Warnings about long-term dual antiplatelet therapy, gram-negative tests


Recalls and warnings

A safety announcement on long-term dual antiplatelet therapy, after a study found a decrease in the risk of heart attacks and clot formation, but increased overall risk of death with treatment for 30 months after stent implantation compared to 12 months. The FDA is continuing to evaluate available data and will communicate final conclusions and recommendations in the future. In the interim, clinicians should not change the way they prescribe these drugs, the agency said.

A recall of rapid gram-negative combo panels by Siemens Healthcare Diagnostics because they may produce incorrect results for certain antibiotics. The test may report certain bacteria as sensitive to aztreonam, cefotaxime, ceftazidime, and ceftriaxone when the bacteria are actually resistant.

Art 1

A safety announcement about generic methylphenidate hydrochloride extended-release tablets, made by Mallinckrodt and Kudco, because the drugs may not be therapeutically equivalent to the brand-name drug. Based on adverse event reports, a re-examination of previously submitted data, and laboratory tests, the FDA has found that the generics may deliver medication more slowly 7 to 12 hours after a dose. The therapeutic equivalence rating has been changed from AB to BX, meaning that they are still approved and can be prescribed, but are no longer recommended as automatically substitutable.

A recall of 1 lot of gabapentin capsules, USP 300 mg, by Aurobindo Pharma USA, because the lot has been found to contain some empty capsules.

A recall of some Puritan Bennett 980 ventilator systems because of a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected.

A recall of Esprit V1000 and V200 ventilators with 3rd Generation power supplies because a part in the power supply may prevent the ventilator from using AC power or may fail and prevent the ventilator from switching back to AC power after using battery power.

A recall of 1 lot of highly concentrated potassium chloride injection, 10 mEq per 100 mL, due to a complaint of mislabeling of the overpouch, which could result in the administration of a dose lower than intended.

A recall of additional sterile convenience kits by Customed, Inc., because of a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection.

A safety communication on dimethyl fumarate (Tecfidera) by Biogen after a patient with multiple sclerosis being treated with the drug developed progressive multifocal leukoencephalopathy (PML) and later died. The patient was not taking any other drugs that affect the immune system or are thought to be associated with PML. Clinicians should warn patients to contact them about any symptoms that may be suggestive of PML.

A device correction for PadPro and R2 multi-function defibrillation electrodes by CONMED and Heart Sync Inc. multi-function defibrillation electrodes due to a connector compatibility issue with Philips FR3 and FRx defibrillator units.

A recall of the Gel-E Donut and Squishon 2 by Children's Medical Ventures due to complaints of visible mold on the devices.

Approvals

HeartFlow FFR-CT software to non-invasively evaluate blood flow in the coronary arteries. The software can provide an estimate of fractional flow reserve (FFR) using data from a CT scan of the patient's heart. Clinicians can use the estimate, along with other patient data, to determine the likelihood that the actual FFR is below accepted limits and whether or not cardiac catheterization is necessary.

Hydrocodone bitartrate (Hysingla ER), an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The formulation has properties that are expected to reduce, but not totally prevent, abuse. It is difficult to crush, break or dissolve; forms a viscous hydrogel; and cannot be easily prepared for injection. Strengths contain 20, 30, 40, 60, 80, 100 and 120 mg of hydrocodone to be taken every 24 hours. Doses of 80 mg per day and higher should not be prescribed to opioid non-tolerant patients. The most common side effects are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence. The FDA is requiring postmarketing studies to assess the effects of the abuse-deterrent features.

A new indication for ruxolitinib (Jakafi) to treat polycythemia vera in patients who have an inadequate response to or cannot tolerate hydroxyurea. The most common side effects were anemia and thrombocytopenia. The most common non-blood related side effects were dizziness, constipation, and shingles. The drug was approved in 2011 for treatment of intermediate or high-risk myelofibrosis.

Miscellaneous

A new rule about the labeling of prescription drugs related to pregnancy and lactation. The letter categories (A, B, C, D and X) are being removed and drug labels will now have a pregnancy subsection, which includes information for a pregnancy exposure registry, a lactation subsection about using the drug while breastfeeding, and a new “females and males of reproductive potential” subsection with information about the need for pregnancy testing, contraception recommendations, and infertility.