People who take an opioid medication for pain are at a higher risk for heart problems. Patients prescribed an opioid painkiller had a 64% higher risk of early death compared to patients given an another type of pain med, researchers reported in JAMA. Much of the increased risk was connected to difficulty breathing during sleep, as well as abnormal heartbeat and other cardiovascular complications. Some of the alternatives meds examined in the study were Neurontin (gabapentin), Lyrica (pregabalin) and Tegretol (carbamazepine), and some low doses of antidepressants. The authors concluded that long-acting opioids should be in favor of other meds, especially in people with existing cardiovascular issues or diabetes. Posted June 14, 2016. Via Healthday.
The FDA is strengthening existing warnings about kidney injury risk for a popular class of type 2 diabetes drugs. The medications, Invokana and Invokamet (canagliflozin), as well as Farxiga and Xigduo XR (dapagliflozin), belong to a relatively new class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Between March 2013 and October 2015, the agency said it received word of 101 cases of acute kidney injury associated with the meds. The FDA is advising doctors to monitor a patient’s kidney function prior starting and while on therapy, and avoid prescribing the drugs to patients who may be predisposed to kidney injury. Posted June 14, 2016. Via FDA.
The FDA is calling on drugmakers to conduct long-term bone quality studies for the development of new osteoporosis treatments. The agency says in its guidance that the nonclinical studies are needed to investigate whether long-term use of osteoporosis drugs results in poorer bone quality. Because the studies are not to be conducted in humans, the FDA says companies should conduct studies in 2 animal species. In addition, the FDA is advising drugmakers that are developing anabolic drugs for osteoporosis study whether they have the potential to cause cancer. The agency says previous studies have shown potential for bone tumor growth in mice and rats when given parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) drugs. Posted June 13, 2016. Via Regulatory Affairs Professionals Society.