Manufacturer asked to remove opioid from market

Details on the latest warnings, recalls, and approvals.


Recalls, withdrawals

Photo by Thinkstock
Photo by Thinkstock

A request that Endo Pharmaceuticals remove its reformulated oxymorphone hydrochloride (Opana ER) from the market. The request, which is based on the FDA's concern that the benefits of the drug may no longer outweigh the risks, marks the first time the agency has taken steps to remove an opioid from sale due to the public health consequences of misuse. The FDA reviewed all available postmarketing data, which showed a shift in the route of misuse from nasal to injection after the drug's reformulation. Misuse by injection has been associated with an outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy.

A recall of one lot of professional sample bottles containing eight tablets each of ticagrelor (Brilinta) 90-mg tablets due to a medication mix-up. At least one of the sample bottles also contained lesinurad (Zurampic) 200-mg tablets. The recalled bottles were distributed to U.S. physicians between March and April 2017.

A recall of one lot of apixaban (Eliquis) 5-mg tablets because one bottle was found to contain 2.5-mg tablets. The affected lot was distributed in February 2017.

A class I recall of SpF PLUS-Mini and SpF-XL IIB implantable spinal fusion stimulators due to higher-than-allowed levels of potentially harmful chemicals. The 33 recalled devices, which are used during spinal fusion surgery, were manufactured between Oct. 11, 2016, and Jan. 18, 2017, and were distributed between March 28 and April 6, 2017.

A recall of one lot of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1-mg/0.02-mg chewable and ferrous fumarate 75 mg) due to a packaging error. The wallet's blister was rotated 180 degrees, which reversed the weekly tablet orientation and obscured the lot number and expiration date. In effect, the first four days of intended contraceptive therapy would have provided four nonhormonal placebo tablets rather than active tablets.

A recall of all lots of TetraStem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain, and LidoMed distributed by Phillips Company. The products, intended for use as skin cleansers, hair-growth promoters, or treatment for minor cuts, scrapes, and burns, were distributed in 5-mL dropper bottles for topical application. Unexpired products made at the facility during the past three years are being recalled due to an FDA inspection that found manufacturing practices that call their safety, identity, strength, quality, and purity into question.

An expanded recall of amitriptyline tablets (50 mg) and phenobarbital tablets (15 mg, 30 mg, 60 mg, and 100 mg) due to a potential labeling mix-up. Manufacturer C.O. Truxton, Inc., initially recalled one lot of 15-mg phenobarbital tablets because a bottle was found to contain 30-mg phenobarbital tablets. The recall was expanded to include all products that were repackaged into a Truxton Incorporated label and distributed nationwide to physician and veterinarian treatment centers.

A recall of certain lots of Wingman35 crossing catheters due to tip splitting or separation, which has resulted in two adverse events. Recalled products were distributed between March 2015 and March 2017.

Approvals

A new indication for the SAPIEN 3 transcatheter heart valve as a valve-in-valve treatment. The device is now approved for use in patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve and with high risk of death or severe complications from repeat surgery. The approval is based on 314 patients who had aortic valve-in-valve procedures and 311 patients who had mitral valve-in-valve procedures. More than 85% of these patients experienced clinically meaningful improvement in their heart failure symptoms 30 days after the procedure, and observed mortality rates were substantially lower than expected, according to data from the Transcatheter Valve Therapy Registry. The device is not indicated for patients who cannot tolerate anticoagulants or those who have an active infection. Potential serious complications include death, stroke, respiratory failure, heart failure, kidney failure, and bleeding.

Edaravone (Radicava), an intravenous infusion to treat patients with amyotrophic lateral sclerosis (ALS). Efficacy was demonstrated in a six-month placebo-controlled clinical trial of 137 participants in Japan. After 24 weeks, those receiving the drug had less functional decline than those receiving placebo. The most common adverse reactions were contusion and gait disturbance. Serious risks include hives, swelling, shortness of breath, and allergic reactions to sodium bisulfite.

A new indication for ivacaftor (Kalydeco) to treat additional mutations of cystic fibrosis. The expanded approval, which was based on laboratory test results and evidence from clinical trials, triples the number of rare gene mutations that the drug can treat from 10 to 33. The drug is taken as tablets or oral granules twice per day with fat-containing food. It is indicated for patients who have one mutation in the CFTR gene that is, based on the available evidence, responsive to drug treatment. The expanded indication will impact about 900 patients, or 3% of the cystic fibrosis population. Common side effects include headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, nausea, and dizziness. Risks include elevated aminotransferase levels.

Miscellaneous

A notice that patient injuries have been reported with the use of non-Medtronic instruments with the manufacturer's NavLock Tracker. The tracker enables navigation of instruments used during spinal fusion and lumbar interbody fusion procedures with the Medronic StealthStation surgical navigation system. Both minor and serious injuries, including two patient deaths, related to using non-Medtronic instruments with the tracker have been reported. Nearly 200 associated medical device reports have been filed since 2013, and the majority of reported injuries involved spinal injury due to misaligned or misplaced screws. The manufacturer plans to update its product labeling to clarify that the NavLock Tracker should only be used with Medtronic instruments.

First-time generic approvals

Moxifloxacin hydrochloride in sodium chloride 0.8% solution (400 mg/250 mL [1.6 mg/mL] in 250 mL single-dose flexible bags) to treat infections caused by designated, susceptible bacteria. (Brand name: Avelox)

Prednisone delayed-release tablets (1 mg, 2 mg, 5 mg) as an anti-inflammatory or immunosuppressive agent for certain conditions and organ transplantation, to treat certain endocrine conditions, and to palliate certain neoplastic conditions. (Brand name: Rayos)

Dexlansoprazole delayed-release capsules (60 mg) to heal all grades of erosive esophagitis, maintain healed erosive esophagitis, relieve heartburn, and treat symptomatic nonerosive gastroesophageal reflux disease. (Brand name: Dexilant)

Ezetimibe/atorvastatin tablets (10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg) to manage lipid levels, increase HDL cholesterol levels in patients with primary hyperlipidemia or mixed hyperlipidemia, and manage cholesterol levels in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments. (Brand name: Liptruzet)

Ezetimibe/simvastatin tablets (10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg) to manage lipid levels as adjunctive therapy to diet, increase HDL cholesterol levels in patients with primary hyperlipidemia or mixed hyperlipidemia, and manage cholesterol levels in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments. (Brand name: Vytorin)

Emtricitabine and tenofovir disoproxil fumarate tablets (200 mg/300 mg) to treat HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis in combination with safer sex practices to prevent sexually acquired HIV infection in high-risk adults. (Brand name: Truvada)

Mesalamine delayed-release tablets USP (1.2 g) to induce remission in adults with active, mild-to-moderate ulcerative colitis and to maintain remission of ulcerative colitis. (Brand name: Lialda)

Nebivolol tablets (2.5 mg, 5 mg, 10 mg, 20 mg) to lower blood pressure and treat hypertension. (Brand name: Bystolic)

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)

Azelastine hydrochloride/fluticasone propionate nasal spray (137 μg/50 μg) to treat allergic rhinitis. (Brand name: Dymista)

Note: The FDA states that drugs are not always commercially available immediately after approval.