New combo vaccine for MMR includes chickenpox
Merck's ProQuad combination vaccine is now approved to protect children 12 months to 12 years of age against measles, mumps, rubella, and chickenpox. The vaccine, which combines two previously approved vaccines (M-M-R II and Varivax), is the first to target all four diseases in a single shot.
ProQuad is also approved for use in children 12 months to 12 years of age if a second dose of measles, mumps, and rubella vaccine is administered.
In clinical trials, researchers compared the immunogenicity, antibody persistence, and safety of ProQuad with its component vaccines. ProQuad demonstrated antibody persistence at 1 year after vaccination of 98.9% against measles, 96.7% against mumps, 99.6% against rubella, and 97.5% against chickenpox.
BNP test aids assessment of rehospitalization, mortality risk
A new indication was approved for Biosite's Triage BNP plasma B-type natriuretic peptide test, to allow its use as an aid in assessing rehospitalization and mortality risks in patients with heart failure (HF). The product was previously approved as an aid in the diagnosis of CHF, assessment of CHF severity, and in risk stratification of patients with acute coronary syndromes.
The approval of the expanded indication came after studies showed the relative risk of death increased by 35% for every 100 pg/ml increase in BNP concentration, and that HF patients whose BNP values didn't decrease over the course of treatment were at a particularly high risk of death or a cardiovascular event.
Once-daily formulation of pain medication approved
A once-daily formulation of tramadol HCl (Tramadol ER) has been approved by the FDA for the treatment of moderate to moderately severe chronic pain.
Tramadol ER will be available in 100-mg, 200-mg, and 300-mg dosage strengths. Tramadol ER is a product of Biovail, which plans to launch the medication commercially in early 2006.
First biologic approved to treat ulcerative colitis
The FDA approved Johnson & Johnson's infliximab (Remicade) as the first and only biologic to treat ulcerative colitis. Infliximab is now approved for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis, who've had an inadequate response to conventional therapy. The drug was previously approved to treat Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
The new approval was based on the results of three clinical trials of infliximab in over 700 patients with active, moderate-to-severe ulcerative colitis. Significantly higher proportions of patients receiving infliximab achieved clinical response at week 8 versus placebo-treated patients, and the response was maintained at week 30 in 52% of patients taking 5 mg/kg of infliximab and 51% of patients taking 10 mg/kg of infliximab versus 30% of placebo-treated patients.
Infliximab-treated patients were also significantly more likely to achieve mucosal healing at week 8 versus placebo-treated patients, and a significantly greater proportion of patients treated with infliximab were able to discontinue corticosteroid therapy while in remission at week 30 compared with placebo-treated patients.
Serious adverse events associated with G.I. treatment
The FDA and Boston Scientific have notified healthcare providers and patients about serious adverse events, including death, that have occurred in patients treated with Enteryx liquid chemical polymer, which is injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease.
Boston Scientific has issued a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. According to the FDA, practitioners should stop injecting Enteryx immediately and follow the manufacturer's procedures for returning unused product.
The serious adverse events associated with Enteryx involve unrecognized transmural injections of Enteryx into structures surrounding the esophagus. Transmural injections can potentially result in death or serious injury. Some cases of transmural injections weren't recognized at the time of the procedure or during immediate follow-up despite the use of fluoroscopy during the procedure.
The number of adverse events associated with transmural injection of Enteryx isn't yet known. The FDA is aware that not all injuries are caused by user technique or transmural injection; recent literature cites two cases in which serious mediastinal events suggestive of possibly inflammatory reactions occurred even though proper procedure was followed.
Other adverse events not associated with transmural injection have also been reported to the FDA, including dysphagia and weight loss.
Ropinirole labeling addresses somnolence
Labeling changes have been made to SmithKline Beecham's ropinirole HCl (Requip) to warn of the risk of somnolence and the rarer risk of syncope, hypotension, and hallucinations associated with its use in patients with moderate-to-severe primary restless legs syndrome (RLS). The medication has been approved to treat RLS and for the symptomatic treatment of idiopathic Parkinson's disease.
According to the FDA, reports have been received that patients treated with ropinirole have fallen asleep while engaged in daily activities, including driving, and some patients have reported being alert immediately prior to the episode, which occurred without warning.
Because it's not known whether reducing the dose of ropinirole will eliminate the problem, patients reporting significant daytime sleepiness during activities of daily living should be advised to discontinue ropinirole. Patients should also be questioned about potential exacerbating factors such as sleep disorders and use of other sedating medications or drugs that increase ropinirole blood levels.
Rapid flu test detects Avian Flu isolates
Becton, Dickinson and Co. Diagnostics' Directigen EZ Flu A + B has been approved by the FDA to allow differential diagnosis of influenza types A and B in 15 minutes or less from a single device. The two-step rapid chromatographic immunoassay has also been shown to be capable of detecting avian influenza H5N1 isolates.
The test can be stored at room temperature, is compatible with multiple transport media, and has been validated for use with multiple specimen types.
Although it uses nasopharyngeal washes/aspirates and throat swabs of symptomatic patients, commonly used oral medications such as throat drops, nasal sprays, and ibuprofen have shown no interference with test results in analytical studies.