Archive for the 'Drug Injury' Category

Prolonged use of Hormone Replacement Therapy may increase risk for breast cancer

marvinlundy August 11th, 2010

CNN (8/10, Willingham) “The Chart” blog reported, “Over the years, numerous studies have shown that hormone replacement therapy (HRT) increases a woman’s risk of developing breast cancer.” For many women, however, “questions about side effects, hormone combinations, and length of hormone use are still unanswered, causing confusion. And some continue to take hormones to relieve menopausal symptoms because they don’t know where they fall in the HRT spectrum. If you have been using Hormone Replacement Therapy and developed breast cancer tumors, you should talk to your attorney. Lundy Law will give you a free consultation.

Popularity: 12% [?]

Consumers sue J&J, demanding cash refunds for recalled children’s medicines

marvinlundy July 20th, 2010

Bloomberg News (7/9, Harris, Tirrell) reported that on July 8 in US District Court, Northern District of Illinois (Chicago), “Johnson & Johnson…was sued by US consumers accusing it of fraud and racketeering, and demanding cash refunds for recalled children’s cold and allergy medicines.” The five lawsuits “seek to proceed on behalf of plaintiffs’ groups for residents of Illinois, Texas, and Florida, as well as consumers in the US and Canada, who have bought the drugs since December 2008.”

Popularity: 13% [?]

FDA panel votes to keep Avandia on market with more restrictions

marvinlundy July 19th, 2010

ABC World News (7/14, story 5, 0:25, Sawyer) reported, “A surprise decision on Avandia [rosiglitazone]. Advisers to the Food and Drug Administration recommended keeping Avandia on the market,” although most “advisers did recommend stricter warning labels and the FDA will now decide which course to take.”
The New York Times (7/15, A1, Harris) reports on its front page that the 33 panelists “took six votes on a variety of issues” and when asked what the FDA should do, “12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.” Dr. Janet Woodcock, director of the FDA’s drug center, “said that the agency took the panel’s advice seriously and that it would consider its regulatory options.”

Popularity: 14% [?]

Two studies suggest diabetes drug Avandia increases risk of heart problems.

marvinlundy July 2nd, 2010

If you suffer from diabetes, you need to read this.

ABC World News (6/28, story 7, 2:20, Sawyer) reported, “Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems.”

The Washington Post (6/29, Stein) reports that one study, “involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack.” A separate study “of more than 227,500 Medicare patients — the largest such study to date — found that the drug boosts the risk for strokes, heart failure, and death.”
The Los Angeles Times (6/29, Roan) reports that the first study “found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine.”
Bloomberg News (6/29, Cortez) quotes Steven Nissen, MD, lead author of the study, as saying, “I think we’ve got more than enough evidence to say this drug should not be used.”
USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, “scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride].” The investigators found “no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death.”
Lawmakers call for Avandia to be pulled from market. &&&The Hill (6/28, Pecquet) “Healthwatch” blog reported that “Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday called for the diabetes drug Avandia to be pulled from the market in the wake of two new medical studies.” In a joint statement, Sen. Grassley said, “The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July.”
&&&Bloomberg News (6/29, Peterson, Cortez) reports that “Grassley and Senator Max Baucus, a Montana Democrat, in February released a report that said Glaxo knew Avandia may cause heart damage several years before” a “study documented the risk.”

Popularity: 12% [?]

FDA to institute stricter oversight of home medical devices

marvinlundy April 23rd, 2010

Bloomberg News (4/21, Olmos, Larkin) reports, “US regulators will strengthen their oversight of medical devices used at home as part of an initiative to improve safety of the increasingly popular products, according to information posted” on the FDA’s website. Notably, the “initiative will set new guidelines for home medical device manufacturers, training programs for patients and family members, and labeling and testing standards intended to address use of the devices such as heart monitors and kidney dialysis equipment.” The agency also said that “about 7.6 million people in the US receive healthcare at home from an estimated 17,000 home health companies.” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “Using complex medical devices at home carries unique challenges,” which “may pose environmental or safety hazards that can affect” how these devices function.

Popularity: 24% [?]

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