New labeling on long-acting opioids and fluoroquinolones

Details on recalls, warnings and approvals.


Recalls, warnings and label changes

A labeling change for all extended-release and long-acting (ER/LA) opioid analgesics to combat misuse and abuse of the drugs. The updated indication states that ER/LA opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, and it further clarifies that, because of the risks of addiction, abuse and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for patients for whom alternative treatment options are ineffective, are not tolerated, or would be otherwise inadequate to provide sufficient management of pain. A new boxed warning will caution that chronic maternal use during pregnancy can result in neonatal opioid withdrawal syndrome. The FDA is also adding new postmarket study requirements to further assess the risks of misuse, abuse, hyperalgesia, addiction, overdose and death.

Image from Thinkstock
Image from Thinkstock.

A labeling change on fluoroquinolone drugs to better describe the serious side effect of peripheral neuropathy. The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. This side effect may occur soon after these drugs are taken and may be permanent. If a patient develops symptoms of peripheral neuropathy, he or she should be switched to another antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.

A recall of Iradimed Corp. MRidium 3860+ infusion systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit because the DERS can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup. This can result in over-infusion or under-infusion and serious adverse health consequences, including death.

A recall of certain Hospira blood sets due to customer reports of the outer wall of blood bags being punctured with the piercing pin during insertion of the pin, which may result in spillage of the blood and blood products stored in the bag and a delay or interruption in therapy. This issue has been identified as a contributing factor in 1 patient death.

A recall of Siemens MicroScan Synergies Plus and MicroScan RapID/S Plus negative panels because they may report false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when used with the MicroScan WalkAway System. This error may lead to treatment with an inappropriate antibiotic or a delay in appropriate therapy.

A recall of Hospira bupivacaine HCl injection due to reports of foreign particulates, which were identified as stainless steel and iron oxide.

A product labeling update on the Cordis Optease retrievable inferior vena cava filter to clarify a previous recall and minimize likelihood of implanting the filter backward.

A recall of 1 lot of Hospira's aminosyn II 10%, sulfite-free, 500 mL, due to 1 report of a foreign particle, which was identified as human hair.

A recall of repackaged products sent by Aidapak Services LLC to hospitals in Washington, Oregon, California and Arizona, due to possible incorrect labeling of over-the-counter, prescription and dietary supplement products. This could result in patients receiving drugs that were not prescribed, which may pose serious or life-threatening risks to a patient's health.

A recall of certain lots of Covidien Monoject prefill flush syringes due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. These products are labeled as either sodium chloride flush or heparin lock flush, and some but not all syringes have mismatched syringe tip cap, syringe label, filled volume and wrapper. This issue poses a risk of life-threatening infection or clotting.

A recall of 9 lots of carboxymethylcellulose sodium 0.5% ophthalmic solution, 30 mL, by Altaire Pharmaceuticals, Inc., due to complaints of mold found in the bottles after use.

A recall of all lots of unexpired sterile products from Specialty Compounding, LLC, after reports of bacterial infection affecting 15 patients at 2 Texas hospitals. There is a potential association between the infections and the medication.

A number of recalls due to a recent unsatisfactory FDA inspection of Front Range Laboratories, which performed testing for compounding pharmacies, including:

  • 2 lots of methylcobalamin 5 mg/mL, 30 mL and Multitrace-5 Concentrate 10 mL for injection and 1 lot of testosterone cypionate (sesame oil) from Park Pharmacy & Compounding Center,
  • 2 lots of bevacizumab and 1 lot of lidocaine/phenylephrine from Leiter's Compounding Pharmacy,
  • 6 lots of dialysis drug products from JCB Laboratories,
  • certain lots of dexpanthenol 250 mg/mL, magnesium sulfate 50%, methylcobalamin 1 mg/mL, sodium phenylbutyrate 200 mg/mL, R.L. glutathione 100 mg/mL, and ascorbic acid (cassava) 500 mg/mL from Wellness Pharmacy, Inc.,
  • compounded bevacizumab 1.25 mg/0.05 mL PF and vancomycin PF (BSS) 1% from Avella Specialty Pharmacy,
  • and certain sterile products from Medaus Pharmacy and University Compounding Pharmacy.

A recall of DePuy Orthopaedics LPS Lower-Extremity Dovetail Intercalary Component due to the potential for fracture when exposed to normal physiologic loads while walking, which may lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery. Patients weighing more than 200 pounds and/or those with high levels of activity are at higher risk of fracture.

A recall of Verathon, Inc., GlideScope Video Laryngoscope 3, 4, 5 and reusable blades due to the potential risk of breakage and premature failure of the blade tip. Device failure may not be readily visible during routine inspection before or after insertion of the laryngoscope, which could result in pieces of the blade breaking off in patients' mouths and being swallowed or blocking the airway.

Approvals

The Alere Determine HIV-1/2 Ag/Ab Combo test, the first rapid test for simultaneous detection of both HIV-1 antigen and HIV-1/2 antibodies in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, it is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.

Dolutegravir (Tivicay) to treat HIV-1 infection. A daily pill taken with other antiretrovirals, dolutegravir is an integrase strand transfer inhibitor that interferes with 1 of the enzymes necessary for HIV to multiply. It is approved for use in a broad population of adult HIV patients, both treatment-naive and treatment-experienced, including those who have been treated with other integrase strand transfer inhibitors, as well as children ages 12 years and older weighing at least 40 kg who have not previously taken other integrase strand transfer inhibitors. Common side effects include insomnia and headache. Serious side effects include hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B or C.

The VITEK MS, the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The system can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about 1 minute. In testing, it correctly identified the scientific group or family of a specimen 93.6% of the time (with 87.5% of microorganisms identified to species level) and provided a “no identification” result for 3.2% of the microorganisms in the study. Only 0.8% of results were incorrect, and 2.4% were low discrimination with no correct result.

A new indication for onabotulinumtoxinA (Botox Cosmetic) to provide temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow's feet, in adults. Safety and effectiveness were established in 2 clinical studies with 833 adult participants who were randomly assigned to receive treatment or placebo. Treated patients had greater improvement in the appearance of lateral canthal lines. The most common adverse reaction is eyelid edema.

The UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate. Approval was based on data from 2 studies of men with benign prostatic hyperplasia implanted with 2 or more UroLift sutures, in which physicians successfully inserted the device in 98% of participants, resulting in a 30% increase in urine flow, a decrease in symptoms, and an increase in quality of life. Adverse events include pain or burning during urination, blood in the urine, frequent or urgent need to urinate, incomplete emptying of the bladder, and decreased urine flow.

A new indication for paclitaxel (Abraxane) protein-bound particles for injectable suspension (albumin-bound) to treat patients with metastatic pancreatic cancer. It is intended to be used with gemcitabine. Safety and effectiveness were established in a trial of 861 participants randomly assigned to receive it with gemcitabine or gemcitabine alone; treated patients lived, on average, 1.8 months longer. Common side effects include neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, rash and dehydration. Other clinically important serious side effects included sepsis and pneumonitis. The drug was previously approved to treat breast cancer and non-small-cell lung cancer.

The Xpert MTB/RIF Assay, the first U.S. test for simultaneous detection of tuberculosis (TB) bacteria and resistance to rifampin. The new test is less complex to perform than previous FDA-cleared tests for the detection of TB bacteria, and test results are available in approximately 2 hours.

Miscellaneous

The FDA recently alerted the public that a patient in Europe with possible multiple sclerosis (MS) developed progressive multifocal leukoencephalopathy (PML) after taking fingolimod (Gilenya). This is the first case of PML reported following the administration of fingolimod to a patient who had not previously received natalizumab (Tysabri). The patient received nearly 8 months of fingolimod treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for 1 month before initiating fingolimod; those medications were stopped when fingolimod was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during fingolimod treatment. The FDA is providing this alert while continuing to investigate the PML case and working with the drug's manufacturer to obtain and review all available information. The agency will communicate conclusions and recommendations after the evaluation is complete.

The manufacturer of phentermine and topiramate extended-release capsules (Qsymia) reminds physicians about the drug's risks of teratogenicity and recommended steps to ensure safe and appropriate use. The Qsymia Healthcare Provider Training Program is available online. The drug is now available through certified retail pharmacies in addition to mail-order pharmacies, but certified pharmacies must provide a Medication Guide and the “Risk of Birth Defects with Qsymia” patient brochure with every prescription and every refill.