Wrong drug route can be deadly
The U.S. Food and Drug Administration (FDA) has asked Bayer, maker of nimodipine (Nimotop), to add a boxed warning to the product labeling, alerting clinicians to medication administration errors. The agency requested the action after it received reports of administration errors in which the drug was given intravenously or parenterally, rather than orally.
In addition to a fatal case reported last year, there has been a history of these errors, the FDA states. Although Bayer included a bold warning on nimodipine's labeling after a 1996 death resulting from an error, cases are still occurring. The FDA has also asked Bayer to develop an oral solution of nimodipine for use in patients who can't swallow capsules.
The drug, approved for oral administration to improve neurological outcome after subarachnoid hemorrhage, can cause serious adverse events, including death, when administered intravenously or parenterally.
For patients unable to swallow a capsule, clinicians should use a syringe to extract the gel from the capsule. The syringe should be labeled "for oral use only." Clinicians should administer the gel to the patient through a nasogastric tube, followed by 30 mL of normal saline solution (0.9%).
Source: FDA. Alert for healthcare professionals: nimodipine (marketed as Nimotop). Available at: http://www.fda.gov/cder/drug/InfoSheets/HCP/nimodipineHCP.htm. Accessed April 15, 2006.
Heart risk warnings recommended for ADHD drugs
An FDA advisory panel recommended that prescription medications to treat attention deficit/hyperactivity disorder (ADHD) come with strong black box warnings, advising users that the drugs may increase the risk of heart problems in some patients. The panel also recommended that the medications be dispensed with a patient-friendly guide that would explain possible side effects.
According to an earlier FDA report, 24 deaths have occurred among patients who took amphetamine and dextroamphetamine (Adderall) through 2003. Another 16 deaths were reported through 2003 in patients who took methylphenidates (Ritalin), the FDA report found. Ten deaths were reported among people taking other drugs in the amphetamine class.
The FDA report did not state that the medications were responsible for the fatalities, but it recommended close monitoring of cardiac problems in children who take these medications.
Source: Richwine L. U.S. reports deaths of patients taking drugs for ADHD. Available at: http://www.medscape.com/viewarticle/523212. Accessed April 15, 2006.
Reuters Health. U.S. panel urges heart risk warning on ADHD drugs. Available at: http://www.medscape.com/viewarticle/523343. Accessed April 15, 2006.
Injectable bulking agent approved for stress incontinence
The FDA approved a synthetic injectable implant, Coaptite, for soft-tissue augmentation in the treatment of urinary stress incontinence due to intrinsic sphincteric deficiency in adult women.
The implant contains spherical calcium hydroxyapatite (CaHA) particles suspended in an aqueous-based gel carrier. It's injected submucosally in several places around the bladder neck during an outpatient procedure. The carrier dissipates over several months while the CaHA particles remain in place at the injection sites. The particles increase tissue bulk and augment soft tissue at the bladder neck and urethra, causing urethral coaptation that increases resistance to urine leakage.
Commonly observed adverse events included urinary retention, hematuria, dysuria, urinary tract infection, urinary urgency, frequent urination, and urge incontinence.
The product should not be used in patients who have a significant history of urinary tract infections without resolution, current or acute conditions of cystitis or urethritis, and a fragile urethral mucosal lining.
Source: FDA. New device approval: Coaptite-P040047. Available at: http://www.fda.gov/cdrh/mda/docs/p040047.html. Accessed April 15, 2006.
FDA approved new lab test to detect human avian flu
A new laboratory test that diagnoses H5 influenza strains in patients suspected to be infected with the virus is now approved by the FDA. The test, Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set, was developed by the U.S. Centers for Disease Control and Prevention (CDC).
The test provides preliminary results on suspected H5 influenza samples within 4 hours, once a sample arrives at the lab and testing begins. Previous technology required at least 2 to 3 days to produce results. If the H5 strain is identified, further testing is done to identify the H5N1 subtype.
Source: U.S. Centers for Disease Control and Prevention. New laboratory assay for diagnostic testing of avian influenza A/H5 (Asian lineage). MMWR. 2006;55(Early Release):1. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55e203a1.htm. Accessed April 15, 2006.
Two antivirals flagged this flu season
The CDC announced that clinicians should not prescribe amantadine (Symmetrel) and rimantadine (Flumadine) to treat or prevent influenza during influenza season because the predominant strain of influenza circulating in the United States (H3N2) shows resistance to these drugs.
The CDC tested 120 influenza A (H3N2) virus isolates and found that 109 (91%) were resistant to amantadine and rimantadine, a sharp increase from last year when only 11% of isolates tested were resistant, and from 2004 when only 1.9% were resistant.
The CDC noted that all H1 and H3 influenza viruses tested to date were susceptible to oseltamivir (Tamiflu) and zanamivir (Relenza). During this period, the CDC recommends that oseltamivir and zanamivir be prescribed if an antiviral is needed for the treatment or prevention of influenza.
Source: CDC. CDC health alert. Available at: http://www.cdc.gov/flu/han011406.htm. Accessed April 15, 2006.
Hepatitis B diagnostic kit recalled
Ortho-Clinical Diagnostics and the FDA notified healthcare practitioners of a class 1 recall of the company's HBsAg Confirmatory Kit. An unknown component in the diluting solution used to test blood and serum samples may produce "Not Confirmed" results for samples found positive with the initial test.
Such false-negative test results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially important for pregnant women whose tests show false-negative results. When their fetuses are born, they'll be presumed negative and not treated with the HBIG (hepatitis B immunoglobulin) and hepatitis B vaccine. Such infants have a 90% chance of progressing to chronic hepatitis B virus infection, resulting in possible liver transplantation or early death.
Previously reported results should also be reviewed, according to the company.
Source: U.S. Food and Drug Administration. Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit. 2006 safety alerts for drugs, biologics, medical devices, and dietary supplements. Available at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#vitros. Accessed April 15, 2006.
Immunoassay received expanded indication
The FDA approved a new indication for Roche Diagnostics' Elecsys NT-proBNP test for the quantification of N-terminal proB-type natriuretic peptide in serum plasma, allowing its use to assess the risk of cardiac events in patients with stable coronary artery disease (CAD).
The assay is the first natriuretic peptide test approved for this indication. Previously, the assay was approved as an aid in diagnosing congestive heart failure (CHF) and as a risk marker for patients with acute coronary syndrome and CHF.
The fully automated assay provides rapid results (in as little as 18 minutes) using serum or plasma samples and is compatible with routine lab testing. The test helps to identify patients requiring further cardiac assessment, leading to more cost-effective use of echocardiography.
Source: Roche Diagnostics. Product detail. Available at: http://www.roche-diagnostics.com/products_services/elecsys_probnp.html. Accessed April 15, 2006.
Certain Accu-Chek Aviva glucose meters recalled
Roche Diagnostics has initiated a worldwide voluntary recall of certain Accu-Chek Aviva glucose meters because of the potential for an electronic malfunction that can cause the meter to report an erroneous result or shut down.
The recall includes U.S. serial numbers 52500000000 through 52510999999. In the United States, people with these meters can call a toll-free number for a product replacement (1-888-591-5084.) The recall does not apply to meters with U.S. serial numbers 52511000000 and higher, nor does it apply to Accu-Chek Aviva test strips.
Visit the Accu-Chek Web site (http://www.accu-chek.com) for more information concerning the recall.