoma of the breasts and cervix
Additional side effects include but are not limited to:
- Serious cardiovascular events and stroke
- Breast tenderness
Taytulla birth control tablets were approved by the FDA in 2016 under the Allergan Pharmaceutical Corporation.
The FDA granted approved the contraceptive based on the prevention of pregnancy, having cited clinical trials conducted under widely varying conditions. Additionally, adverse reaction rate trials were conducted and cited in the approval application.
However, a recent voluntary recall was issued following a packaging error that mismatched the active contraceptive capsules with placebo capsules. This created the possibility of unintended pregnancy in users who followed the usage instructions per the packaging–the opposite of the drug’s stated intent.
Do I Need a Taytulla Attorney?
Contact a Taytulla lawyer if you became pregnant while taking this drug as instructed. Recalls of the mismatched packages are ongoing, but patients who have taken the recommended daily dosages have been reported to have unintentionally become pregnant. Requests to launch class-action lawsuits against Allergan have already been filed for unintended pregnancies while taking this drug.