January 5th, 2009 meg
Study researchers and colleagues say Fosamax and other bisphosphonate drugs may be riskier than previously thought.
After having teeth pulled, 4% of patients in a study who were taking Fosamax developed a dangerous condition called osteonecrosis of the jaw. None of the tooth extraction patients not taking Fosamax developed osteonecrosis.
Osteonecrosis of the jaw, sometimes called jawbone […]
January 2nd, 2009 meg
Ortho-McNeil-Janssen Pharmaceuticals, Inc. has issued a voluntary recall of Duragesic CII patches sold by their PriCara division. They are also recalling one lot of patches sold by Sandoz Inc.
The patches may have a cut along one side of the drug reservoir, possibly leaking fentanyl gel, exposing patients or caregivers directly to fentanyl gel.
The patches are […]
January 2nd, 2009 meg
A Food and Drug Administration (FDA) official has reported that Merck’s popular osteoporosis drug Fosamax and other similar drugs may carry a risk for esophageal cancer.
Since Fosamax, known generically as alendronate, was introduced in 1995, the FDA has received 23 reports in which patients developed esophageal tumors. There are 21 additional cases in Europe and […]
January 2nd, 2009 joshua
Biovail Corp. has issued a voluntary recall on certain lots of its chronic pain medication Ultram.
According to Reuters, the lots of Ultram were out-of-specification by about one percent with respect to maximum dissolution at the eight-hour mark, according to a report from Reuters.
Biovail, the leading Canadian drug maker, said the voluntary recall will cost the […]
December 31st, 2008 meg
The Federal Health and Ageing Department in Australia have revealed that use of a cosmetic treatment has resulted in birth defects.
The mother was given Dysport in her first week of pregnancy.
The baby was born deaf and blind.
Dysport, Myobloc and Botox are botulinum type A toxin drugs used as cosmetic treatments.
U.S. Food and Drug Administration […]
December 31st, 2008 joshua
The Food and Drug Administration has approved the gadolinium-based Vasovist injection for use in patients about to undergo a magnetic resonance angiography, which scans blood vessels.
The active ingredient in Vasovist is gadolinium, a metal mined from the earth, making this a gadolinium contrast agent. The FDA said it looked at the drug in two clinical […]
December 30th, 2008 meg
Federal regulators have agreed to a Consent Decree with Icelandic drugmaker Actavis in which the company will temporarily cease production of generic drugs at its New Jersey manufacturing plants.
The U.S. Justice Department filed a complaint against the company last month for not complying with Food & Drug Administration (FDA) good manufacturing standards.
Actavis announced a voluntary […]
December 30th, 2008 joshua
A Harvard researcher says he’s fighting to clear his name in a conflict-of-interest dispute with the maker of an anti-aging supplement.
Shaklee, makers of the anti-aging supplement Vivix, say they had every right to use the name of Harvard University professor David Sinclair to endorse their product. Sinclair denies this deal was ever in place.
The Wall […]
December 26th, 2008 meg
Nearly one in 25 older Americans are at risk for serious health problems such as bleeding and muscle weakness because they take an unwise combination of drugs.
Half the time, a non-prescription medication is involved.
The most commonly used prescription or over-the-counter medications were taken to treat heart disease and range from aspirin to blood thinners to […]
December 24th, 2008 meg
Federal regulators warned Abbott Laboratories over an advertisement for the psoriasis drug Humira, saying it is misleading and makes claims not supported by scientific evidence.
The ad for Humira suggests the drug is approved for any patient with moderate to severe chronic plaque psoriasis. Humira is only approved for a more limited patient population.
The ad […]
