Health Canada, which is the regulatory health department in Canada, released a public communication and sent a letter to healthcare professionals on June 3, alerting them to the fact that it had strengthened health risk warnings on Champix, which is sold as Chantix in the United States.

The additional information includes a boxed warning regarding the risk of neuropsychiatric side effects, such as changes in mood and behavior, and also includes a warning of serious allergic and skin reactions, which can include Stevens-Johnson Syndrome.

“There have been continuing Canadian and International post-marketing reports of serious neuropsychiatric symptoms, such as depressed mood, agitation, aggression, hostility, changes in behavior, suicide related events and worsening of pre-existing psychiatric disorder in patients treated with Champix,” Health Canada warned. “These events have occurred in patients with and without pre-existing psychiatric disorder.”

This is not the first time Health Canada has warned users about the risk of suicide with Champix. In January 2009, the health officials issued a reminder to Canadians who were taking the drug or considering the smoking-cessation aid, urging users and their family members or loved ones to be aware of any unusual thoughts or behavior and to immediately stop using the drug if they experienced problems.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the Chantix side effects have been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric problems, which have resulted in fatal or catastrophic injuries for many users.

Stevens-Johnson Syndrome (SJS) is a severe skin reaction that can occur as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.

In the United States, the FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 about the potential psychological side effects. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms and suicide with Chantix occur and what conditions cause them.

There have been several high-profile suicides on Chantix that have garnered media attention, including a Dallas musician and a Georgia politician.

Lawsuits over Chantix have been filed in state and federal courts throughout the United States on behalf of individuals who have suffered injuries from the neuropsychiatric side effects of Chantix, skin reactions from Chantix and for family members of individuals who have committed suicide on Chantix.

In October 2009, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Chantix lawsuits in the U.S. District Court for the Northern District of Alabama. According to a pretrial scheduling order issued earlier this year, the first Chantix trial is unlikely to reach a jury until at least 2012.

Health Canada issued the Avelox liver injury warning to health care professionals on Monday, following a safety review of Avelox side effects. The reviewers concluded that Avelox can cause rare, but potentially fatal, liver injury and liver failure.

Health Canada is requiring Bayer to update the label warnings of the drug in Canada to include the association with severe liver injury.

Avelox (moxifloxacin) is an antibiotic sold by Bayer, which was approved in the United States by the FDA in 1999. It is currently sold in more than 80 countries. Avelox is a member of a family of drugs known as fluoroquinolones, which includes other antibiotics such as Levaquin, Cipro, Proquin, and Floxin. They are used to prevent infection by stopping the reproduction of bacteria and are a popular class of medications.

All of the drugs of this class have been linked with an increased risk of tendon ruptures, but the risk appears to be greatest with Ortho-McNeil-Janssen Pharmaceuticals, Inc.’s Levaquin (levofloxacin). According to reports received by the FDA, Levaquin tendon ruptures accounted for 61% of all fluoroquinolone-associated ruptures between November 1997 and December 2005. However, the drug only accounted for about 45% of all prescriptions written for fluoroquinolones during that time.

Fluoroquinolones, as a group, were also linked to vision problems by a September 2010 study by researchers from the Casey Eye Institute in Oregon. They found that the drugs could cause double vision, a condition that goes away when patients stop taking the drug.

The Chantix class action lawsuit was filed in British Columbia Supreme Court last month. The plaintiffs, Patricia Clow, Nicole McIvor and Alicia Pickering, say that Pfizer was required to give patients and doctors more warning regarding the severity of the psychological side effects of the stop-smoking drug.

Clow alleges that her 22-year old daughter committed suicide in October after taking Champix/Chantix. McIvor claims that the drug caused her to become so suicidal that she tried to ram her car into an oncoming logging truck. Pickering says she became so depressed and suicidal while taking the drug that she required hospitalization.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the drug has been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric problems, which have resulted in fatal or catastrophic injuries for many users.

The FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 about the potential psychological side effects. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms with Chantix occur and what conditions cause them.

In October 2009, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal lawsuits over Chantix in the United States. Dozens of similar cases are centralized in the U.S. District Court for the Northern District of Alabama, and Chantix lawyers are continuing to investigate hundreds of other potential cases that are expected to be filed in the coming months.

The Canadian Chantix class action suit claims that Pfizer put profits ahead of public safety. Under Canadian law, if the plaintiffs prove Pfizer was negligent, participants in the class action could be awarded Pfizer’s Canadian profits from the drug, which has been prescribed to 1.5 million Canadians since 2007.

The U.S. Consumer Product Safety Commission (CPSC) and Health Canada announced a recall of the Coil Nailer on March 11, saying that the nail guns have a defective feeder mechanism that sometimes fires out the nails sideways. The CPSC and Health Canada warned that the nail guns pose a serious injury hazard to the users or bystanders.

In the U.S., Hitachi Koki Co. Ltd. has received 37 reports of nails being fired out of the gun sideways, 15 of those cases resulted in injuries. The CPSC said that the most frequent injuries were to the eyes, in some cases resulting in partial blindness. Canadian officials also reported three injuries, one of which also resulted in partial blindness.

The nail guns are used to fire nails into wood, drywall and other materials. Coil nail guns hold long, flexible nail strips that allow them to carry more of a nail payload than traditional stick nail guns. They fire the nails into surfaces pneumatically.

About 65,000 Hitachi Coil Nailers have been affected by the recall; 50,000 in the U.S. and 15,000 in Canada. All of the recalled nail guns have a model number of NV83A2, which can be found on the body. The recall affects coil nailers manufactured between October 2002 and September 2005. The manufacturing date can be found at the end of the serial number on the end of the handle. The first digit represented the month and the second digit represents the year. Months January through September correspond with numbers 1-9, while October, November and December are represented by the first letter in the name of the month. The year is represented by the last digit of the year (2 for 2002, 3 for 2003, etc.).

The coil nailers were sold at Lowe’s, Home Depot and other home improvement stores nationwide, as well as online through Amazon.com from November 2002 through March 2006 for between $350 and $400.

The CPSC and Health Canada recommend that consumers immediately stop using the recalled coil nailers and contact Hitachi Koki U.S.A., Ltd. for a free repair at www.hitachipowertools.com.

Biphenol A, which is commonly referred to as BPA, is used in a variety of plastic consumer products, like sports bottles, infant feeding bottles, soda cans and food containers. The chemical is used to make the plastic hard and shatterproof, but there are substitutes available that do not carry the same potential long-term risks.

Concerns over toxic baby bottles have grown over the past year, as studies have suggested that low doses of BPA can be absorbed by the body over a long period of time, potentially resulting in developmental and health problems in fetuses, infants and children.

Although there has been a ban on BPA baby bottles in Canada due to the potential risk they pose to children, the FDA has taken the controversial position that the amounts of the chemical used in consumer products are too small to be toxic.

In October 2008, an independent panel of advisors to the FDA concluded that the agency’s position was flawed, indicating that it does not consider all available and credible scientific evidence. As a result, in December 2008, the FDA agreed to re-evaluate its research on Bisphenol A and determine whether additional studies are need to look into the safety of the chemical. However, they have given no indication that they intend to ban use of the chemical.

The attorney generals of several states sent letters to eleven manufacturers of baby products in October 2008, calling on them to voluntarily agree not to sell the toxic infant bottles despite the FDA’s current position.

As of March 6, 2009, Evenflo, Avent, Gerber, Disney First Years, Platex and Dr. Brown have agreed to stop selling toxic infant bottles with BPA. Large retailers like Babies R’ Us and Wal-Mart have also indicated that they will not carry any BPA baby bottles.

A toxic baby bottle class action lawsuit was filed in June 2008 against these same manufacturers, alleging that they have failed to issue adequate warnings or information about the risks associated with BPA.

The drug regulatory agency in Canada issued a statement on March 5, 2009, warning that Canadians should not use these oral sodium phosphate products for bowel prep unless they are specifically recommended by their doctor in an individual case.

Although the products appear to be safe when used at lower doses as a laxative, when used to cleanse the bowels as part of colonoscopy prep or before other medical procedures, oral sodium phosphate side effects could a serious kidney injury known as acute phosphate nephropathy. This could result in renal failure, the need for dialysis treatment, a kidney transplant or death.

In Canada, there are three authorized oral sodium phosphate products that are labeled for laxative use and as a bowel cleanser, Phoslax, Fleet Phospho-soda Oral Laxative and Phosphate Solution, which is sold as Pharmasave Phosphates Solution, Option + Phosphates Solution and Reserve Phosphates Solution.

Health Canada reports that they have received reports of at least 53 oral sodium phosphate adverse reactions, with 30 of them involving kidney problems and 27 of those reported as serious. Allergic reactions, gastrointestinal symptoms, neurological and cardiovascular problems were also reported as other adverse effects.

In the United States, the FDA issued a warning about the risk of kidney injury from oral sodium phosphate products in December 2008, and required that two prescription products add a “black box” warning about the risk of acute phosphate nephropathy, which is the strongest warning that can be placed on a prescription product.

In a statement released by the FDA on December 11, 2008, the U.S. drug regulators also indicated that over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, should not be used as a bowel prep due to the potential side effects.

The same day the FDA warned about the risk of kidney problems, a Fleet Phospho-soda recall was issued and the manufacturer, C.B. Fleet, indicated that they will stop selling the product as an over-the-counter laxative, but may seek approval to market the product as a prescription drug.

Since 2004, nearly 200 Fleet Phospho-soda lawsuits have been filed in the United States in various state and federal courts alleging that the manufacturer failed to warn that using high doses of the over-the-counter laxative as a bowel prep for colonoscopies could lead to potentially life-threatening kidney injury.

Botox and Botox Cosmetic contain tiny amounts of the nerve toxin, Botulinum Toxin A, which is the bacteria associated with the development of Botulism. In Canada, it is approved for treatment of muscle spasms in the neck, eye and foot, muscle pain, excessive sweating and for cosmetic purposes to reduce wrinkles.

According to a release issued January 13, 2009, Health Canada informed health care professionals on that the labels will be updated to include the risk of “distant toxin spread,” which can be fatal and produces possible symptoms like pneumonia, muscle weakness, breathing problems, swallowing difficulties and speech disorders.

Health Canada notified doctors in October 2008 that they were investigating at least thirteen reports of Botox side effects, including at least five deaths. All five of the Botox deaths involved the use of the drug to treat neck and muscle spasms, with two involving children with cerebral palsy given Botox. Only one of the 13 reports involved Botox cosmetic use.

Canadians who receive Botox or Botox Cosmetic products have been advised to seek immediate medical care if swallowing, speech or breathing disorders arise.

“Canadians with a history of underlying neurological disorders, swallowing difficulties and/or breathing problems should use these products with extreme caution,” warned Health Canada in a statement posted on their website. “Botox and Botox Cosmetic products should only be used under specialist supervision in those patients and should only be used if the benefit of treatment is considered to outweigh the risk.”

In the United States, the FDA issued a public health warning in February 2008 about reports of Botox breathing problems, deaths and other adverse reactions, especially when used off-label for treatment of spasticity for children with cerebral palsy.

At least one Botox lawsuit was filed in July 2008, in the Superior Court of California, on behalf of 15 people who alleged that they suffered serious or fatal injuries due to Botox problems. The lawsuit alleged that the drug manufacturer, Allergan, Inc., failed to warn about the side effects and promoted Botox for users not approved by the FDA or determined to be safe and effective.

The children’s cough and cold drugs include over 800 popular products marketed without a prescription, such as Pediatric Tylenol, Triaminic, Dimetapp, Vicks, Little Noses and Pediacare.

Side effects of the children’s cough and cold drugs have been associated with reports of hallucinations, suppressing respiratory systems, increasing heart rates, and a potential increased risk of strokes and seizures.

Health Canada, which is the drug regulatory agency in Canada, indicates that they are requiring the manufacturers of these cough and cold medicines for children under 12, to retable their products in Canada to indicate that they should not be used in children under 6.

“Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children,” said the government health agency in a statement released December 18, 2008. “In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under 6.”

Earlier this year, the makers of the over-the-counter children’s cough and cold drugs resisted calls in the United States by consumers advocacy groups and experts urging a ban on the use of the drugs by children up to 6 years old.

On October 7, 2008, the Consumer Healthcare Products Association, which is an industry trade group representing the pharmaceutical industry, announced that they were voluntarily changing the labels of the children’s drugs to indicate that they should not be used in children under 4. The FDA then released a statement that they support the decision by the drug industry.

Public Citizen, which is a prominent consumer group that has been calling for a 6 year age limit in the United States, indicated that the decision to only limit use in children under 4 in the United States was not based on scientific evidence, but instead a political compromise between the age limit of 6 urged in a petition filed last year, and the limit of 2 which the drug industry had on the medications at that time.

The market for over the counter children’s cough and cold drugs is a big industry, with over 800 products available to treat coughs, sore throats, runny noses and fevers. Nearly 100 million packages of oral cough and cold drugs for children are sold every year, generating over $311 million in sales.

Trasylol, which is also known as an aprotinin injection, is used to control bleeding during cardiac surgery. However, a number of studies have uncovered that there are several serious Trasylol side effects, including an increased risk of kidney failure, heart attacks, strokes and death.

A new study was released yesterday, which is scheduled to be printed in the January 20, 2009 edition of the Canadian Medical Association Journal, which concludes that the risk of death from Trasylol is higher than other anti-bleeding medications, known as lysine analogues.

The study, which involved the evaluation of data from 49 different randomized clinical trials, was released the day before a panel of advisors to Health Canada, the drug regulatory agency in Canada, were scheduled to meet to review future use of the drug.

A prior study published earlier this year in the New England Journal of Medicine, known as the BART study (Blood Conservation using Antifibrinolytics in Randomized Trial), found that heart bypass patients given Trasylol were 53% more likely to die than those treated with tranexamic acid (Cyklokapron) and aminocaproic acid (Amicar), which are other anti-bleeding drugs.

Bayer suspended marketing of Trasylol in November 2007 after researchers stopped the BART trial in October 2007, before the original date the study was to conclude. The BART trial was stopped after preliminary results demonstrated the substantial risk of death.

In the United States, a full Trasylol recall was issued in May 2008, and any remaining stock of the drug as removed from the market. However, Bayer continues to sell aprotinin in some countries.

The Trasylol class action lawsuit filed in Canada alleges that Bayer failed to adequately warn patients and physicians of the increased risk of serious injury associated with the use of Trasylol when compared to safer alternatives.

The Zyprexa class action lawsuit seeks over $700 million against the drug maker for failing to warn about side effects of Zyprexa like severe weight gain, diabetes, hyperglycemia and pancreatitis.

Zyprexa (olanzapine) is an atypical antipsychotic medication, which has generated sales of about $4.8 billion a year worldwide.

In the United States, as a result of similar claims filed by users who suffered diabetes and other injuries allegedly caused by Zyprexa, Lilly has already paid over $1.2 billion to settle about 30,000 lawsuits. They have also paid millions to settle state claims, and could face fines in excess of $1 billion following a Justice Department investigation into their marketing of the drug for unapproved uses.

Bloomberg News reports that in the Canadian Zyprexa class action lawsuit, Eli Lilly could face liability for enormous amounts of money with the plaintiffs able to go after the company’s sales.

According to Judge Sidney Lederman, who originally allowed the claims in 2007, “[t]he ramifications of exposure to this type of liability will extend beyond the parties to affect not just the pharmaceutical industry as a whole, but also the securities market.”

Lilly may still appeal the decision to the Supreme Court of Canada