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Weekly News Round Up - January 11, 2012

Subsys Approved Under Restricted Access Program

Subsys (fentanyl sublingual spray) approved for breakthrough cancer pain; only available under restricted access program Read More...

Breakthrough cancer pain results in sudden, intense pain episodes that occur even though the patient is receiving continuous pain relief medication. Subsys (fentanyl sublingual spray) is now approved specifically for adult cancer patients with breakthrough pain who are opioid-tolerant and currently receiving around-the-clock opioid therapy. Subsys use is contraindicated in acute or post-operative pain, as fatal respiratory depression and death may occur in opioid non-tolerant patients. Combined use of moderate or strong CYP450 3A4 inhibitors can result in a drug interaction that may warrant a Subsys dose reduction to prevent severe respiratory depression. Use, prescribing, distribution and dispensing of Subsys requires enrollment in the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access Program.

Opiate Pain Medication Mix-Up Warrants a Second Look

Tablet mix-up during opiate packaging may have resulted in stray tablet ending up in wrong bottle Read More...

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers to examine any bottles of opiate pain medications made by Endo Pharmaceuticals to ensure all of the tablets are the same. The opiates affected include: Opana ER, Opana, oxymorphone HCL, Percocet, Percodan, Endocet, Endodan, morphine sulfate ER, and Zydone. Novartis Consumer Health packaged the products for Endo at its Lincoln, Nebraska facility. Problems with packaging and labeling may have resulted in stray tablets being carried from one product type to the bottle of another product type. Only pharmacists have detected the mix-ups; there have been no patient-confirmed mix-ups or adverse events. There may be short-term supply disruptions of Opana ER and other Endo products due to a temporary shut down of the Novartis plant.

OTC Product Recalls: Excedrin, Bufferin, Gas-X Prevention, NoDoz

Voluntary recall for Excedrin, Bufferin, Gas-X Prevention, and NoDoz due to chipped or erroneous tablets, gelcaps found in bottle Read More...

Novartis Consumer Health Inc. is voluntarily recalling all lots of Excedrin, Bufferin, Gas-X Prevention, and NoDoz due to reports of chipped or broken tablets and gelcaps, and inaccurate packaging resulting in bottles that may contain the incorrect medication. The FDA recommends that consumers in possession of these products look closely at the pills, and if any product has a different shape, size, color or marking, they should bring the bottle back to a pharmacist and not take any more of that medication. Consumers can also contact Novartis for return of the affected medication.

Doribax Clinical Trial Halted Due to Safety Concerns

Doribax (doripenem) trial in ventilator-associated pneumonia indicates excess mortality; Doribax still safe for current approved indications Read More...

The U.S. Food and Drug Administration (FDA) is notifying the public that a clinical trial with Doribax (doripenem) in ventilator-associated pneumonia has been associated with excess mortality and a lower clinical cure rate than treatment with imipenem-cilastatin. Doribax is not currently approved for any type of pneumonia, but it remains safe and effective for approved indications of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis. Doses should not exceed 500 mg every eight hours given intravenously over one hour. Treatment duration, ranging from 5-14 days, is dependent upon indication.

Excess Vitamin D May Be Associated With Increased Heart Risk

Study suggests that c-reactive protein may rise if vitamin D levels are on the low end of normal Read More...

Vitamin D is often recommended to maintain normal bone and heart health. But a recent study from the John Hopkins School of Medicine suggests that if vitamin D levels rise even slightly above the low end of normal, the beneficial heart effect from vitamin D may be reversed. In a 5-year study in over 15,000 adults, levels of c-reactive protein, an inflammatory marker for the heart and blood vessels, rose when vitamin D levels went beyond normal. Researchers emphasize that people need to be aware of the possibility of toxic effects even with over-the-counter vitamin supplements. Patients should check with their health care provider and have vitamin D blood levels measured before taking a vitamin D supplement.