Pradaxa shelf life limited, warns manufacturer

Pharmacists and patients are being told to be mindful of the limited shelf life of the new anticoagulant, Pradaxa (dabigatran etexilate), manufactured by Boehringer Ingelheim Pharmaceuticals.

The 60-count bottles and blister packs of Pradaxa last patients 30 days. However, the package insert advises, once the bottles are opened, the capsules have only a 30-day usage life.

“Once the bottle is opened, the capsules should be used within 30 days. This data is supported by the results of an intended 30-day, in-use stability study,” said Ann Moses, manager of public relations for Boehringer Ingelheim Pharmaceuticals.

The limited shelf life could affect viability at pharmacies if the product is opened, as well as in the home if patients buy more than 1 bottle or blister pack at a time. The 30-day shelf life can also confuse patients, Sarah Spinler, cardiology specialist at the University of the Sciences in Philadelphia, Pa., told the American Society of Health-System Pharmacists’ News Center.

If patients have more than 1 bottle of Pradaxa at a time, they might not differentiate between the new and old containers. “Patients really shouldn’t open up the new bottle until the other one is gone,” Spinler said.

According to Spinler, pharmacists should advise patients to write the date they first opened the container on their Pradaxa bottles. Pharmacists can also provide patients with a sticker upon which to record the bottle’s beyond-use date.

Pharmacists should refrain from opening Pradaxa bottles, which starts the 30-day countdown on the capsules’ shelf life, Spinler said.

According to Boehringer Ingelheim, when the bottles and blister packs are unopened, the recommended shelf life is 24 months.