New meningitis vaccine, hepatitis C drug approved


Recalls

A recall of certain lots of several Lifecare flexible IV solutions, including dextrose, sodium chloride, and lactated Ringers, due to potential for leakage. Inspection of a product lot identified a puncture going through the overwrap and primary container, which may result in leakage that is difficult to detect.

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A recall of 10% neutral buffered formalin by Richard-Allan Scientific after defective products returned from several customers were found to have from 0% to 3% formalin content instead of the required 10%.

A recall of 1 lot of 1% lidocaine HCl for injection by Hospira due to a confirmed customer report of particulate in a single unit, identified as a human hair embedded in and attached to a pinched area of the stopper.

A recall of 1 lot of vancomycin hydrochloride for injection by Hospira because the product may have experienced temperature excursions during shipment.

A recall of 2 lots of Intravia empty plastic containers by Baxter due to complaints of particulate matter found inside the fluid path.

A recall of 3 lots of ketorolac tromethamine injection, USP, 30 mg/mL, by Sagent Pharmaceuticals, due to labeling the product with the incorrect expiration date.

A recall of EnVe and ReVel ventilators by CareFusion due to potential for damage to their power cord adaptors, which can cause loss of power and complete shutoff.

A recall of the ConMed Stat2 flow controller because it was assembled with the wrong internal component and may deliver fluid at a much higher flow rate than what is set.

A recall of GemStar power supplies for infusion pumps by Hospira because the power supply may not properly deliver electric power to the infusion pump.

A recall of all certain unexpired sterile products by Oregon Compounding Center due to lack of sterility assurance.

Approvals

Combined ledipasvir and sofosbuvir (Harvoni) to treat chronic hepatitis C virus (HCV) genotype 1 infection. It is the first combination pill approved to treat HCV and the first approved regimen that does not require interferon or ribavirin. The combo is the third drug approved in the past year for HCV, after simeprevir (Olysio) in November 2013 and sofosbuvir (Sovaldi) in December 2013. Effectiveness is based 3 trials of 1,518 patients, some treatment-naïve, others not, in which at least 94% achieved sustained virologic response.

A vaccine (Trumenba) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in patients 10 through 25 years. Previously, FDA-approved meningococcal vaccines only covered serogroups A, C, Y, and W. In 3 trials of 2,800 adolescents, 82% of those who got 3 doses had antibodies in their blood that killed 4 different serogroup B strains compared with fewer than 1% before vaccination. The most common side effects were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

The inFlow intraurethral valve-pump, a replaceable urinary prosthesis for women with impaired detrusor contractility (IDC). The device draws urine out to empty the bladder and blocks urine flow when continence is desired. A physician sizes the patient for the device and performs the initial insertion. After training, insertion and removal can be performed by the patient or a caregiver. In a trial of 273 women, over half stopped using the new device as a result of discomfort and leakage of urine, but 98% of those who continued had comparable post-void residual urine volume to that with clean intermittent catheterization. Adverse events associated with the device included asymptomatic bacteriuria; urinary tract infection; bladder inflammation; genitourinary pain; hematuria; urinary leakage; urinary frequency/urgency; bladder spasms; and vulvar, vaginal, and urethral disorders.

Nintedanib (Ofev) to treat idiopathic pulmonary fibrosis. Safety and effectiveness were established in 3 trials of 1,231 patients, in which decline in forced vital capacity was significantly reduced compared to placebo. Nintedanib is not recommended for patients who have moderate to severe liver problems, and it can cause birth defects or death to an unborn baby. The most common side effects are diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.

Pirfenidone (Esbriet) to treat idiopathic pulmonary fibrosis. Safety and effectiveness were established in 3 trials of 1,247 patients, in which decline in forced vital capacity was significantly reduced compared to placebo. Pirfenidone is not recommended for patients who have severe liver problems or end-stage kidney disease or who require dialysis. It should be taken with food to minimize the potential for nausea and dizziness, and patients should avoid or minimize exposure to sunlight and sunlamps. The most common side effects are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased/loss of appetite, gastroesophageal reflux disease, sinusitis, insomnia, decreased weight, and arthralgia.

New labeling with abuse-deterrent features for morphine sulfate and naltrexone hydrochloride (Embeda) extended-release, approved to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment. The new labeling includes a claim that the drug is expected to reduce, but not totally prevent, oral abuse when crushed. When crushed, naltrexone blocks some of the euphoric effects of morphine and can precipitate withdrawal in persons dependent on opioids. The FDA is requiring postmarketing studies to further assess the effects of the abuse-deterrent features.

Miscellaneous

Specific lots of atropine (AtroPen), diazepam (CANA), morphine sulfate, and pralidoxime chloride auto-injectors, manufactured by Meridian Medical Technologies, can be used for up to an additional year beyond the labeled expiration date, the FDA said. This action is taken to mitigate potential shortages of these medically necessary drugs. To help assure patient safety, products should have been and should continue to be stored under the recommended storage conditions.

Liraglutide (Victoza) carries a potential risk of medullary thyroid carcinoma and acute pancreatitis and so is not recommended as first-line therapy for diabetes, a recent safety notice from the manufacturer reminded clinicians.