This press statement on gel fuels and other illuminating fuels was released by the U.S. Consumer Product Safety Commission on June 14, 2011.

CPSC staff initiated an investigation last week into serious burn incidents apparently related to gel fuel used in firepots. While CPSC’s investigation is still open and active, consumers should be aware of the burn and poisoning hazards that can occur from using illuminating fuels in firepots, tiki torches, and other consumer products. CPSC staff recommends that consumers never refuel a hot product as this can create a serious situation of the fuel splattering and burning those nearby. Adding fuel to an open-flame is a potentially hazardous activity, with a risk of burns and uncontrolled fires. It is important to follow proper safety guidelines when refueling any open-flame device. CPSC staff recommends that consumers first look for flames, then cautiously feel the vicinity of the flame, as some flames are difficult to see. Only add fuel when the flames are extinguished and the container is cool to the touch. Never pour fuel over an open flame.

Consumers should keep the fuel out of the reach of young children and when not in use, store it away from children. Always securely replace the child resistant cap after use. Most illuminating fuels are sold in special child-resistant packaging because they generally consist of petroleum distillates, a specific class of hydrocarbon chemicals. This class of chemicals is particularly hazardous if ingested and aspirated into the lungs, where it can cause chemical pneumonia, pulmonary edema, or death. Illuminating fuels should never be transferred to other containers, as young children may mistake the new container with containers of common drink items.

Learn more about the gel fuel burns.

Have you been injured? Do you have a question about a potential case? We may be able to help you get answers.

Chantix Timeline

May 2006

Chantix is approved by the FDA as a treatment for those trying to quit smoking. In the FDA’s press release on the approval of Chantix, it cited "the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence (gas), insomnia, abnormal dreams, and dysgeusia (change in taste perception)."

November 2007

The FDA released concerns about the drug after receiving "reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix." At the time, the FDA cautioned patients and their doctors to closely observe changes in behaviors or mood, to use caution when operating heavy machinery, and to stop taking the drug if behavior side-effects occurred.

January 2008

Pfizer stopped advertising Chantix.

February 2008

The FDA followed up their initial concerns with a public health advisory altering patients and providers to new safety warnings about Chantix. Although not a black box warning, the most serious kind, the warning did require a labeling change from Pfizer.

May 2008

Following the release of a new study by the Institute for Safe Medication Practices and a Public Health Advisory issued by the FDA, the FAA ordered pilots and air traffic controllers to stop taking the drug immediately. The study "found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix."

September 2008

Pfizer began running new ads for Chantix. The new ads, however, don’t refer to the drug by name, instead the ads direct consumers to a web site. This "unbranded advertising" technique allows drug makers to draw in consumers without having to list the side effects of the drug they’re trying to market.

Injured by Chantix? Pittsburgh Chantix Layer

If you or a loved one has been injured taking the smoking cessation drug Chantix, and would like to speak with a Chantix lawyer, please contact us today for a free, no obligation consultation.

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.

As the agency’s review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals and patients informed of new and emerging safety data.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug."

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.

Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

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.

For more information: http://www.fda.gov/cder/drug/infopage/varenicline/default.htm

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients. GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

For more information:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

FDA Issues Safety Alert on Avandia
www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

Issues with the leads was first noted in March and physicians were notified. Data accumulated since has prompted Medtronic to stop producing, selling, and distributing the Spring Fidelis leads. Products currently on shelves should be returned to Medtronic.

The defibrillator leads recall does not, however, necessitate the surgical removal of already implanted devices at this time; an adjustment of the defibrillator’s settings is recommended. While the rate of adverse effects is currently less than 1%, it is unknown if this rate will increase as more time passes and leads have been in place for longer.

Adverse effects may include major complications or even death. Medtronic has identified five cases in which the faulty leads may be responsible or a contributing factor in the death of the patient.

Patients currently implanted with affected devices–approximately 268,000 worldwide–should speak with their physicians. A small number of non-Medtronic defibrillators are also fitted with the Sprint Fidelis leads. Patients with another manufacturer’s device that utilize the faulty leads, or those unsure of their leads’ manufacturer, should contact their doctor.

Medtronic’s decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.

These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.

Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.

Background:

Today, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.

Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today’s action.

Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.

When a defibrillator lead is slightly more prone to fracture, it doesn’t mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don’t know if this rate of adverse events will remain constant or increase over the life of these leads.

FDA considers Medtronic’s action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word "recall" to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.

The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic’s recommendation that defibrillator settings be adjusted at the patient’s next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.

Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.

Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.

FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.

The Sprint Fidelis leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). Approximately 268,000 Sprint Fidelis leads have been implanted worldwide. This action does not affect Medtronic pacemaker patients.

The U.S. Food and Drug Administration (FDA) intends to issue a public statement regarding Medtronic’s decision at www.fda.gov.

Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis.

This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Based on Medtronic’s extensive performance data, Sprint Fidelis lead viability is trending lower than Medtronic’s Sprint Quattro® lead at 30 months (97.7% Sprint Fidelis vs. 99.1% Sprint Quattro). This difference is not statistically significant; however, if the current lead fracture rates remain constant, it will become so over time. Medtronic believes that given this performance trend and its ability to identify the primary fracture locations, this action is in patients’ best interest.

Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output. Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.

“There is nothing more important to us than the safety and well-being of patients,” said Bill Hawkins, president and chief executive officer of Medtronic. “We take all matters of product quality very seriously and believe this action is the right thing to do given currently available information.”

Medtronic Outreach to Physicians and Patients

In conjunction with Medtronic’s Independent Physician Quality Panel, Medtronic today communicated, via letter and direct outreach with more than 13,000 physicians worldwide, the Sprint Fidelis lead performance data and updated patient management recommendations for patients who are implanted with Sprint Fidelis leads. These recommendations include device programming and patient management recommendations that will ensure a patient’s device is set to more effectively monitor for potential problems and provide an audible alert in the event of lead fractures.

“Medtronic has acted responsibly to address concerns about the possibility of lead fractures and to minimize harm to patients,” said Kevin Hackett, M.D. of Columbus Cardiology Consultants and member of Medtronic’s Independent Physician Quality Panel. “The Physician Panel has reviewed Medtronic’s data and believes they are taking the correct action.”

Information for Patients

Medtronic recommends that patients, who believe they may have a Fidelis lead, consult with their physicians. It is important to note that Medtronic pacemaker patients are not affected by this action. Medtronic will communicate directly to affected patients and encourage them to contact their physicians for more information. Medtronic has established the following website – www.medtronic.com/fidelis – and a toll-free number (1-800-551-5544 ext. 41835) for patients seeking information.

In addition to being equally effective (and in some cases, superior), side-effects were considered less severe and costs considerably lower. Glucophage (metformin) is available in generic form at about $100 for a year’s supply; a month’s supply of Avandia or Actos can be more than twice that.

Consumer Reports created a users’ guide to the information presented in the study, naming the metformin generic as a CR Best Buy. Users for whom metformin alone is ineffective or not well tolerated should consider either glimepiride (Amaryl and generic) or glipizide (Glucotrol and generic). Consumer Reports argued that only the small number of people for whom all of the preceeding drugs prove unusable should consider Actos or Avandia.

While the safety of Avandia is set to be debated before the FDA on July 30th, the drug’s maker GlaxoSmithKline defended the safety and effectiveness of their product in a July 16 press release, arguing that "Avandia is superior in long-term control of blood sugar over five years compared to metformin." However according to a July 16, 2007 article by CNN, the results come as no suprise to diabetes experts:

The conclusions mirror those of an expert panel that leading U.S. and European diabetes groups convened last year, said Dr. David Nathan, diabetes chief at Massachusetts General Hospital. He has received speaker fees from several diabetes drug makers.

Metformin is "an incredibly inexpensive generic drug, which is why we found it so appealing," Nathan said.

Also See:

"Older drugs are the best choice for most people with type 2 diabetes." Consumer Reports. July 2007. <http://www.consumerreports.org/… .htm> (July 17, 2007.)

"Most people with type 2 diabetes should avoid new, heavily advertised drugs–notably Avandia and Actos–because older medications are cheaper, just as effective, and as safe if not safer, according to a new study and a report based on it from Consumer Reports Best Buy Drugs."

"Analysis: Older, cheaper diabetes drugs get high marks." CNN.com. July 16, 2007. <http://www.cnn.com/2007/HEALTH/conditions/07/16/diabetes.drugs.ap/index.html> (July 17, 2007.)

"The clear winner: metformin, sold as Glucophage and generically for about $100 a year. It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol."

Press Release: "GlaxoSmithKline Responds to Reviews of Oral Diabetes Medications." GlaxoSmithKline. July 16, 2007 <http://www.gsk.com/media/press-kits/avandia-16july2007.pdf> (July 17, 2007.)

Bolen, et al. "Systematic Review: Comparative Effectiveness and Safety of Oral Medications for Type 2 Diabetes Mellitus." Annals of Internal Medicine. September 18, 2007, Volume 147 Issue 6.<http://www.annals.org/cgi/content/full/0000605-200709180-00178v1> (July 17, 2007.)

“Conclusions: Compared with newer, more expensive agents (thiazolidinediones, α-glucosidase inhibitors, and meglitinides), older agents (second-generation sulfonylureas and metformin) have similar or superior effects on glycemic control, lipids, and other intermediate end points. Large, long-term comparative studies are needed to determine the comparative effects of oral diabetes agents on hard clinical end points.”

Earlier this spring, The New England Journal of Medicine released a study by Dr. Steven Nissen that analyzed the combined results of 42 clinical trials. Their findings indicated that patients on rosiglitazone experienced an increased risk of heart attack by 43% and other cardiovascular-related deaths by 64%.

In the wake of the study results, the FDA requested that Avandia label get a "black box warning," the most serious warning the FDA can request. Additionally, "Safety alert on Avandia" was issued by the FDA which said, in part:

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

The House Oversight and Government Reform Committee subsequently held a hearing to debate the FDA’s role in evaluating the safety of Avandia. At the hearing, diabetes expert Dr. John Buse testified to feeling intimidated by drug maker GlaxoSmithKline when he expressed misgivings about the drug’s safety as early as 1999.

According to a June 5 article in The New York Times, Buse wrote a letter in March of 2000 to the FDA in which he "criticized [GlaxoSmithKline's] marketing, saying it employed ‘blatant selective manipulation of data’ to overstate the drug’s benefits and understate its risks."

The drug’s detractors claim overagressive marketing, both to doctors and direct to consumers, despite GlaxoSmithKline’s awareness of the risks will provide for failure-to-warn lawsuits similar to those resulting from arthritis drug Vioxx. Avandia’s supporters, however, cite several studies that do not show a correlating increase in risk.

Debate will likely increase, both over the safety of Avandia and the effectiveness of the FDA’s procedures surrounding drug approval, specifically, the lacking requirement for subsequent safety and effectiveness evaluations by drug makers after receiving approval to market their drug.

In an interview with USA Today, former deputy director of the Division of Drug Risk Evaluation, Rosemary Johann-Liang, the burden of proof required to call a drug’s safey into question is greater than that required to show its effectiveness:

The FDA approves diabetes drugs such as Avandia if clinical trials show they meet the "surrogate endpoint," or goal, of lowering blood sugar, [Johann-Liang] says, but then doesn’t require makers to do follow-up studies of whether patients actually feel better and live longer.

On the other hand, Johann-Liang says, "if there is a safety issue with the drug, it must be confirmed. I just don’t think that that’s appropriate." As a result, "we’re not doing things in a timely way."

Sources & Further Reading

• Rubin, Rita. "FDA scientist says she was reprimanded for warning." USA Today. June 10, 2007. <http://www.usatoday.com/news/health/2007-06-10-fda-insider_n.htm>. June 29, 2007.
• "FDA Issues Safety Alert on Avandia." FDA.gov. May 21, 2007. <http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html>. June 29, 2007.
• Saul, Stephanie. “Doctor Says Drug Maker Tried to Quash His Criticism of Avandia.” The New York Times. June 2, 2007. <http://www.nytimes.com/2007/06/02/business/02drug.html?…ei=5070>. June 29, 2007.
• Nissen, Steven E., M.D., and Kathy Wolski, M.P.H. “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The New England Journal of Medicine. Volume 356:2457-2471; June 14, 2007; Number 24. <http://content.nejm.org/cgi/content/short/356/24/2457>. June 29, 2007.
• Hearing on FDA’s Role in Evaluating Safety of Avandia. Committee on Oversight and Government Reform. June 6, 2007. <http://oversight.house.gov/story.asp?ID=1325>. June 29, 2007.