Alpharma gets FDA approval for Flector patch
BRIDGEWATER, N.J. Alpharma Pharmaceuticals has received approval from the Food and Drug Administration for its Flector patch 1.3 percent, which is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
The drug will be used to replace traditional oral anti-inflammatory medications. “The main drawback of commonly used oral anti-inflammatory medications is that many people cannot tolerate them,” said Robert Sheu, director of the Pain Division in the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, New York. “There are a lot of physicians and patients who would prefer a more targeted approach to treating pain at the site of an injury, and a topical patch accomplishes this while avoiding the stomach and digestive tract.”
Studies have shown that up to 50 percent of patients who suffer from pain have intolerance to traditional oral anti-inflammatory drugs.
The drug is recommended to be applied twice daily, on the most painful area and not to be worn for more than 12 hours per day. The patch contains 180 mg of diclofenac epolamine. The drug is the first and only prescription anti-inflammatory pain relief patch in the U.S. The company will start marketing the drug immediately.
FDA updates labeling for birth control patch to reflect risk of blood clots
WASHINGTON The Food and Drug Administration has approved additional changes to the labeling for the Ortho Evra patch, made by Ortho McNeil Pharmaceuticals, to include the results of a new study that found users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism, which can lead to a pulmonary embolism.
The Boston Collaborative Drug Surveillance Program on behalf of Johnson & Johnson conducted the study. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.
Ortho Evra is a prescription patch that releases the hormones ethinyl estradiol and norelgestromin through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including VTE.
Women should discuss with their health care providers the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.
Study shows Avodart/Flomax combo more effective on enlarged prostate problems
PHILADELPHIA A new study that will be published in the Journal of Urology shows that men with enlarged prostates who took a combination of two medications, Avodart and tamsulosin hydrochloride, the generic version of the Astellas Pharma/Boehringer Ingelheim drug Flomax, experienced greater improvements in urinary symptoms than men prescribed either medication alone, according to published reports.
Over time, Avodart (dutasteride) shrinks the prostate, improves symptoms and arrests the enlarged prostate disease process. Tamsulosin is an alpha-blocker that relaxes the muscles in the bladder and prostate.
The study, entitled The Combination of Avodart and Tamsulosin, looked at male patients with moderate-to-severe enlarged prostate symptoms received a placebo for four weeks and then were randomized to receive Avodart and tamsulosin as combination therapy, for the remaining 24 months of the study.