Food regulators based in the U.S. have rejected widespread use of a certain blood clot-preventing drug.
The drug makers who produce Bayer AG and Johnson & Johnson's Xarelto asked the U.S. Food and Drug Administration (FDA) for approval to market the drugs as blood clot and stroke preventers in patients with acute coronary syndrome (ACS), Reuters reported. The drug manufacturers also believe the drugs can prevent clogs in heart stents.
ACS encompasses a number of conditions that reduced blood flow to the heart. The drugs in question are currently only approved for preventing blood clot and stroke in patients with a type of irregular heartbeat called atrial fibrillation.
An advisory panel to the FDA suggested that Xarelto should not be prescribed for the proposed purpose. The panel concluded clinical data from a J&J (who markets the drug along with Bayer) trial was not sufficient to show it could prevent heart problems in the patients, some data was also missing.
J&J filed for X arelto use in ACS in 2011but the FDA declined due to lost information. The company was able to produce some of the missing information but the proposal was still denied, leading to an appeal of the decision.
"Clinical data from a single J&J trial was not strong enough to justify approval to market Xarelto to prevent further heart problems, especially since some data was missing, the panel found," Reuters reported.
J&J's appeal was denied and the marketer submitted a new marketing application; the panel still found this insufficient.
Those taking the drug are urged to call their doctor right away if these symptoms occur: "Nosebleeds that happen often; Unusual bleeding from gums; Menstrual bleeding that is heavier than normal, or vaginal bleeding; Bleeding that is severe or that you cannot control; Red, pink, or brown urine; Bright red or black stools (looks like tar); Cough up blood or blood clots; Vomit blood or your vomit looks like 'coffee grounds'; Headaches, feeling dizzy or weak; Pain, swelling, or new drainage at wound sites," a news release reported.
