Friday, 13 November 2009

It has come to our attention that an electronic cigarette company is conducting a scam. They are "giving away" an electronic cigarette known as the e-igarette. Before doing so, they ask for customers card details. After the e-igarette has been sent, they start charging the customer for refills. The amount of money taken can be up to 80 pounds a month, and according to our last caller the cartidges never arrived. As a debit card rather than a credit card was used in each instance, the banks have refused to refund the money.

Continued on the Ashtray Blog Site

Chantix (varenicline) Tablets

FDA Approved Smoking Cessation Drug blamed for 3,063
serious injuries and 78 deaths

RESULTS

Table 3 describes the 3063 reports included in this analysis. The FDA defines a serious adverse event as one that results in death, disability, a birth defect, hospitalization (initial or prolonged), is life threatening or requires intervention to prevent harm.    The agency also allows an “other serious” category that might include events such as skin cancer or cardiac rhythm disturbances that did not result in hospitalization.

The patients characteristics show those experiencing serious injury were predominantly female (69%) and  median  age was 50.  Compared to our previously published assessment of all reports to the agency over an 8-year period, the varenicline reports have a greater share of  reports from females (69% vs 55%), from consumers (57.3% vs 25.9%), and a substantially lower proportion of reported deaths (2.5% vs 17% ).Varenicline also had a smaller proportion of reports submitted directly to the FDA (8% vs 19%) probably because of problems with the classification of “other serious” adverse events.

Recommendations

We have immediate safety concerns about the use of varenicline among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury.  Other examples include persons operating nuclear power reactors, high-rise construction cranes or life-sustaining medical devices.   Based on reports of sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia and psychosis, we believe varenicline may not be safe to use in these settings.   The extent to which varenicline has already contributed to accidental death and injury has not yet been investigated because these adverse effects had not been previously reported.   The Federal Aviation Administration approved varenicline for use by airline pilots³  before most of these reports were available.

In addition, we recommend that patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation.

Finally, we urge the FDA and the manufacturer to provide warnings to doctors and patients for those adverse effects that can be adequately documented through existing data, and to undertake on a priority basis epidemiological studies or other research to assess other potential risks.  We promptly notified the FDA of our findings.

Monday, July 27, 2009

Potent Carcinogens (Tobacco-Specific Nitrosamines) Found in Saliva of Nicotine Gum Users; When Will FDA Take Enforcement Action Against Nicorette?

FDA NEWS RELEASE

FDA Approves Novel Medication for Smoking Cessation

The U.S. Food and Drug Administration (FDA) announced today the approval of Chantix (varenicline tartrate) tablets, to help cigarette smokers stop smoking. The active ingredient in Chantix, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.

Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking.

A study released today examined 6,363 U.S. Food and Drug Administration (FDA) adverse drug reaction reports implicating Pfizer's quit smoking pill Chantix (varenicline) and found that 3,063 involved serious injuries. Its recommendation? "We recommend that patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation."

Authored by The Institute for Safe Medication Practices (ISMP), a non-profit medication watchdog, ISMP looks for safety flags while monitoring all adverse events reported to the FDA for all medications.

ISMP monitoring noted that "by the 3rd quarter of 2007 varenicline produced a signal not previously seen for any other drug. It produced more serious reports than any other drug for multiple types of events: more potential cases of angioedema, cardiac arrhythmia, diabetes and severe cutaneous injury. By the 4th quarter of 2007 varenicline accounted for more reports of serious drug adverse events in the United States than any other drug."

During the 4^th quarter of 2007 the FDA received 998 reports of serious varenicline adverse events compared to only 372 for the addictive troublemaker oxycodone, a potent medication for relief of moderate to severe pain. While ISMP estimates that a total of 3.5 million Chantix (varenicline) prescriptions were written in the U.S. since FDA approval in May 2006, government estimates place annual oxycodone prescriptions written at more than 7 million.

The study found that while the FDA has issued warnings regarding Chantix's link to suicidal acts, thoughts or behaviors, psychosis, hostility and aggression, it has ignored "other kinds of serious harm for which no warnings now exist, either from the FDA or from the manufacturer, Pfizer Inc."

While the FDA received 78 death reports in which "varenicline was the principal suspect drug," only 28 resulted from suicide. There were "numerous reports suggesting cardiac causes, both thromboembolic and arrhythmic," writes ISMP.

Among reports of serious events were 173 accidents and injuries, 338 angioedemas, 224 cardiac arrhythmias, 86 convulsions, 139 embolic and thrombotic events, 372 extrapyramidal syndromes, 544 cases of hyperglycemia/new onset diabetes mellitus, 525 reports of hostility/aggression, 397 psychosis and psychotic disorders, 227 reports of suicide/self-injury, 65 severe cutaneous adverse reactions, and 148 vision disturbances.

You can read the entire report here.

New Safety Warnings for Chantix

FDA ALERT [7/1/2009]:  
FDA has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.  These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.  The same changes to the prescribing information and Medication Guide for patients will also be required for bupropion products (Wellbutrin and generics)that are indicated for the treatment of depression and seasonal affective disorder.

FDA NEWS RELEASE

For Immediate Release: July 1, 2009

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)

Audience: Neuropsychiatric healthcare professionals, patients

FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.

[07/01/2009 - Public Health Advisory - FDA]

Previous MedWatch Alert:

[02/01/2008]

FDA issued a Public Health Advisory on Feb. 1, 2008, to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline). Chantix is a prescription medication used to help people stop smoking.

Chantix was approved by FDA in May 2006. In November 2007, FDA issued an Early Communication to tell the public and health care providers that the agency was evaluating adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal thoughts, and attempted and completed suicide.

As FDA continues its review of the adverse event reports, it appears increasingly likely that there may be an association between Chantix and serious mood and behavior symptoms.

FDA NEWS RELEASE

FDA Issues Public Health Advisory on Chantix
Agency requests that manufacturer add new safety warnings for smoking cessation drug

The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. 

FDA will continue to update health care professionals with new information from FDA's continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency's continuing reviews and conclusions warrant.

You can find complete article and more information here