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Oral analgesic approved in extended-release form

Janssen Pharmaceuticals has received FDA approval for tapentadol extended-release (Nucynta ER) tablets for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Nucynta ER is a centrally acting synthetic opioid analgesic taken twice daily. It is classified as a Schedule II medication. Nucynta immediate-release was approved in 2008.


In clinical trials, Nucynta ER demonstrated efficacy for treating moderate-to-severe chronic pain in patients with chronic low-back pain and painful diabetic peripheral neuropathy. Safety evaluations in more than 1,100 patients with moderate-to-severe chronic pain over a 1-year period showed favorable tolerability profiles and favorable discontinuation rate.


Consult product labeling for prescribing directions and contraindications to treatment. The manufacturer has developed a Risk Evaluation and Mitigation Strategy for the medi cation in collaboration with the FDA to educate prescribers about the potential for abuse, misuse, overdose, and addiction from use of Nucynta ER.


Abnormal heart rhythms related to high-dose Celexa

The FDA issued a notification to healthcare providers and patients that the antidepressant citalopram (Celexa) should no longer be used at doses greater than 40 mg/day because it can cause prolongation of the QT interval and can lead to abnormal heart rhythm including Torsades de Pointes, which can be fatal.

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Citalopram should not be used in patients with congenital long QT syndrome. Patients with heart failure, bradydysrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs are at higher risk for developing Torsades de Pointes.


The drug's labeling has been changed to include the new drug dosage and usage recommendations.


Kidney failure risk added to Reclast label

The FDA notified healthcare practitioners and patients that the drug labeling of zoledronic acid (Reclast) has been up dated to add a new contraindication and warning about kidney failure. The agency stated that cases of acute renal failure requiring dialysis or resulting in fatality following Reclast use have been reported.


Revised labeling states that Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. The labeling also recommends that patients be screened prior to administration of Reclast to identify those who are at risk.


The drug's Medication Guide is being updated to include information about the risk of severe kidney problems.


Labeling changes are being made only to the Reclast labeling, although zoledronic acid (also sold as Zometa) is approved for the treatment of cancer-related conditions. Renal impairment is already addressed in Zometa's labeling.


Botox approved for some types of overactive bladder

The FDA has approved Allergan's botulinum toxin type A (Botox) for treating urinary incontinence due to overactive bladder in patients with spinal cord injuries or multiple sclerosis who are intolerant or have inadequate response to anticholinergic medication. The approval allows injection of Botox into the bladder via cytoscopy, which may require general anesthesia.

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According to the FDA, Botox works by relaxing muscle, increasing storage capacity, and reducing incontinence. The treatment's benefits should last app roximately 9 months. However, there must be a minimum of 12 weeks between the initial injection and a repeat bladder injection.


Approval for this was based on data from clinical studies that showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox versus placebo group.


The most common adverse events reported in clinical trials were urinary tract infections and urinary retention. Consult the complete product labeling for warnings and precautions associated with the drug including dysphagia and breathing difficulty.