Actavis recalls more than 60 generics, six flu vaccines OK'd

Recalls, warnings, alerts and label changes

A recall of more than 60 Actavis generic drugs after an FDA inspection showed the company's operations didn't meet good manufacturing practices. The recall affects all products made at Actavis' Little Falls, N.J. facility, including oxycodone, glyburide, guanfacine and mirtazapine. A full list of recalled drugs is available.

An alert to discontinue exenatide (Byetta) if a patient appears to develop pancreatitis. Six cases of hemorrhagic or necrotizing pancreatitis were reported in the last year in patients taking Byetta; two died. Patients with a history of pancreatitis should be considered for antidiabetics other than Byetta.

A Class 1 recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008, because the tip of the stent delivery system may detach during a procedure. The recall doesn't affect stents that have already been implanted.

A Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles because it may result in injury or death. Levitronix recently issued a letter warning doctors not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because such use may result in stoppage of the pump and cause serious injury or death.

An alert to avoid prescribing more than 20 mg of simvastatin (Zocor, Vytorin, Simcor) per day if a patient is taking amiodarone (Cordarone, Pacerone), as the combination increases the risk of rhabdomyolysis, especially at simvastatin levels above 20 mg/daily.

A warning not to buy or use Viapro 375-mg capsules because one lot of the product was found to contain the potentially harmful undeclared ingredient thio-methisosildenafil, which is an analogue of sildenafil. The undeclared ingredient may interact with nitrates found in some prescription drugs, and can lower blood pressure to dangerous levels.

A label change clarifying use of epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp) to treat anemia in patients undergoing chemotherapy. Treatment should only begin when a patient's hemoglobin level drops to 10 g/dL, and the drugs shouldn't be used when the expected outcome of chemotherapy is to cure a patient of cancer.

A reminder that left ventricular ejection fraction (LVEF) should be evaluated before initiating treatment with, and administering each dose of, mitoxantrone. Previous post-marketing reports about decreases in LVEF or frank congestive heart failure in some patients led to recommendations about monitoring patients, but research indicates there is poor adherence to these recommendations.

An alert about the risk of adverse reactions to naltrexone injections for alcohol dependence. An intramuscular gluteal injection, naltrexone shouldn't be given intravenously, subcutaneously or inadvertently into fatty tissue. Doctors should tell patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness that doesn't improve within two weeks. Patients with site reactions should be referred to a surgeon.

Approvals

Intravenous clevidipine butyrate (Cleviprex) to reduce blood pressure. The dihydropyridine calcium-channel blocker has a quick onset and offset of action that can be titrated for exact control in a critical care setting. The drug may produce systemic hypotension and reflex tachycardia; its most common adverse reactions are headache, nausea and vomiting.

Divalproex sodium, the first generic version of Depakote delayed-release tablets to treat seizures, bipolar disorder and migraines. Like Depakote, the generic has a boxed warning about the risk of hepatotoxicity, pancreatitis and birth defects.

Six vaccines for the upcoming flu season, all of which contain influenza virus strains that are completely different from last year. The virus strains this year are an A/Brisbane/59/2007 (H1N1)-like virus; an A/Brisbane/10/2007 (H3N2)-like virus; and a B/Florida/4/2006-like virus. The vaccines are Afluria, Fluarix, FluLaval, FluMist, Fluvirin and Fluzone. All health care workers should be vaccinated, the FDA said.

The Pathwork Tissue of Origin, which helps determine the kind of cancer cells present in a malignant tumor. The test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database, and considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.

Tenofovir disoproxil fumarate (Viread) for chronic hepatitis B in adults, with a recommended daily dose of 300 mg. The drug has been available in the U.S. since 2001 to treat HIV infection. Patients who discontinue Viread should be monitored closely for several months, as acute exacerbations of hepatitis have occurred in those who stopped treatment.