Warning on NSAIDs; new schizophrenia drug approved

Recalls and warnings

A strengthened warning that NSAIDs increase the chance of heart attack or stroke. Based on a comprehensive review of new safety information, the FDA is requiring updates to the drug labels of all prescription NSAIDs and will also request updates to over-the-counter nonaspirin NSAID labels. Label revisions include information about the risk of heart attack or stroke occurring as early as the first weeks of using an NSAID and the risk appearing greater at higher doses.

A market withdrawal of 14 lots of calcium chloride intravenous infusion 10% w/v, packaged in 10-mL prefilled syringes by Mylan Institutional as a precautionary measure because of customer complaints citing difficulties administering it as a result of incompatibility between the syringe and needleless adaptors.

A Class I recall of Lifesaver single patient use manual resuscitator by Teleflex Hudson RCI. The oxygen intake port may be blocked, which can prevent the bag from filling. This can prevent the device from delivering breathing support, and a delay in treatment could lead to patient injury or death.

A Class I recall of FLOW-I Anesthesia Systems by Maquet. The firm has received 10 reports that this device has malfunctioned, and patient cassettes, which are the center of gas flow in the system, have come loose. This may cause anesthesia gas to leak and prevent the ventilator from providing breathing support if not corrected immediately. No injuries or deaths have been reported.

An alert on reports of patient deaths and other serious adverse events associated with use of the Lariat Suture Delivery Device and its associated devices to close the left atrial appendage (LAA) and prevent stroke in patients with atrial fibrillation. At least 45 adverse events, including 6 deaths, have occurred in patients undergoing procedures with these devices. Serious medical complications have included laceration and/or perforation of the heart, complete LAA detachment from the heart, hemorrhage, hypotension, pericardial effusion, cardiac tamponade, and pleural effusion. Of these 45 events, 34 resulted in the need to perform emergency heart surgery.

Approvals

Sacubitril/valsartan (Entresto) tablets for the treatment of heart failure. In a clinical trial of more than 8,000 patients, the drug was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to enalapril. Most patients were also receiving approved heart failure treatments, including beta-blockers and diuretics. The most common side effects were hypotension, hyperkalemia, and renal impairment. Angioedema was also reported on the drug, and black patients and those with a prior history of the allergic reaction have a higher risk of this side effect.

Brexpiprazole (Rexulti) tablets to treat schizophrenia and as an add-on treatment to an antidepressant to treat major depressive disorder. In 2 clinical trials of 1,310 participants, the drug was shown to reduce schizophrenia symptoms when compared to placebo. In 2 additional trials of 1,046 participants for whom an antidepressant alone did not adequately treat their symptoms, those taking the drug reported fewer symptoms of depression than those taking placebo. The most common side effects included weight gain and a sense of restlessness. Like other drugs used to treat schizophrenia, it carries a boxed warning about increased risk of death associated with the off-label use in dementia-related psychosis and increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.

Cangrelor (Kengreal), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries. The drug is approved for adults undergoing percutaneous coronary intervention, as it reduces the risk of serious clotting complications related to the procedure, including heart attack and stent thrombosis. As with other antiplatelet drugs, bleeding, including life-threatening bleeding, is the most serious risk. A large clinical trial comparing cangrelor to clopidogrel found that about 1 in 170 patients had a serious bleed, compared to about 1 in 275 clopidogrel patients.

The BrainPort V100, a new device to help the blind process visual signals through their tongues. The battery-powered device includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against his tongue. Software converts captured images into electrical signals, which are perceived as vibration or tingling on the user's tongue through the intra-oral device. Clinical studies showed that 69% of 74 subjects who completed 1 year of device training were successful at an object recognition test. No serious adverse events were reported, although some patients reported burning, stinging, or metallic taste associated with the intra-oral device.

Lumacaftor/ivacaftor (Orkambi) to treat cystic fibrosis. This is the first approved drug directed at treating the cause of the disease in patients 12 and older with 2 copies of the F508del mutation. In 2 clinical trials of 1,108 participants, those who took 2 pills every 12 hours demonstrated improved lung function compared to placebo. The most common side effects include shortness of breath, upper respiratory tract infection, nausea, diarrhea, rash, and increased menstrual abnormalities.

Gefitinib (Iressa) for first-line treatment of metastatic non-small-cell lung cancer in which tumors harbor specific types of epidermal growth factor receptor gene mutations. A companion test to identify appropriate patients was also approved. A clinical trial of 106 patients resulted in tumors shrinking in about 50% of patients after treatment, and this effect lasted an average of 6 months. The most common side effects are diarrhea and skin reactions. More serious potential side effects include interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea, and ocular disorders.

The Osseoanchored Prosthesis for the Rehabilitation of Amputees (OPRA) device, the first prosthesis marketed in the U.S. for adults who have amputations above the knee and cannot use a conventional socket prosthesis. The device uses fixtures and screws implanted into the patient's remaining thigh bone to connect an external prosthetic limb. A 2-year, 51-subject clinical trial found that participants reported improved mobility, comfort, function, and quality of life compared to their own prior status. Infection was the most common adverse event.