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Weekly Drug News Round Up - September 11, 2013

FDA Strengthens Warnings for Long-Acting Opioids

New labeling will include updates to indications, box warnings, medication guide, and more Read More...

The U.S. Food and Drug Administration (FDA) has updated prescription opioid labeling in an effort to curtail abuse and addiction of potent extended-release and long-acting narcotic painkillers such as Oxycontin (oxycodone), Exalgo (hydromorphone) and MS Contin (morphine). The updates cover the entire class of extended-release and long-acting (ER/LA) opioid analgesics. In addition, the FDA is requiring manufacturers to conduct post-marketing safety studies to assess the risks of these potent painkillers. The indications section clarifies that ER/LA opioids are to be used only for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Motrin Infants’ Drops Recalled Due to Plastic Particles

The recalled products may contain tiny bits of PTFE, which is a plastic used in Teflon coatings Read More...

Johnson and Johnson’s McNeil unit has recalled roughly 200,000 bottles of Concentrated Motrin Infants’ Drops Original Berry Flavor One-Half Fluid Ounce due to a possible plastic particle contamination. The lot numbers of the recalled half-ounce bottles are DCB3T01, DDB4R01 and DDB4S01. Retailers were asked to remove the lots from shelves and consumers should stop using the products. Motrin (ibuprofen) is the popular nonprescription NSAID pain and fever reliever commonly used in children; the infant formulation is used in children two years and younger. No illnesses or injuries have been reported to date, according to the company. Consumers can call McNeil for a refund at 1-877-414-7709.

Celgene’s Abraxane Approved for Late-Stage Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the U.S; in 2013 over 38,000 people will die from the disease Read More...

The U.S. Food and Drug Administration (FDA) has approved Abraxane (paclitaxel protein-bound) to be used in the treatment of late-stage (metastatic) pancreatic cancer. Abraxane, a taxane chemotherapeutic drug, is also approved for the treatment of advanced breast and lung cancer. Abraxane is used with gemcitabine (Gemzar), another chemotherapy drug, in patients with metastatic pancreatic cancer. In clinical trials, patients who were treated with Abraxane plus gemcitabine experienced a delay in tumor growth for an average of 1.8 months and lived, on average, 1.8 months longer than those treated with gemcitabine alone.

How Safe is Marijuana?

Researchers question marijuana “safety”; about 1 in 4 teens will become dependent upon the drug Read More…

Researchers have found that marijuana can be harmful for teenagers, since it affects the addiction processes in their developing brains. Marijuana’s popularity is due in part to its perception as being a “safe” drug, compared to drugs like cocaine, heroin, or designer drugs like bath salts. Marijuana interacts with brain chemical receptors responsible for reward learning, motivated behavior, and habit formation, among others. Researchers note that those who develop a marijuana dependence may have a personality characterized by negative affect, aggression and impulsivity from an early age. Identifying those teens that may be at higher risk of marijuana dependence may help to lower their risk for these traits.

Botox Cosmetic Approved to Improve the Appearance of Crow’s Feet Lines

Botox Cosmetic is the only approved treatment for crow’s feet, also known as lateral canthal lines Read More…

Botox Cosmetic (onabotulinumtoxinA), the popular injectable treatment used to smooth wrinkles between the eyebrows (frown lines), has been approved by the U.S. Food and Drug Administration (FDA) to treat crow’s feet in adults, medically known as lateral canthal lines. In clinical trials, 833 subjects with moderate to severe lateral canthal lines had greater improvement in their appearance of “crow’s feet” around the eyes compared to placebo. The most common side effect was eyelid edema, a condition in which the eyelids are swollen and contain excessive fluid. Treatment for both frown lines and crow’s feet can be given at the same time.