Alerts, warnings and recalls
Patients with hepatic impairment who receive erlotinib (Tarceva) should be closely monitored during therapy, as hepatic failure, hepatorenal syndrome and fatalities have been reported in these patients who used erlotinib. Providers should also exercise extra caution when using the drug in patients with total bilirubin >3x upper limit of normal. Dosing should be interrupted or discontinued if liver function changes are severe, such as doubling of total bilirubin and/or tripling of transaminases when pretreatment values are outside the normal range.
Providers should use only approved eye wash solutionsmade by Alcon Laboratories and Akorn, Inc, because unapproved solutions made by other companies have led to eye inflammation, cloudy vision, and permanent loss of visual acuity. Providers should also avoid topical creams containing papain because they can cause hypersensitivity reactions that lead to hypotension and tachycardia.
Providers need to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 μm ) when preparing a sodium phenylacetate and sodium benzoate (Ammonul 10%/10%) injection, because the drug maker found particulate matter which could compromise the product's safety. Testing has confirmed the filter will remove the particulate.
A safety alert that epoetin alfa (Aranesp, Epogen and Procrit) may increase the risk of death for acute ischemic stroke patients. In a study using doses that were higher than those recommended to treat anemia, about 16% of patients taking the drug died compared to 9% of those taking placebo, during a 90-day period.
A class I recall of the Nebion HLX-8 Magnetic Resonance Device due to unsupported claims by the manufacturer that it could be used to treat cancer, carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device isn't approved by the FDA, lacks safety and effectiveness data, and isn't manufactured under current good practices.
A ban on more than 30 generic drugs from entering the U.S. due to deficiencies in the manufacturing process. The drugs are made by Ranbaxy Laboratories in India and include simvastatin, metformin, pravastatin, amoxicillin and clarithromycin. A list of affected drugs is available online.
Revised prescribing information for rituximab (Rituxan) to reflect a fatal case of progressive multifocal leukoencephalopathy (PML) that developed in a patient with rheumatoid arthritis. The patient received the drug in a long-term safety extension clinical study and died 18 months after taking the last dose of Rituxan. Providers should consider PML in any patient taking rituximab who presents with new onset neurologic symptoms.
ETHEX Corporation voluntarily recalled three lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed under an “ETHEX” label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with “ETHEX” and “311” on one side.
Statins don't appear to increase the incidence of amyotrophic lateral sclerosis (ALS), an FDA analysis found. The FDA began to review a possible link in 2007, after receiving a number of reports of ALS in patients on statins. It analyzed 41 long-term, placebo-controlled clinical trials, and found no higher incidence of ALS in patients treated with a statin versus placebo. More research is ongoing.
The CentriMag Right Ventricular Assist System for critically ill patients who need support for the heart's right ventricle when other therapies have failed. It's meant to be used for up to 14 days to keep the patient alive until his or her heart recovers, or until a heart transplant or long-term heart assist device can be implanted.
The Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), a genetic test that can detect and identify common influenza viruses and influenza A (H5N1) viruses within four hours.
Cepheid's Xpert MRSA/SA Blood Culture (BC) test can detect methicillin-resistant staphylococcus aureus (MRSA) and staphylococcus aureus (SA) within one hour. Romiplostim (Nplate), which directly stimulates bone marrow to produce platelets in patients with chronic immune thrombocytopenic purpura (ITP), a rare blood disorder that can lead to serious bleeding.
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.