A doctor in Maryland has claimed that the maker of Avandia tried to shut her up when she criticized the controversial drug.  Dr. Mary Money, a Hagerstown internist, recently spoke with the  The Wall Street Journal about her experience with Glaxo after she and a colleague voiced concerns about Avandia in 2000

According to Dr. Money, she and another doctor, Stephen Lippman, at Washington County Hospital in Hagerstown, met with representatives of SmithKlineBeecham, and presented data on 85 of their  Avandia patients.  According to The Wall Street Journal, more than half of the patients had significant edema, or swelling, and about half of that group also had high pulmonary pressure and shortness of breath. Three had been hospitalized for congestive heart failure. (more…)

Johnson & Johnson has lost another Duragesic Pain Patch lawsuit, with an jury blaming the fentanyl patch for the 2004 death of an Illinois woman.  According to Bloomberg.com, this is the fourth Duragesic case that Johnson & Johnson has lost in the past two years.  Last month, a Florida jury awarded more than $13 million to the family of a 34-year-old woman who died after using a Duragesic patch in 2002.

According to the Associated Press, 38-year-old Jerry DiCosolo died in 2004 while using a Duragesic Pain Patch to treat pain she suffered as a result of a neurological problem.  The lawsuit filed by DiCosolo’s family claimed that Johnson & Johnson subsidiaries, Janssen Pharamceutica and ALZA Corp.,  knew about problems with the Duragesic patch that allowed it to leak fentanyl in doses large enough to kill patients. (more…)

Medtronic Inc. is facing a probe over off-label use for it its Infuse Bone Graft.  According to the Dow Jones Newswire,  the company’s CEO According to the Dow Jones Newswire, Medtronic revealed the Justice Department’s Infuse subpoena during a conference call with investors this morning.

CEO Bill Hawkins said during the call that the company is complying with the Justice Department’s request, but insisted that Medtronic was not promoting off-label use of Infuse.  Hawkins said that if doctors were using the bone graft product in off-label procedures, it was because they had determined it “was the best therapy for their patients.” (more…)

 The U.S. Justice Department has filed suit to shut down three substandard Actavis Totowa facilities in New Jersey.  The lawsuit follows recalls of defective generic drugs, including oversized Digitek tablets, made by Actavis earlier this year. The Justice Deparment is seeking a permanent injunction to bar Actavis Totowa and Actavis Inc, as well as  two of their officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act.

According the Justice Department lawsuit, the  FDA conducted five inspections of  three Actavis facilities in  Totowa and Little Falls, New Jersey over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of Good Manufacturing Practice requirements. The FDA also found that the company continued to manufacturer and distribute unapproved new drug products, the complaint says. (more…)

Children treated with the anti-fungal drug Lamisil have experienced side effects including skin reactions, neurological problems and psychiatric problems, according to a new report written by Food & Drug Administration (FDA) staff.  The report recommends that Lamisil be be monitored for side effects in children.  An FDA advisory panel is scheduled to take up the issue of Lamisil side effects today.

According to the FDA staff report, 47 postmarketing reports of  adverse events associated with pediatric use of Lamisil were submitted to the FDA since approval through January 4, 2008. Of all the pediatric side effects reported to the FDA, none resulted in deaths. However, six of 47 cases reported hospitalization, life-threatening, and/or disability outcome; these six cases included four cases of skin reactions, and one case each of leg pain and thrombocytopenia/anemia. The remaining 41 cases were considered serious because the reporter considered the event to be medically significant. (more…)

The Food & Drug Administration (FDA) has scheduled an advisory panel meeting for Tuesday to discuss problems with wrinkle fillers like Juvederm and Restylane. Known as dermal Fillers, these injectable substances used to restore or enhance fullness to the lips or to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. While dermal fillers are approved for the treatment of moderate to severe facial wrinkles, the FDA said that they are increasingly being used to augment and contour tissues.

In the report released today, the FDA said it expects to receive more applications to sell dermal fillers for wrinkles and possibly for contouring the face and body. As a result, the agency said it wants to determine whether improvements are needed in the way the products are studied and labeled. (more…)

An  National Transportation Safety Board (NTSB) investigation into last year’s deadly Minneapolis Bridge collapse has blamed the disaster on gusset plates that were too thin to carry the loads the structure was subjected to. As a result, the I 35 West bridge to collapse under the weight of construction equipment that had been sitting on the structure at the time of the disaster.

Gusset plates act like braces to hold bridge joints together.  Deck truss bridges, like the I-35 W Bridge that collapsed, are especially vulnerable if gusset plates fail. That type of bridge design has no back up features to prevent a collapse if one component of the structure fails. For that reason, bridges like the 40-year-old Minneapolis Bridge are rarely built today. (more…)

More trouble for Avandia, as a new study finds it isn’t much better at reducing plaque buildup in the arteries than an older, generic diabetes drug. The results of this new Avandia clinical trial, released yesterday at the American Heart Association Meeting in New Orleans, has once again raised questions about the expensive diabete’s drugs usefulness.

Avandia’s been in trouble since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, the Food & Drug Administration (FDA) finally ordered that a black box warning detailing Avandia’s heart related risk be added to the drug’s labeling. (more…)

Victoria’s Secret bra have been linked to painful rashes and other skin problems, prompting the filing of a potential class action lawsuit.

Roberta Ritter, 37, of Ohio claims that after she wore her new Angels Secret Embrace and Very Sexy Extreme Me Push-Up bras, she suffered from a rash that was “red hot to the touch, burning and itching.”  (more…)

Stent patients who take Plavix along with heartburn drugs known as proton pump inhibitors may have a higher risk of heart attack and stroke, according to a new study.

According to The Wall Street Journal, a article published  in the journal Circulation in 2003 showed that nearly 30 percent of Plavix patients don’t process the drug effectively.  This new study could be an important clue as to why.  People on Plavix are often prescribed proton pump  inhibitors, such as Nexium, Protonix and Prevacid, because Plavix has been linked to a higher risk of ulcers. (more…)