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Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to a May 18 FDA Drug Safety Communication.
The signal came from the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS), a cardiovascular safety trial for the drug that began in 2009. According to the safety alert, the independent data monitoring committee found in an interim analysis that leg and foot amputations occurred about twice as often in patients treated with canagliflozin than in those receiving placebo.
The agency is investigating the safety issue, but has yet to determine if taking canagliflozin is indeed associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013, the first in its class. It was soon followed by empagliflozin and dapagliflozin. The cardiovascular outcomes trial for empagliflozin (Jardiance), EMPA-REG, showed a 14% relative risk reduction for empagliflozin in the composite of cardiovascular death, MI, or stroke, compared with placebo, driven largely by a 38% relative risk reduction in cardiovascular death. This finding made SGLT-2 inhibitors the first glucose-lowering drug class that also prevents cardiovascular complications.
“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”
The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.
Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial (CANVAS); an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, CANVAS investigators determined that the risk of bone fracture is increased with canagliflozin treatment.
Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.
Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to a May 18 FDA Drug Safety Communication.
The signal came from the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS), a cardiovascular safety trial for the drug that began in 2009. According to the safety alert, the independent data monitoring committee found in an interim analysis that leg and foot amputations occurred about twice as often in patients treated with canagliflozin than in those receiving placebo.
The agency is investigating the safety issue, but has yet to determine if taking canagliflozin is indeed associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013, the first in its class. It was soon followed by empagliflozin and dapagliflozin. The cardiovascular outcomes trial for empagliflozin (Jardiance), EMPA-REG, showed a 14% relative risk reduction for empagliflozin in the composite of cardiovascular death, MI, or stroke, compared with placebo, driven largely by a 38% relative risk reduction in cardiovascular death. This finding made SGLT-2 inhibitors the first glucose-lowering drug class that also prevents cardiovascular complications.
“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”
The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.
Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial (CANVAS); an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, CANVAS investigators determined that the risk of bone fracture is increased with canagliflozin treatment.
Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.
Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to a May 18 FDA Drug Safety Communication.
The signal came from the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS), a cardiovascular safety trial for the drug that began in 2009. According to the safety alert, the independent data monitoring committee found in an interim analysis that leg and foot amputations occurred about twice as often in patients treated with canagliflozin than in those receiving placebo.
The agency is investigating the safety issue, but has yet to determine if taking canagliflozin is indeed associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013, the first in its class. It was soon followed by empagliflozin and dapagliflozin. The cardiovascular outcomes trial for empagliflozin (Jardiance), EMPA-REG, showed a 14% relative risk reduction for empagliflozin in the composite of cardiovascular death, MI, or stroke, compared with placebo, driven largely by a 38% relative risk reduction in cardiovascular death. This finding made SGLT-2 inhibitors the first glucose-lowering drug class that also prevents cardiovascular complications.
“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”
The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.
Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial (CANVAS); an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, CANVAS investigators determined that the risk of bone fracture is increased with canagliflozin treatment.
Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.
