Recalls, warnings, safety alerts
A recall of certain drug products due to a lack of sterility assurance. Recalled products manufactured by Hospira include 42 lots of 8.4% sodium bicarbonate injection USP (50-mL vials), five lots of sodium bicarbonate 4% additive solution (5-mL vials), five lots of succinylcholine chloride injection USP (200-mg/10-mL vials), and seven lots of potassium phosphates injection USP (45-mMol vials). Affected products were distributed from January to June 2017. The recall has resulted in multiple secondary recalls from other manufacturers.
A recall of one lot of apixaban (Eliquis) 5-mg tablets to the retail/dispensing level due to a customer complaint that a bottle contained 2.5-mg tablets. Recalled products were distributed in February 2017.
A recall of all lots of nitroglycerin injection in 5% dextrose USP products produced at Advanced Pharma, Inc.'s Houston location from March 3 through May 31, 2017. The recall is due to laboratory test results indicating lower-than-expected potency of certain lots of the drugs, which were distributed to health care facilities between March 9 and June 1, 2017.
A recall of Venture catheters due to the risk of the catheter tip splitting or separating during use. The recall of more than 7,000 catheters includes all unexpired lots of the Rapid Exchange, Over-the-Wire, and Coronary Sinus versions of the device.
A recall of all unexpired sterile drug products by Cantrell Drug Company due to a lack of sterility assurance. Affected products were distributed from Feb. 16 to July 19, 2017.
A recall of seven lots of clindamycin injection USP in ADD-Vantage vials due to lack of sterility assurance. Affected products were distributed between May 2016 and June 2017.
A recall of certain batches of NovoPen Echo insulin cartridge holders because they may crack or break if exposed to certain chemicals, such as cleaning agents. Related adverse events and other complaints have been reported, and affected products were distributed between Aug. 1, 2016, and June 22, 2017. The manufacturer has corrected the problem and is providing replacement cartridge holders for consumers whose devices were affected by the recall.
A recall of one lot of paliperidone extended-release tablets (3 mg, 90-count bottles) due to failed test results for dissolution. Subtherapeutic levels could occur if patients with schizophrenia and schizoaffective disorders take two or more consecutive dosing regimens with affected tablets. However, the probability of this happening is low, and no related adverse events have been reported, according to the manufacturer's investigation.
A worldwide field correction of certain intra-aortic balloon pumps due to a potential electrical test failure code. Due to a complaint that was linked with a patient death due to failure of the device to initiate therapy, the manufacturer is replacing defective parts in about 12,000 System CS100, CS100i, and CS300 intra-aortic balloon pumps. Affected devices were distributed between March 23, 2003, and Dec. 11, 2013.
A recall of all ED-530XT duodenoscopes, which need to have replacements of the forceps elevator mechanism (including the O-ring seal) and the distal end cap, as well as new operation manuals. After receiving the new operation manuals, affected customers should remove, replace, and destroy any older operation manuals, the FDA recommends. The agency outlined validated manual reprocessing instructions, which facilities should continue to use when cleaning and disinfecting the duodenoscopes, in a December 2015 safety communication.
A recall of ATAR extension cables due to the potential separation of the cable from the connector at the proximal end. Of 66 related complaints, five incidents resulted in patient injuries.
A class I recall of the Penumbra 3D Revascularization Device due to the risk of the delivery wire breaking or separating during use. The recall includes 155 devices distributed nationwide between May 15 and June 7, 2017.
L-glutamine oral powder (Endari) to reduce severe complications associated with sickle cell disease. The orphan drug's safety and efficacy were evaluated in a trial of patients ages 5 to 58 years with sickle cell disease who had two or more painful crises within the preceding 12 months. Over 48 weeks of follow-up, patients treated with the drug experienced fewer sickle cell crises on average, compared to those who received placebo (median of three vs. median of four), as well as fewer hospitalizations for sickle cell pain (median of two vs. median of three) and fewer days in the hospital (median of 6.5 days vs. median of 11 days). Patients who received the drug also had fewer occurrences of acute chest syndrome compared with those who received placebo (8.6% vs. 23.1%). Common side effects include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain, and chest pain.
Voxilaprevir in combination with sofosbuvir and velpatasvir (Vosevi) to treat adults with chronic hepatitis C virus (HCV) genotypes 1 through 6 who have mild or no cirrhosis. The fixed-dose tablet is the first treatment approved for patients who have been previously treated with sofosbuvir or other HCV drugs that inhibit nonstructural protein 5A (NS5A). Its safety and efficacy were tested in two clinical trials of about 750 adults with mild or no cirrhosis. Overall, 96% to 97% of patients who received the new combination drug had no virus detected in their blood 12 weeks after completing treatment. Treatment recommendations for the drug vary based on the patient's viral genotype and treatment history. Due to concerns about hepatitis B virus (HBV) reactivation in co-infected patients, clinicians should screen for current or prior HBV infection before starting treatment with the new drug. The most common adverse reactions in patients taking the drug were headache, fatigue, diarrhea, and nausea. The drug is contraindicated in patients taking rifampin.
Haegarda (a C1 esterase inhibitor derived from human plasma) to prevent hereditary angioedema attacks in adolescent and adult patients. The orphan drug is administered subcutaneously by the patient or caregiver after proper training. It is indicated for routine prophylaxis to prevent attacks of hereditary angioedema, not to treat acute attacks. The drug's efficacy was demonstrated in a multicenter controlled trial of 90 participants ages 12 to 72 years with symptomatic hereditary angioedema. Participants were randomized to receive two weekly subcutaneous doses of either 40 IU/kg or 60 IU/kg. During 16 weeks of treatment, both doses were associated with a significantly reduced number of attacks than in placebo treatment periods in the same patients. The most common side effects were injection site reactions, hypersensitivity reactions, nasopharyngitis, and dizziness. The drug should not be used in patients who have experienced life-threatening hypersensitivity reactions to a C1 esterase inhibitor preparation or its inactive ingredients.
Expanded use of a cooling cap (DigniCap Cooling System) to reduce the frequency and severity of hair loss during chemotherapy in cancer patients with solid tumors. As part of the computer-controlled system, patients wear a cap that circulates liquid to cool the scalp during chemotherapy treatment. A second neoprene cap acts as an insulation cover and holds the cooling cap in place. By constricting the scalp's blood vessels, the cooling cap can reduce the amount of chemotherapy that reaches cells in the hair follicles. The FDA in 2015 authorized marketing of the cap for use in patients with breast cancer based on a study of 122 women with stage I or II breast cancer who were receiving chemotherapy in which 66% of women reported losing less than half their hair with the cap. The FDA based expanded approval on data from cancer patients with solid tumors in other areas of the body. The most common side effects are cold-induced headaches and neck and shoulder discomfort, chills, and pain when wearing the cap for extended periods of time. Long-term side effects and the risk of scalp metastasis have not been fully studied.
Authorization of the first test for use with flow cytometry to help detect several types of leukemia and lymphoma. The test, ClearLLab Reagents (T1, T2, B1, B2, M), detects cancerous cells in blood, bone marrow, and lymph nodes and informs laboratories and clinicians which type of leukemia or lymphoma is present. A multisite study of 279 samples compared the test's results to alternative detection methods and found that the test matched the study site's final diagnosis 93.4% of the time and correctly detected the presence of cancer 84.2% of the time. The FDA is establishing criteria to clarify its expectations in assuring the test's accuracy, reliability, and clinical relevance.
An update on Pfizer drug shortages. Several injectable drugs are facing shortages, including sodium bicarbonate injection (vials and syringes), dextrose 50% injection (vials and syringes), and emergency syringes of such other drugs as epinephrine, calcium chloride, and atropine sulfate. The FDA is working with the manufacturer to resolve the issue by addressing the underlying causes, which include manufacturing, distribution, and third-party delays. Solutions include finding alternative manufacturers of the drugs.
First-time generic approvals
Doxycycline hyclate tablets USP (75 mg, 150 mg) to treat rickettsial, sexually transmitted, respiratory tract, ophthalmic, and specific bacterial infections; to treat anthrax, including inhalational anthrax (postexposure); as an alternative treatment for certain infections when penicillin is contraindicated; as adjunctive therapy for acute intestinal amebiasis and severe acne; and as prophylaxis of malaria. (Brand name: Acticlate)
Emtricitabine and tenofovir disoproxil fumarate tablets (200 mg/300 mg) in combination with other antiretroviral agents to treat patients with HIV-1 infection and in combination with safer sex practices as pre-exposure prophylaxis to prevent sexually acquired HIV infection in high-risk adults. (Brand name: Truvada)
Prasugrel tablets (5 mg, 10 mg) to reduce thrombotic cardiovascular events, including stent thrombosis, in certain patients with acute coronary syndrome who will be managed with percutaneous coronary intervention. (Brand name: Effient)
Rosiglitazone maleate and metformin hydrochloride tablets (1 mg [base]/500 mg) to improve glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise. (Brand name: Avandamet)
Mesalamine delayed-release tablets USP (1.2 g) to induce remission and maintain remission in ulcerative colitis. (Brand name: Lialda)
Paroxetine capsules (7.5 mg) to treat moderate to severe vasomotor symptoms associated with menopause. (Brand name: Brisdelle)
Phentermine hydrochloride orally disintegrating tablets (15 mg, 30 mg, 37.5 mg) as a short-term adjunct to manage exogenous obesity for certain patients as part of a weight-reduction regimen based on exercise, behavioral modification, and caloric restriction. (Brand name: Suprenza)
Sevelamer carbonate powder for oral suspension (0.8 g, 2.4 g) to control serum phosphorus in adults with chronic kidney disease on dialysis. (Brand name: Renvela)
Atomoxetine capsules USP (10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg) to treat attention-deficit/hyperactivity disorder. (Brand name: Strattera)
Note: The FDA states that drugs are not always commercially available immediately after approval.