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VA 59 articles

Heart device may eliminate need for heparin, warfarin

A small device implanted in the heart to stop blood clots from triggering strokes could serve as an alternative to blood thinners such as heparin and warfarin, according to a new study conducted by the device’s maker, Atritech, Inc. The device, called the Watchman, is designed specifically for patients with atrial fibrillation, a type of irregular heartbeat. Blood tends to pool in the atrial chamber of individuals with atrial fibrillation, which can lead to clotting and an increased risk for strokes. Patients with atrial fibrillation are generally treated with blood thinners to help prevent blood clots from forming. However, blood ... Read More

Lawmakers debate safety of importing drugs

Congress continues to debate the notion of allowing people to buy inexpensive drug from other countries, as the Obama administration is encouraging, but the stickler seems to be ensuring the safety of those imported drugs, according to Portfolio. Even on the campaign trail, Obama’s camp said it would support the plan but that there would have to be measures in place to ensure the FDA was properly inspecting the plants where drugs are being manufactured. After all, it was just one year ago that hundreds of people became ill and more than 80 died after receiving injections of the blood ... Read More

New budget supports plan for importation of drugs

As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the FDA beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (FDA’s) efforts to allow Americans to buy safe and effective drugs from other countries.” However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health ... Read More

Chantix sales fall, Pfizer fires ad agency

It looks like there is another ominous blip in the Chantix radar. Pfizer decided to ditch the ad agency it has been using for its Chantix advertisements. The announcement comes after the company announced the smoking cessation drug’s fourth quarter earnings, which fell 36 percent from the same time last year to $180 million. Promoting the embattled and controversial drug will now be the responsibility of mcgarrybowen, which is a subsidiary of the Japanese ad giant Dentsu. Pfizer had been using McCann HumanCare to promote Chantix since 2007. Since that time, the drug has been linked to depression, suicide ideation, moodiness, ... Read More

More Canadians harmed by Chantix as government revises warnings

Health Canada has received 818 reports of adverse side effects caused by the smoking cessation drug Chantix (marketed in Canada and elsewhere as Champix) since it first became available to Canadians nearly two years ago. The majority of complaints concerned psychiatric problems. Chantix is known to cause or exacerbate a spectrum of psychiatric and physical reactions, including moodiness, depression, violent behavior, lack of sleep, blackouts, and suicidal thought and actions. Last month we reported that Health Canada was preparing to strengthen warnings on Chantix labels. However, Health Canada still has not taken action. In a report by the Canadian Broadcasting Corporation, Health ... Read More

Heparin producer's insurers file lawsuit

The insurance companies for Scientific Protein Laboratories’ parent company, American Capital Ltd., are suing to nullify the policies with the laboratory, according to The Daily Record. The Wisconsin-based company entered a joint venture with Baxter International Inc. to produce heparin in China. Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a heparin-mimicking material that can cause life-threatening allergic reactions. The contaminated heparin killed more than 80 people in the U.S. and sickened hundreds more before several batches of the blood thinner were recalled. American Capital purchased 87 percent of Scientific ... Read More

FDA scientists say their agency is corrupt and broken

A group of scientists at the Food and Drug Administration has sent a letter to President-elect Obama and his transition team, urging a clean-up of the government agency. The letter says that widespread mismanagement and incompetence in the agency have “placed the American public at risk.” The six-page letter alleges that FDA managers “have ordered, intimidated and coerced scientists to manipulate data in violation of the law,” according to a report in the Wall Street Journal. “The scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at ... Read More

Torti named interim commissioner of FDA

FDA chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News. Dr. Torti joined the FDA in May, just as the tainted heparin scandal was still brewing at the agency. Dr. Von Eschenbach recruited Dr. Torti to “help bolster the agency’s scientific infrastructure,” according to the news story. Last year more than 80 Americans died and hundreds more became ill ... Read More

Lawmaker opens investigation into 'software glitches' at VA

Software “glitches” that lead to medical mishaps and prolonged infusions of drugs such as heparin administered to patients at Veterans Affairs hospitals throughout the U.S., which was reported by the Associated Press earlier this week, have raised concerns from the chairman of the House Veterans Affairs Committee, according to a new report by AP. Nearly one-third of the country’s 153 VA hospitals reported problems with the electronic medical records. Calling the findings a sign of “dangerous lack of accountability,” Rep. Bob Filner said he would investigate the matter that put the safety of VA patients risk. “VA continues to discover ... Read More

CDC study provides details on OSCS-laced heparin

The New England Journal of Medicine reported that the Centers for Disease Control and Prevention (CDC) in a study titled “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” has confirmed the cause of serious adverse reactions in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, the CDC also determined that the contaminated heparin was linked to 152 adverse reactions in 113 patients from 13 states from Nov. 19, 2007 through Jan. 31, 2008. The study also reported, “the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions ... Read More