FDA Drug Safety Podcast: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin

Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug information.

On May 13, 2014, FDA announced that in its ongoing review of the blood thinner Pradaxa (generic name dabigatran), FDA recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin (Coumadin, Jantoven and generics), for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal bleeding, myocardial infarction, and death. Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation.

The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, compared to warfarin. The study also found an increased risk of major gastrointestinal bleeding with the use of Pradaxa as compared to warfarin. The myocardial infarction risk was similar for the two drugs.

It is important to note that the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval.

As a result of our latest findings, FDA still considers Pradaxa to have a favorable benefit-to-risk profile and has made no changes to the current label or recommendations for use. Patients should not stop taking Pradaxa (or warfarin) without first talking to their health care professional. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death. Health care professionals should continue to follow the dosing recommendations in the Pradaxa drug label.

FDA continues to investigate the reasons for differences in major GI bleeding rates for Pradaxa and warfarin observed in the Mini-Sentinel and Medicare analyses.

Thank you for listening. A link to the full communication detailing specific information for healthcare professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. Please report side effects involving Pradaxa to FDA’s Medwatch program at www.fda.gov/medwatch.

If you have drug questions, you can reach us at druginfo@fda.hhs.gov. And follow us on Twitter@FDA_Drug_Info for up-to-the-minute important drug information.

FDA Drug Safety Podcast: FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose

Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug Information. Today’s topic: FDA warns of next-day impairment with sleep aid Lunesta (active ingredient eszopiclone) and lowers recommended dose.

On May 15, 2014, FDA issued a Drug Safety Communication warning that the insomnia drug Lunesta can cause next-day impairment of driving and other activities that require alertness. As a result, we have decreased the recommended starting dose of Lunesta to 1 mg at bedtime. Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them. 

A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose. Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. 

Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness. We caution patients taking a 3 mg dose against driving or engaging in other activities that require complete mental alertness the day after use. 

We have approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes.

We are continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and will update the public as new information becomes available. Health care professionals and patients can refer to our Sleep Disorder (Sedative-Hypnotic) Drug Information Web page to find updated information and access the latest labels for insomnia drugs.

Report adverse events involving Lunesta to FDA’s MedWatch program at www.fda.gov/medwatch.

Thank you for listening.  A link to the full communication detailing specific information for healthcare professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. 

And follow us on Twitter @FDA_Drug_Info for up-to-the-minute important drug information.