Robert Temple, a top official in the FDA’s Center for Drug Evaluation and Research, said few doctors notify the agency about incidents from warfarin because its risks are already well known. “Research has shown that the number of reported adverse events for a drug peaks during its first few years on the market,” when doctors are most likely to file voluntary reports to regulators and drugmakers, company spokeswoman Emily Baier said. The German company also declined to comment about the deaths, but said the number of reports of bleeding with Pradaxa were within Boehringer’s expectations, given the incidence of bleeding seen in the drug’s largest study. federal lawsuits have been filed against Boehringer Ingelheim alleging harm from Pradaxa.īoehringer declined to comment on the lawsuits. Adverse event reports on Xarelto were not available.Ī case study published in March raised alarm in particular, showing an elderly Utah patient on Pradaxa developed a massive brain hemorrhage and died after a minor fall.Įuropean regulators have instructed Boehringer Ingelheim to add warnings about the bleeding risk to Pradaxa’s package insert. The nonprofit Institute for Safe Medication Practices estimated last month that 542 reports of deaths associated with Pradaxa were reported to the FDA in 2011, topping all other medicines, including warfarin, with 72 deaths. They say that real world use of Pradaxa and Xarelto, which do not require regular blood monitoring or frequent doctor follow-up, raises concerns ab out t he risk of stroke, serious bleeding and blood clots if not taken properly, particularly in patients with poor kidney function. Patients taking warfarin require close monitoring and regular blood tests as well as dietary and lifestyle changes.ĭoctors have less data and familiarity with Xarelto, which is still being rolled out.īut Jacobson and another dozen physicians interviewed by Reuters expressed similar concerns about both Pradaxa and Xarelto. The condition affects about 3 million Americans, causing blood to pool in a storage chamber of the heart, where it can clot and travel to the brain.īoth new drugs were designed to sidestep risks of warfarin, including brain hemorrhages and other dangerous bleeding, and become mainstays of a new therapeutic market worth at least $10 billion a year. Xarelto, a once daily pill that Johnson & Johnson developed with Bayer AG, was approved last November for atrial fibrillation. “The average patient doesn’t understand anything about the new drug, or what the risks are, or what other medicines he can or can’t take,” said Jacobson, citing interactions with common painkillers and other drugs that can alter Pradaxa blood levels. “The bad news is you can kill a patient as easily with the new drug as you could with the old drug” if it is not handled properly. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California. “The good news is you now have an alternative to warfarin,” said Dr. It was the first new oral treatment for that use since warfarin was introduced in the 1950s. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Some are proposing a more rigorous monitoring regimen for when they are used. cardiologists hesitant to prescribe them. NEW YORK, June 14 (Reuters) - For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.īut growing complaints of risks and deaths tied to the new crop of drugs have made some t op U.S.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |