Chantix or Varenicline Tartrate as it is also known is a prescription medicine prescribed for smoking cessation. Chantix, unlike similar drugs in the past, does not contain nicotine. Instead of slowly lessening the nicotine levels in one’s body, Chantix attempts to reduce and ultimately eliminate cravings of those individuals taking it.

Since its FDA approval in May 2006, there have been hundreds of reports of serious psychiatric complications including agitation, suicidal behavior and/or successful suicide, depression and increased aggression levels in patients taking the drug.  These symptoms were linked but not limited to patients who suffered pre-existing mental conditions.

Pfizer, the drug manufacturer, maintains the position and opinion that the severe changes in mood and erratic behavior in Chantix users is due to the withdrawal of nicotine from the body. The FDA’s findings indicate that even those patients who had continued smoking had similar psychiatric episodes and that it is “increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms”.

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The State of Iowa will receive $1.3 million dollars from pharmaceutical giant Merck for false and risky marketing of the pain relief drug Vioxx. Though Vioxx has been off the market since 2004, Merck is only just now beginning to face the real consequences of their actions. The $1.3 million settlement is part of a larger $58 million nationwide settlement.
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A drug that was put on suspension after being linked with thousands of deaths is finally being pulled from the shelves. Earlier this week, Bayer HealthCare Pharmaceuticals Inc. announced to the FDA and consumer groups that it plans to recover any Trasylol that is still left in the market.

Trasylol is a drug used to control bleeding during heart surgery. But last year, a Canadian study linked Trasylol to kidney problems, heart attacks, and strokes that can cause death. The company says that most remaining Trasylol is in storage or in doctors’ offices. Trasylol had been marketed aggressively by Bayer before it was finally taken off the market last fall.

In fact, part of what caused the drug to be removed in October was the previously mentioned Canadian study. The study was actually suspended in the middle of research because it became clear that patients taking Trasylol were at an increased risk for death.

While Bayer is taking Trasylol back, it will still be allowed for a limited number of patients who have no options for safe alternative treatments because of their specific conditions. However, doctors will have to document that the risk of not taking Trasylol is greater than the risk the drug itself presents.

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Today, drug giant Merck found favor in a Texas appeals court. The court reversed a decision finding Merck at fault for the death of a 71-year-old man who took VIOXX. His widow would have received almost $8 million (down from $32 million) in damages and punitive damages. (more…)

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Doctors need to be reminding their patients about possible confusion with asthma medication, which could put people’s health in danger. The agency says that the asthma medications Spiriva and Foradil both have the potential to be administered incorrectly. While the mistake does not do direct harm to the person as a result of ingesting the drugs, it also does not help their respiratory condition as the medications are intended to do.
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An antibody used to help patients with relapsing multiple sclerosis may cause serious liver injury that leads to death, according to a safety alert from the FDA. Tysabri us manufactured by Biogen Idec and Elan Pharmaceuticals. These companies, along with the FDA, are sending letters to health care professionals to warn them of the drug’s potentially deadly consequences.
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For the first time since heparin was recalled, those who lost loved ones to the dialysis drug testified before Congress earlier this week. A House subcommittee heard from families of some of the more than 80 people who died because of the tainted drug. They told stories of painful and irreversible decline in just a course of hours.

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In April, a major medical journal disclosed that drug giant Merck actually conducted its own studies on the drug Vioxx, then paid medical doctors to add their bylines to the studies. Vioxx was removed from the market in 2004 after 5 years because it put people at risk for potentially life-threatening heart problems and other complications.

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On December 29, 1993, Trasylol (aprotinin injection) was approved by the FDA as an effective drug for controlling bleeding during heart surgery. Despite growing evidence that Trasylol significantly increased the risk of kidney failure, heart attack, stroke, and death, Bayer Pharmaceutical marketed Trasylol aggressively until it was taken off the market in November of 2007.

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