Summer, Sunglasses, UVB and UVA, Protect your eyes.

Tips for choosing sunglasses

For most people, a low-cost pair of sunglasses with UVB and UVA protection will do the job.
Follow these safety tips when choosing sunglasses to reduce your risk:

• Choose close-fitting wrap around eyewear. Close-fitting or wrap-around sunglasses helps to prevent stray light from entering from the sides.
• Choose dark lenses. Make sure the lenses are dark enough to keep your eyes comfortable, but not so dark that they reduce your vision.
• Reduce glare. If you spend a lot of time outdoors with intense glare from sunlight bouncing off snow or water, you should wear sunglasses that block blue light. Medium to dark lenses with a grey, or slightly brown or green tint, will filter out most blue light.
• Choose scratch-resistant coatings. Most sunglasses have plastic lenses. These lenses are tougher than glass and less likely to shatter. If you buy plastic lenses, look for a pair with a scratch-resistant coating.
• Check for distortion. Check the lenses for distortion by putting the sunglasses on and looking at a rectangular pattern, such as floor tiles. If the lines stay straight when you move your head up and down, and side-to-side, then the amount of distortion is acceptable.
• Get enough UV protection. You cannot tell how much UV protection a pair of sunglasses will provide by their price, colour, or by the darkness of the lenses. Look for a label with UVB and UVA protection.

Amount of UV protection

Manufacturers follow voluntary industry standards when labelling sunglasses. Sunglasses that comply with industry standards for UV protection are grouped in three categories:

• Cosmetic sunglasses have lightly tinted lenses for use in sunlight that is not harsh. They block up to 60 percent of visible light and UVA rays, and between 87.5 and 95 percent of UVB rays. These glasses are not usually recommended for daylight driving.
• General purpose sunglasses block from 60 to 92 percent of visible light and UVA rays, and between 95 and 99 percent of UVB rays. These sunglasses are good for driving, and are recommended whenever sunlight is harsh enough to make you squint.
• Special purpose sunglasses block up to 97 percent of visible light and up to 98.5 percent of UVA rays. They also block at least 99 percent of UVB rays, and are suitable for prolonged sun exposure. These sunglasses are not recommended for driving.
• Contact lenses, even those with UV protection, does not provide full coverage for the eyes and the skin around the eyes.

Types of lenses

Sunglasses are made with different kinds of lenses to meet different needs:

• Regular lenses reduce the brightness of everything evenly.
• Polarizing lenses are designed to cut glare due to reflection. This means they are good for driving and outdoor activities in the snow or on water.
• Photochromic lenses change with the intensity of UV light by turning darker when outdoors and lighter when indoors. If you wear these for driving, choose sunglasses that are fairly dark.
• "Flash" or mirror lenses reflect all or part of the light instead of absorbing it. They offer no performance advantage because they scratch easily. You should choose a pair with a scratch-resistant coating.

About ultraviolet radiation and visible light

The sun produces many different kinds of energy. The kinds most likely to injure the eye are:

• ultraviolet radiation, which is invisible and is often called "UV rays"
• bright or intense light
• blue light

UV rays carry more energy than visible light rays, so the eye is at greater risk of damage from absorbing UV rays than from absorbing other kinds of light. There are two types of UV rays that reach the Earth's surface: UVA and UVB. These rays can cause, or speed up the progress of, several diseases that affect the eye or its supporting structures. UVB rays have also been linked to skin cancer.
Most of the damage caused to eyes by UVB and UVA rays happens over a long period of time and cannot be reversed. Sensitivity to UV rays varies from one person to the next.
Blue light is visible light in the blue portion of the colour spectrum. The intense glare of light reflecting off snow or water contains blue light. Your eyes cannot focus clearly in blue light. Some scientists believe that routine exposure to blue light over many years may age the retina and increase the risk of blindness in some people over the age of sixty.

How the sun can damage your eyes

When your eyes absorb ultraviolet radiation and visible light from the sun, heat or chemicals react in eye tissue. These reactions can cause permanent damage if the eye's natural ability to heal itself is overwhelmed.
Different parts of the eye absorb different kinds of UV rays and visible light. For example:

• The surface layers of the outer part of the eyeball (the cornea and the conjunctiva) absorb UVB rays.
• The lens absorbs mainly UVA rays.
• The retina (the light-sensitive lining at the back of the inner eyeball) absorbs visible light.

If eyes are overexposed to UV radiation, the front portion of the eyes can be damaged. If visible light is too bright or intense, or if you stare directly at the sun, even briefly, the retina can be damaged, causing permanent loss of vision. UV radiation, along with wind and drying of the eye, may cause snow blindness, an uncomfortable but temporary condition.
There is some evidence that daily exposure to UV radiation in very bright sunlight over many years may increase the risk of developing cataracts. Cataracts cause a gradual clouding of the natural lens of the eye.
Thank you Health Canada!

Canada suspends Allergan's licences for its Biocell breast implants

Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer

 

OTTAWA – Health Canada has completed an update to a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and has found that the rate of BIA-ALCL in Canada is significantly higher in patients with macro-textured breast implants compared to other implants. As a result, because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licences for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).

This means that no one can sell Allergan’s Biocell breast implants in Canada or import them into the country (Set out in the chart below). At Health Canada’s request, Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market. Allergan’s other breast implant products are not affected by this decision.

Affected products

Licence number	Licence name
3112	NATRELLE SALINE-FILLED BREAST IMPLANTS (TEXTURED)
72262	NATRELLE 410 TRUFORM SILICONE - FILLED BREAST IMPLANTS
72263	NATRELLE SILICONE - FILLED BREAST IMPLANTS - BIOCELL ROUND
87277	NATRELLE INSPIRA TRUFORM 1 (RESPONSIVE) BREAST IMPLANT (TEXTURED SHELL)
87279	NATRELLE INSPIRA TRUFORM 2 (SOFT TOUCH) BREAST IMPLANT (TEXTURED SHELL)

The license suspensions follow Health Canada’s announcement on April 4, 2019, that it intended to suspend Allergan’s Biocell licences unless the company could provide evidence within two weeks to support that the benefits of the use of the devices outweighed the risks.

Health Canada received a response from Allergan on April 17, 2019, which departmental experts reviewed. It was determined that the information provided by the manufacturer was insufficient to support the ongoing licensing of the devices. The department concluded that the potential risks associated with the devices outweigh the potential benefits.

BIA-ALCL is a serious but rare type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after a breast implant procedure. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. While the cause is unknown, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.

Health Canada has been notified of 26 confirmed Canadian cases of BIA-ALCL, of which 22 (85%) involve Allergan's Biocell breast implants. Based on Canadian confirmed case data and devices sales data provided by the manufacturers, Health Canada estimates that the risks of BIA-ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants. No cases of BIA-ALCL have been reported in Canada with any smooth surface implants.

Health Canada takes patient health and safety very seriously. As a result of the safety review findings, the Department will also:

• work with all breast implant manufacturers to strengthen the “Instructions for Use” of all breast implants on the risk of BIA-ALCL;
• work with stakeholders to develop new information tools to support informed decision-making for individuals considering breast implants;
• continue to monitor for newly reported Canadian cases of BIA-ALCL, including a yearly follow-up with manufacturers of breast implants; and
• take appropriate and timely action if any new health risks are identified related to breast implants.

If you have an Allergan Biocell breast implant or another type of breast implant:

• Removing your breast implants is not recommended if you do not have any signs or symptoms suggesting BIA-ALCL. Patients should discuss the risks and benefits of removal with their healthcare professional.
• If you don’t know what type of breast implant you have, you should speak with the healthcare provider who did your surgery.
• Conduct regular breast self-exams and see your healthcare professional for periodic follow-ups.
• If you experience unusual changes to your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional.
• You can find helpful information on the risks associated with breast implants, including the risk of BIA-ALCL, by visiting the breast implant sectionon Canada.ca.

If you are considering getting breast implants:

• You should get information about the risks and benefits of getting breast implants, and discuss them with a healthcare professional.
• If you do decide to get breast implants, have a conversation with your healthcare professional about which type of implant is the best choice for you.
• You can find helpful information about breast implants, including what you should ask the surgeon, by visiting the breast implant section on Canada.ca.

Information for healthcare professionals

• Provide patients with the appropriate information about the risks, including the risk of BIA ALCL, and benefits associated with their options, so that they can make an informed decision before a breast implant procedure.
• Stay informed about the signs and symptoms of BIA-ALCL and the testing tools used to recognize and diagnose BIA-ALCL.
• Report incidents of BIA-ALCL to Health Canada. Include specific details, such as type of implant, symptoms, how BIA-ALCL was discovered, age of patient at implantation, prior implant history, age of patient at discovery, tests conducted to diagnose, staging information, course of therapy and clinical outcomes.

Report health or safety concerns

• Report complaints involving medical devices to Health Canada.
• Stay connected with Health Canada and receive the latest advisories and product recalls.

The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that regulations and guidance keep pace. As part of Health Canada’s Action Plan on Medical Devices, announced in December 2018, the Department is taking steps to strengthen the monitoring and promotion of medical device incident reporting. In addition, to better support women’s health, Health Canada has established a new Scientific Advisory Committee on Health Products for Women.

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709

Barbecue Safety, inspect your metal bristle barbecue brush regularly.

Summer is coming and everyone is pulling out their Barbecues and associated utensils and getting ready for the BBQs for friends and family.
But that metal bristle brush, what was the last time you really had a look at it?  I am asking because
when we continuously use it, the metal bristle brushes that many people use to clean their barbecue grills can lose their bristles. If some how caught in food and accidentally ingested, these metal bristles can cause serious health problems.Barbecue Safety, inspect your metal bristle barbecue brush regularly
Health Canada is suggesting that;
 

To minimize the risk of issues with your metal bristle barbecue brush, you should:

• regularly inspect your brush for signs of damage;
• inspect grills and barbecued food for loose metal bristles;
• regularly replace your brush to help avoid problems associated with wear; and
• stop using your brush if bristles come loose or stick to the grill.

Here is the Health Canada Press Release;

Consumer Product Update: Have you inspected your metal bristle barbecue brush lately?

Starting date:

May 24, 2019

Posting date:

May 24, 2019

Type of communication:

Information Update

Subcategory:

Household Items, Outdoor Living

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-70033

Last updated: 2019-05-24

Issue

Millions of Canadians enjoy using their barbecues, especially during the warm summer months. Through repeated use, the metal bristle brushes that many people use to clean their barbecue grills can lose their bristles. If accidentally ingested, these metal bristles can cause serious health problems.

What you should do

To minimize the risk of issues with your metal bristle barbecue brush, you should:

• regularly inspect your brush for signs of damage;
• inspect grills and barbecued food for loose metal bristles;
• regularly replace your brush to help avoid problems associated with wear; and
• stop using your brush if bristles come loose or stick to the grill.

What Health Canada is doing

Health Canada and the Retail Council of Canada have commissioned the Standards Council of Canada to develop a voluntary safety standard for barbecue brushes, including metal bristle brushes. The voluntary safety standard will establish ways to reduce the risk that loose bristles will cause injuries to Canadians by defining safety criteria, such as labelling and testing, for these products. A public review of the draft voluntary safety standard is expected to start this summer. The draft National Standard of Canada for barbecue brushes will be published on the CSA Group's website for 60 days for public review and comment.

Health Canada continues to monitor this issue and will take action as required.

Report health or safety concerns

Health Canada advises consumers to check the Government of Canada's Recalls and Safety Alerts website regularly for any recalled products and to report any consumer product-related health or safety concerns.

(613) 957-2991
1-866 225-0709

Media Inquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public Inquiries

(613) 957-2991
1-866 225-0709

Risk of Hepatotoxicity (drug-induced liver injury) From Hoffmann-La Roche's ACTEMRA® (tocilizumab) - Health Canada advisory

Important Safety Information on ACTEMRA® (tocilizumab) - Risk of Hepatotoxicity

Report a Concern

Starting date:

May 21, 2019

Posting date:

May 21, 2019

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs, Biologic/vaccine

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

Healthcare Professionals, Hospitals

Identification number:

RA-69991

Last updated: 2019-05-21

• Issue
• Who is affected
• Report health or safety concerns

Audience

Healthcare professionals including adult and pediatric rheumatologists, hepatologists, gastroenterologists, as well as internists, pediatricians, prescribing physicians, pharmacists, emergency room staff, and nurses in rheumatology clinics, hospital wards and patient care centres where ACTEMRA is administered.

Key Messages

• Serious drug-induced liver injury (DILI), in some cases resulting in acute liver failure requiring a transplant, has been reported in patients treated with ACTEMRA. 
• Healthcare professionals are advised to:
  • not recommend ACTEMRA in patients with active hepatic disease or hepatic impairment;
  • not initiate treatment with ACTEMRA in patients with elevated blood liver enzyme levels above 3 times the upper limit of normal (ULN);
  • discontinue treatment with ACTEMRA in patients with elevated blood liver enzyme levels above 5 times the ULN;
  • exercise caution when considering starting ACTEMRA treatment in patients with liver enzyme levels above 1.5 times the ULN; 
  • monitor liver function tests (LFTs) in patients with rheumatoid arthritis and giant cell arteritis every 4 to 8 weeks for the first 6 months of treatment, followed by every 12 weeks thereafter;
  • monitor LFTs in patients with polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis before treatment begins, at the time of the second ACTEMRA treatment, and every 2 to 4 weeks thereafter;
  • refer to the approved Canadian Product Monograph for guidance on the recommended dose adjustments (reduction, interruption or discontinuation) in patients with liver enzyme elevations; and 
  • advise patients to contact a healthcare professional if they experience signs of liver injury such as loss of appetite, nausea and vomiting, fatigue, itching, dark urine, yellowing of skin and eyes, abdominal swelling and/or pain in the upper-right abdomen.
• Health Canada is working with the manufacturer to include this new safety information in the Canadian Product Monograph.

  

Issue

Serious cases of drug-induced liver injuries (DILI) have been reported in patients treated with ACTEMRA, including cases of acute liver failure requiring a transplant. There have been cases of serious liver injury reported from Canada.

Products affected

ACTEMRA (tocilizumab): 20 mg/mL concentrate solution for intravenous infusion (IV) in 4 mL, 10 mL, and 20 mL vials, and 162 mg/0.9 mL solution for subcutaneous (SC) injection.

Background information

ACTEMRA has market authorization in Canada for use in the following indications:

1. Rheumatoid Arthritis [IV or SC formulations]
ACTEMRA is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis.

ACTEMRA (IV only) in combination with methotrexate (MTX) has been shown to reduce the rate of progression of radiographic joint damage at week 52.

ACTEMRA is to be given in combination with MTX or other disease-modifying antirheumatic drugs (DMARDs). However, in cases of intolerance to MTX or where treatment with MTX is not appropriate, ACTEMRA may also be given as monotherapy.

2. Giant Cell Arteritis [SC formulation only]
ACTEMRA is indicated for the treatment of giant cell arteritis in adult patients.

3. Polyarticular Juvenile Idiopathic Arthritis [IV or SC formulations]
ACTEMRA is indicated for the treatment of signs and symptoms of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have responded inadequately to previous therapy with DMARDs.

4. Systemic Juvenile Idiopathic Arthritis [IV formulation only]
ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with one or more non-steroidal anti-inflammatory drugs and systemic corticosteroids.

ACTEMRA is known to cause transient or intermittent mild to moderate elevation of hepatic transaminases.  This risk is increased when ACTEMRA is used in combination with potentially hepatotoxic drugs (e.g., methotrexate). 

Following Health Canada’s request, the Market Authorization Holder performed a cumulative, comprehensive assessment of serious hepatic injury including hepatic failure reported with ACTEMRA across all available clinical and post-marketing data sources, including data from the Food and Drug Administration Adverse Event Reporting System (FAERS) and Eudravigilance (EV) databases and from the literature. Eight cases of ACTEMRA-related moderate to severe DILI were identified. These events occurred between 2 weeks to more than 5 years after initiation of tocilizumab with median latency of 98 days. Two of these 8 cases required liver transplantation. The total world-wide ACTEMRA exposure is estimated to be 1,066,849 patients (corresponding to 882,370.3 Patient Years) up to April 10, 2018.

Who is affected

Information for consumers

ACTEMRA is a prescription medicine used to treat:

• adults with moderate to severe rheumatoid arthritis;
• adults with giant cell arteritis, an inflammation in the arteries, especially the ones in the temples; and
• children older than 2 years with certain types of arthritis.

In some patients, ACTEMRA has been associated with drug-induced liver injuries, which can be serious, life-threatening or even fatal.

Before taking ACTEMRA, patients or their caregivers should talk to their healthcare professional if they have, or have had, liver problems. Before and/or during treatment, patients should have blood tests done to check their liver function.

If patients experience signs of liver injury such as loss of appetite, nausea and vomiting, fatigue, itching, dark urine, yellowing of skin and eyes, abdominal swelling, and/or pain in the upper-right abdomen, they or their caregivers should speak with their healthcare professional. Patients receiving ACTEMRA should also inform their healthcare professional if they experience any adverse effects.

Patients or their caregivers should contact their healthcare professional to obtain further information on this new safety information.

Information for healthcare professionals

Healthcare professionals are advised to:

• not recommend ACTEMRA in patients with active hepatic disease or hepatic impairment;
• not initiate treatment with ACTEMRA in patients with elevated blood liver enzyme levels (alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase) above 3 times the ULN;
• discontinue treatment with ACTEMRA in patients with elevated blood liver enzyme levels above 5 times the ULN;
• exercise caution when considering initiation of ACTEMRA treatment in patients with liver enzyme levels above 1.5 times the ULN;
• monitor liver function tests (LFTs) in patients with rheumatoid arthritis and giant cell arteritis every 4 to 8 weeks for the first 6 months of treatment, followed by every 12 weeks thereafter; 
• monitor LFTs in patients with polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis before starting treatment, at the time of the second ACTEMRA treatment, and every 2 to 4 weeks thereafter; and
• consult the approved Canadian Product Monograph for guidance on the recommended dose modifications in patients with elevated LFTs.

Action taken by Health Canada

Health Canada is currently assessing the risk of ACTEMRA-associated liver injury and is working with Hoffmann-La Roche Limited to update the Canadian Product Monograph to include this safety information. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification systemas well as social media channels including LinkedIn and Twitter.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare providers and consumers reporting adverse reactions and medical device incidents. Any case of hepatotoxicity or other serious or unexpected adverse reactions in patients receiving ACTEMRA should be reported to Hoffmann-La Roche Limited or Health Canada.

Hoffmann-La Roche Limited
Drug Safety Department
7070 Mississauga Road
Mississauga, Ontario, L5N 5M8
Toll free: 1-888-762-4388
Fax: 905-542-5864
E-mail: mississauga.drug_safety@roche.com

To correct your mailing address or fax number, contact Hoffmann-La Roche Limited.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Original signed by:

Loredana Regep, MD
Vice President, Medical & Regulatory Affairs
Hoffmann-La Roche Limited