Tagged Articles

Food and Drug Administration 233 articles

FDA makes blunder during hiring of PR firm to improve image

Every company can use a good spin doctor from time to time, and it looks like the Food and Drug Administration (FDA) is no exception. Last month I told you that California Rep. Harry Waxman, who serves as head of the House Oversight and Government Reform Committee, raised concerns that items outlined on the FDA’s 2007 priorities list appeared to prioritize industry desires over consumer protection. This, just months after more than 80 American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. FDA officials later acknowledged they had not inspected that facility ... Read More

Type 2 diabetes drug Avandia linked to osteoporosis and bone loss

Researchers believe that the diabetes drug Avandia may cause bone loss and long-term use may speed up osteoporosis. The thinning of the bones is dangerous and could lead to fatal fractures. The study published in the December 2nd issue of Nature Medicine suggests that usage of rosiglitazone in the treatment of type II diabetes may cause osteoporosis. The maker of the drug, GlaxoSmithKline (GSK), disputes the osteoporosis finding. The company said in a statement today that their ADOPT studies showed no increase in spine or hip fractures which are associated with osteoporosis. The company says they will be looking further ... Read More

French Lovenox brand heparin recall

There has been yet another report of heparin being pulled off the market for fear it may harm people. This week, French drug maker Sanofi-Aventis recalled the remaining batches of its heparin medicine distributed before May 2008, Lovenox, based on a recommendation by French drug regulator Afssaps. Lovenox, the company’s number one selling medicine, was first recalled last June after some batches of its pre-filled injectible solution were found to be contaminated with trace amounts of oversulphated chondroitin sulphate, according to Reuters. Oversulphated chondroitin sulphate is the same contaminate found last March by the Food and Drug Administration (FDA) in batches ... Read More

Chantix ads back on television

Next week, Pfizer will once again be running Chantix ads on television. Pfizer stopped running Chantix ads last year amid increasing concern over the drug’s side effects. The familiar tortoise and the hare ads will resume on Sunday, September 14, with lengthened warnings about potential side effects. The extended warnings will occupy 41 seconds of the ad, which will run for 90 seconds – 30 seconds longer than the old ads. According to an article in Forbes magazine, Chantix is in line to become Pfizer’s vital cash cow as patent protection for some of the company’s successful older medications expires. ... Read More

Lawmaker questions FDA priorities, suggests industry ties

Tainted batches of heparin may have raised concerns with the general public, but a recent Reuters report suggests the U.S. Food and Drug Administration (FDA) would rather focus on giving product promotion advice to companies and journal reprints to physicians than food and drug safety scares. The FDA also planned to change its regulations to protect device makers’ FDA-approved products from lawsuits with a so-called preemptive clause, according to Reuters. The news agency says that in a letter from California Rep. Henry Waxman, to FDA Commissioner Andrew von Eschenbach, Waxman raised concerns that the items outlined on the FDA’s 2007 priorities ... Read More

Doctors support drug litigation

Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday. Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain ... Read More

Pharmacists will call: Digitek recalled

A generic form of digitalis – a heart drug – has been recalled in an unusual action that requires pharmacists to personally notify all customers who have purchased it. Doctors prescribe the drug, Digitek, to treat heart failure and abnormal heart rhythms. Actavis Totowa, a Totowa, N.J., manufacturer, recalled Digitek after consulting with the Food and Drug Administration. Actavis makes Digitek for Mylan Pharmaceuticals of Pittsburg, Pa. Actavis counsel John LaRocca said the company recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. An FDA statement said: “These tablets may contain twice ... Read More

Heparin Linked to Severe Allergic Reactions

FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high “bolus” doses of the drug. Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is ... Read More

Senators Obama and Cornyn question VA over Chantix tests

Yesterday, ABC News and The Washington Times broke a story about Iraq and Afghanistan veterans with Post Traumatic Stress Disorder (PTSD) receiving Chantix as part of a study conducted by the Veterans Administration. Today ABC reports that Senators Barack Obama (D-IL) and John Cornyn (R-TX) are demanding an investigation. In the study, the VA gave 140 US soldiers with PTSD Chantix, not revealing to them that the drug had been linked to a number of physical and psychological side effects, including anxiety, nervousness, tension, depression, suicidal thoughts, attempted suicide, and actualized suicide. The Food and Drug Administration issued Chantix warnings ... Read More

VA testing Chantix on veterans with Post Traumatic Stress

Today, ABC News and The Washington Times uncovered a story that, if proven true, exposes some enormously unethical conduct in our nation’s leadership. According to the news organizations, the Veterans Administration chose to administer Chantix to 140 Iraq and Afghanistan veterans who have been diagnosed with Post Traumatic Stress Disorder (PTSD), ignoring Food and Drug Administration warnings that the drug has been linked to vivid dreams, psychiatric illnesses, and suicide, to name just a handful of the drug’s potential adverse effects. The VA waited more than three months before it began notifying the veterans of the dangers of Chantix. Even then, ... Read More