McDonald's restaurants; Plasmin capsules; US FDA consumer updates

customer advisory regarding McDonald's
The following statement regarding McDonald's was published on page E-3 of the Thursday, June 19, 2008 issue of the Philippine Star newspaper: "Bring home any of the eight Kung Fu Panda characters with every purchase of your favorite Happy Meal." Were said characters tested and certified safe for children by the Bureau of Food and Drug or any other government agency?

customer advisory regarding Plasmin capsules
which were advertised on page 5 of the Saturday, June 21, 2008 issue of the Manila Bulletin newspaper. Said advertisement contained the following claims: "Clinical studies have proven the benefits of PLASMIN in patients with diabetes, heart
disease and stroke. Among them: reduction in numbness and dizziness, recovery of sensation and function of the arms and legs, improvement in breathing and speech, reduction in blood pressure and chest pain, reduction in blood sugar and
cholesterol levels and increased physical energy. PLASMIN . . . is free from side effects and can be safely combined with medications for hypertension, diabetes, stroke and heart disease. It is BFAD approved and USFDA certified." What proof,
if any, is there about said alleged clinical studies? Who paid for said alleged studies? Where and when, if any, were said studies conducted? How many people, if any, were the subjects of said alleged studies? Is there any proof that said alleged
studies were witnessed by independent, unbiased entities? PLASMIN is allegedly exclusively marketed by Sea Pharmacom Inc. whose address was identified as: 22/F, Suite 2208 Cityland 10 Tower II, 154 H.V. dela Costa St., Makati. Obtained a box of said products. Said box bears the words: "NO APPROVED THERAPEUTIC CLAIMS"


Time magazine web site
http://www.time.com/time/

http://www.fda.gov/consumer/consarchive.html#unapproved
All Consumer Updates

These articles were originally posted on the main Consumer Health Information page.


* Allergies
* Animal and Veterinary
* Asthma
* Bioterrorism
* Blood
* Buying Drugs Online
* Cancer
* Children's Health



* Cholesterol
* Contact Lenses
* Cosmetics
* Diabetes
* Dietary Supplements
* Drugs
* Emergency Preparedness
* Eye Health
* Flu
* Food



* Gene Therapy
* Generic Drugs
* Health Fraud
* Heart Health
* High Blood Pressure
* HIV/AIDS
* Imported Products
* Medical Devices
* Medication Errors
* Parkinson's Disease



* Personalized Medicine
* Psychiatric Conditions
* Radiation-Emitting Products
* Recalls
* Smoking Cessation
* Sun Safety
* Toothpaste
* Unapproved Drugs
* Vaccines
* Women's Health


Allergies

* Beware of Bug Bites and Stings (June 19, 2008) PDF
* New Type of Latex Glove Cleared (April 25, 2008)
* Stronger Warning Proposed for Xolair (April 17, 2007)
* Nonprescription Zyrtec-D for Allergies (Nov. 13, 2007)


Animal and Veterinary

* Heartworm Prevention in Your Pet (June 19, 2008) PDF
* Strengthening Beef Safety (April 25, 2008)
* Charges Filed in Contaminated Pet Food Scheme (Feb. 19, 2008)
* Pet Turtles: Cute But Contaminated with Salmonella (Jan. 25, 2008) PDF
* Purchasing Pet Drugs Online: Buyer Beware (Dec. 14, 2007) PDF
* Caution in Feeding Dogs Chicken Jerky (Sept. 28, 2007)
* Mars Petcare Recalls Dry Dog Food (Aug. 27, 2007)
* Safe Handling Tips for Pet Foods and Treats (Aug. 6, 2007)
* Botulism Risk from Castleberry Foods and Dog Food (July 24, 2007)
* Low Risk of Illness From Food Containing Melamine (May 14, 2007)
* FDA and USDA Investigate Tainted Animal Feed (April 30, 2007)
* Pet Turtles Pose Salmonella Risk (April 23, 2007)
* Contaminant Found in Second Pet Food Ingredient (April 23, 2007)
* Dog Treats May Present Health Hazard (April 17, 2007)
* Pet Food Recall: FDA's Ongoing Investigation (April 16, 2007) PDF


Asthma

* Albuterol Inhalers: Time to Transition (May 30, 2008) PDF
* FDA Safety Update: Asthma Medications (May 13, 2008) PDF
* Stronger Warning Proposed for Xolair (April 17, 2007)

Bioterrorism

* Building a Stronger Defense Against Bioterrorism (Aug. 29, 2007) PDF

Blood

* Have You Given Blood Lately? (Oct. 4, 2007)


Buying Drugs Online

* Beware of Online Cancer Fraud (June 17, 2008) PDF
* Internet Drugs Falsely Claim to Prevent, Treat STDs (March 12, 2008)
* The Possible Dangers of Buying Medicine Online (July 2, 2007) PDF


Cancer

* Beware of Online Cancer Fraud (June 17, 2008) PDF
* Warning for Regranex—Cream for Leg and Foot Ulcers (June 11, 2008)
* Serious Side Effects with Cancer Pain Drug (Sept. 28, 2007)
* Evista Approved for Reducing Breast Cancer Risk (Sept. 17, 2007)
* Test Detects the Spread of Breast Cancer (July 17, 2007)
* Test Determines Risk of Breast Cancer Returning (May 14, 2007)


Children's Health

* Beware of Bug Bites and Stings (June 19, 2008) PDF
* Nexium Approved for Children 1 to 11 Years Old (March 3, 2008)
* Pet Turtles: Cute But Contaminated with Salmonella (Jan. 25, 2008) PDF
* OTC Cough and Cold Products: Not For Infants and Children Under 2 Years of Age (Jan. 17, 2008)
* Use Caution with Cough and Cold Medicines for Children (Aug. 16, 2007)
* FDA 101: Infant Formula (Dec. 6, 2007)
* Workshop on Over-the-Counter Drug Use in Adolescents (Nov. 28, 2007)
* Should Your Child Be in a Clinical Trial? (Oct. 15, 2007)
* Lamisil Approved to Treat Scalp Ringworm in Children (Oct. 9, 2007)
* Nasal Influenza Vaccine Approved for Younger Children (Sept. 26, 2007)
* Unlawful Marketing of Hand Sanitizer for Children (Sept. 26, 2007)
* Warning about Baby’s Bliss Gripe Water (Sept. 21, 2007)
* Improving Medical Products for Children: Q & A with Dianne Murphy, M.D. (Sept. 20, 2007) PDF
* Drug Approved for Two Psychiatric Conditions in Children and Adolescents (Aug. 22, 2007)
* Warning for Nursing Mothers Taking Codeine (Aug. 17, 2007)
* A Parent's Guide to Kids' Vaccines (July 31, 2007) PDF
* Ad Spotlights Teen Abuse of Medicinal Drugs (July 18, 2007) PDF
* Spot the Block: Get Your Food Facts First (July 2, 2007) PDF
* New Ointment Treats Impetigo (May 21, 2007) PDF
* Pet Turtles Pose Salmonella Risk (April 23, 2007)


Cholesterol

* Controlling Cholesterol with Statins (May 16, 2008) PDF
* Ongoing Review of Cholesterol Drug Vytorin (Jan. 30, 2008)


Contact Lenses

* Improper Use of Decorative Contacts May Haunt You (Oct. 22, 2007) PDF
* Focusing on Contact Lens Safety (Nov. 1, 2007) PDF
* Recall: Complete MoisturePlus Contact Lens Solution (May 29, 2007)


Cosmetics

* Use Eye Cosmetics Safely (April 17, 2008) PDF
* How Safe are Color Additives? (Dec. 10, 2007) PDF
* Potentially Harmful "Cosmetic" Eye Product Seized (Nov. 19, 2007)
* Think Before You Ink: Are Tattoos Safe? (Dec. 6, 2007) PDF
* Removing Hair Safely (June 27, 2007) PDF


Diabetes

* Warning for Regranex—Cream for Leg and Foot Ulcers (June 11, 2008)
* Getting Up to Date on Glucose Meters (Nov. 1, 2007 - Updated March 18, 2008)
* Labeling Revised for Diabetes Drug Avandia (Nov. 15, 2007)
* Abbott Issues Correction for Certain Blood Glucose Meters (Sept. 13, 2007)
* Stronger Heart Warning on Diabetes Drugs (Aug. 15, 2007)
* Continuous 7-Day Glucose Monitoring System (June 4, 2007)
* New Safety Information on Diabetes Drug Rosiglitazone (May 25, 2007)


Dietary Supplements

* Warning About "Total Body" Liquid Supplements (April 1, 2008)
* Buying Fake ED Products Online (Jan 1, 2008) PDF
* Recent FDA Actions on Dietary Supplements (Nov. 7, 2007)
* Final Rule Promotes Safe Use of Dietary Supplements (June 22, 2007) PDF


Drugs

* Warning for Regranex—Cream for Leg and Foot Ulcers (June 11, 2008)
* Albuterol Inhalers: Time to Transition (May 30, 2008) PDF
* Contaminated Nipple Cream (May 30, 2008)
* FDA Takes Action Against Scientific Laboratories Inc. (May 28, 2008)
* Pregnant Women to Benefit from Better Information (May 28, 2008) PDF
* Controlling Cholesterol with Statins (May 16, 2008) PDF
* Bayer Removes Remaining Trasylol Stock (May 16, 2008)
* FDA Safety Update: Asthma Medications (May 13, 2008) PDF
* Drug Approved for Irritable Bowel Syndrome with Constipation (May 1, 2008)
* Combating Antibiotic Resistance (May 1, 2008) PDF
* Find the Latest Drug Product and Safety Information (April 11, 2008) PDF
* A Guide to Drug Safety Terms at FDA (April 11, 2008) PDF
* Use Caution with Over-the-Counter Creams, Ointments (April 1, 2008) PDF
* FDA 101: Medication Errors (March 14, 2008) PDF
* Internet Drugs Falsely Claim to Prevent, Treat STDs (March 12, 2008)
* Recent Generic Drug Approvals (March 3, 2008) PDF
* Nexium Approved for Children 1 to 11 Years Old (March 3, 2008)
* Medications for High Blood Pressure (Feb. 26, 2008) PDF
* "My Medicines" … This Brochure Can be a Lifesaver (Feb. 15, 2008) PDF
* Adverse Reactions Linked to Botox (Feb. 8, 2008)
* Celebrating the Successes of the Orphan Drug Act (Feb. 8, 2008)
* Serious Health Risks with Antiepileptic Drugs (Feb. 5, 2008)
* New Safety Warnings for Chantix (Feb. 5, 2008)
* FDA Approves Drug-Eluting Heart Stent (Feb. 5, 2008)
* Ongoing Review of Cholesterol Drug Vytorin (Jan. 30, 2008)
* Warning About Contaminated Pre-Filled Syringes (Jan. 29, 2008)
* OTC Cough and Cold Products: Not For Infants and Children Under 2 Years of Age (Jan. 17, 2008)
* Facts About Crohn's Disease (Updated May 2, 2008) PDF
* Buying Fake ED Products Online (Jan 1, 2008) PDF
* New Studies on Anemia Drugs' Risks (Jan 1, 2008)
* Safety Labeling Changes for Anemia Drugs (Nov. 8, 2007)
* Second Safety Warning on Fentanyl Skin Patch (Dec. 21, 2007)
* Warning Required for Nonoxynol 9 Over-the-Counter Contraceptives (Dec. 19, 2007)
* Labeling to Recommend Genetic Test for Patients with Asian Ancestry (Dec. 17, 2007)
* Workshop on Over-the-Counter Drug Use in Adolescents (Nov. 28, 2007)
* Early Communication for Smoking Cessation Product Chantix (Nov. 26, 2007)
* Labeling Revised for Diabetes Drug Avandia (Nov. 15, 2007)
* Nonprescription Zyrtec-D for Allergies (Nov. 13, 2007)
* Marketing Suspension of Trasylol for Heart Surgery (Nov. 5, 2007)
* Labeling Revised for Erectile Dysfunction Drugs (Oct. 29, 2007)
* Ensuring Potency of Thyroid Drugs (Oct. 12, 2007)
* FDA Action on Unapproved Hydrocodone Products (Oct. 12, 2007)
* Lamisil Approved to Treat Scalp Ringworm in Children (Oct. 9, 2007)
* Serious Side Effects with Cancer Pain Drug (Sept. 28, 2007)
* Thyroid Medications: Q & A with Mary Parks, M.D. (Jan. 2, 2008) PDF
* Side Effects of Sleep Drugs (July 31, 2007) PDF
* The Possible Dangers of Buying Medicine Online (July 2, 2007) PDF
* Strengthening Drug Safety (May 31, 2007) PDF
* Coping With Memory Loss (May 3, 2007) PDF
* FDA Launches Drug Safety Newsletter (Sept. 21, 2007)
* Evista Approved for Reducing Breast Cancer Risk (Sept. 17, 2007)
* FDA Aims to Upgrade Sunscreen Labeling (Aug. 23, 2007) PDF
* Drug Approved for Two Psychiatric Conditions in Children and Adolescents (Aug. 22, 2007)
* Warning for Nursing Mothers Taking Codeine (Aug. 17, 2007)
* Updated Labeling for Coumadin (Warfarin) (Aug. 17, 2007)
* Use Caution with Cough and Cold Medicines for Children (Aug. 16, 2007)
* Stronger Heart Warning on Diabetes Drugs (Aug. 15, 2007)
* Improving Access to HIV/AIDS Drugs Abroad (Aug. 13, 2007) PDF
* New HIV Drug for Adults (Aug. 7, 2007)
* Skin Patch Delivers Dementia Drug (Aug. 6, 2007)
* OTC Cough and Cold Products: Not For Infants and Children Under 2 Years of Age (Jan 17, 2008)
* Zelnorm Available Under Restricted Use (July 27, 2007)
* Ad Spotlights Teen Abuse of Medicinal Drugs (July 18, 2007) PDF
* Beware of Ticks … & Lyme Disease (June 27, 2007) PDF
* 6 Tips to Avoid Medication Mistakes (June 21, 2007) PDF
* Living with Fibromyalgia, First Drug Approved (June 21, 2007) PDF
* New Option for Rare Form of Hypertension (June 21, 2007)
* Medication Guides for Certain Prescription Products (June 6, 2007) PDF
* Warning: Toothpaste From China (June 1, 2007)
* Special Risks of Pharmacy Compounding (May 31, 2007) PDF
* Managing Drug Safety: Q&A With Paul Seligman, M.D. (May 31, 2007) PDF
* Unapproved Timed-Release Guaifenesin Products (May 31, 2007)
* New Ointment Treats Impetigo (May 21, 2007)
* Violations Prove Costly to Maker of OxyContin (May 21, 2007)
* PharmaFab Agrees to Stop Selling Unapproved Drugs (May 21, 2007)
* Neupro Patch for Parkinson's Approved (May 14, 2007)
* The Benefits and Risks of Pain Relievers: Q & A on NSAIDs with Sharon Hertz, M.D. (April 26, 2007) PDF
* Risks for ADHD Drugs Outlined in Patient Guides (April 23, 2007)
* Withdrawal of Parkinson's Treatment—Pergolide (April 17, 2007)
* Stronger Warning Proposed for Xolair (April 17, 2007)


Emergency Preparedness

* Prepare for Hurricane Season: Advice From FDA (May 23, 2007) PDF


Eye Health

* Use Eye Cosmetics Safely (April 17, 2008) PDF
* Improper Use of Decorative Contacts May Haunt You (Oct. 22, 2007) PDF
* Focusing on Contact Lens Safety (Nov. 1, 2007) PDF
* First LASIK Device for Monovision (July 13, 2007)
* Recall: Complete MoisturePlus Contact Lens Solution (May 29, 2007)


Flu

* A Ready Supply of Influenza Vaccine (Oct. 23, 2007) PDF
* Nasal Influenza Vaccine Approved for Younger Children (Sept. 26, 2007)
* A Parent's Guide to Kids' Vaccines (July 31, 2007) PDF
* First 'Bird Flu' Vaccine for Humans Approved (April 30, 2007)





Food

* Red Tomato Warning Expanded Nationwide (June 10, 2008)
* Warning on Certain Types of Raw Red Tomatoes (June 5, 2008)
* Enforcement Actions for Food Safety Violations (May 28, 2008)
* Start at the Store: 7 Ways to Prevent Foodborne Illness (May 13, 2008) PDF
* Strengthening Beef Safety (April 25, 2008)
* Salmonella Illnesses May be Linked to Recalled Cereal (April 14, 2008)
* Food Label Helps Consumers Make Healthier Choices (March 27, 2008) PDF
* Problems Digesting Dairy Products? (March 25, 2008) PDF
* FDA Warns Not to Eat Cantaloupe from Honduran Grower (March 22, 2008)
* New Era Recall Includes More Canned Vegetables (Feb. 8, 2008)
* Botulism Risk from Canned Green Beans (Dec. 26, 2007)
* Lead Warning for Swad Brand Sindoor Powder (Dec. 17, 2007)
* How Safe are Color Additives? (Dec. 10, 2007) PDF
* FDA 101: Infant Formula (Dec. 6, 2007)
* Fortify Your Knowledge About Vitamins (Nov. 19, 2007) PDF
* Food Safety Tips for Healthy Holidays (Nov. 13, 2007) PDF
* How the FDA Works to Keep Produce Safe (April 17, 2007)
* Warning about Organic Pastures Raw Cream (Sept. 21, 2007)
* Warning about Baby's Bliss Gripe Water (Sept. 21, 2007)
* Promoting Food Safety in Puerto Rico (Sept. 17, 2007)
* Warning on Raw Oysters from Washington State (Aug. 13, 2007)
* Avoid Red Yeast Rice Promoted for High Cholesterol (Aug. 10, 2007)
* Botulism Risk From Canned French Cut Green Beans (Aug. 3, 2007)
* Botulism Risk from Castleberry Foods and Dog Food (July 24, 2007)
* Tainted Veggie Booty Snack Food (July 16, 2007)
* FDA's Watchful Eye on the American Diet (July 9, 2007) PDF
* Spot the Block: Get Your Food Facts First (July 2, 2007) PDF
* How FDA Regulates Seafood: FDA Detains Imports of Farm-Raised Chinese Seafood (June 28, 2007) PDF
* FDA's Standards for High Quality Foods (June 18, 2007) PDF
* CARVER + Shock: Enhancing Food Defense (June 15, 2007) PDF
* FDA Launches Tomato Safety Initiative (June 14, 2007)
* Recognizing Recalled Foods (June 14, 2007) PDF
* Warning on Mislabeled Monkfish (May 29, 2007)
* Barbecue Basics: Tips to Prevent Foodborne Illness (May 22, 2007) PDF
* Hog Meat Safe to Eat, Testing Shows (May 16, 2007)
* Beware of Botulism Risk from Certain Olives (April 18, 2007)
* Animal Cloning and Food Safety (Jan. 15, 2008) PDF
* Possible Botulism Risk: New Era Expands Recall (Jan. 22, 2008)


Gene Therapy

* FDA 101: Human Gene Therapy (Feb. 26, 2008) PDF
* Human Gene Therapies: Novel Product Development; Q & A with Celia M. Witten, Ph.D, M.D. (Oct. 15, 2007)
* FDA Releases Statement on Gene Therapy Trial (July 27, 2007)


Generic Drugs

* Recent Generic Drug Approvals (March 3, 2008) PDF
* New Generic Drug Program: Q & A with Gary J. Buehler (Oct. 4, 2007)
* New Initiative to Improve Availability of Generics (Oct. 4, 2007)


Health Fraud

* Beware of Online Cancer Fraud (June 17, 2008) PDF
* Civil Penalties Sought Against Maker of Hearing Aid (April 4, 2008)
* Buying Fake ED Products Online (Jan 1, 2008) PDF
* “Raw Deal” Targets Illegal Steroids (Oct. 4, 2007)
* Unlawful Marketing of Hand Sanitizer for Children (Sept. 26, 2007)
* FDA Warns About Unapproved Product, Melanotan II (Sept. 5, 2007)
* Avoid Red Yeast Rice Promoted for High Cholesterol (Aug. 10, 2007)


Heart Health

* Controlling Cholesterol with Statins (May 16, 2008) PDF
* Bayer Removes Remaining Trasylol Stock (May 16, 2008)
* Devices That Keep the Heart Beating (Updated May 2, 2008) PDF
* Device Identifies Fatty Deposits in Coronary Arteries (May 1, 2008)
* FDA Approves Drug-Eluting Heart Stent (Feb. 5, 2008)
* Marketing Suspension of Trasylol for Heart Surgery (Nov. 5, 2007)


High Blood Pressure

* Medications for High Blood Pressure (Feb. 26, 2008) PDF
* New Option for Rare Form of Hypertension (June 21, 2007)


HIV/AIDS

* Vital Facts About HIV Home Test Kits (Jan. 29, 2008) PDF
* Improving Access to HIV/AIDS Drugs Abroad (Aug. 13, 2007) PDF
* New HIV Drug for Adults (Aug. 7, 2007)


Imported Products

* Recognizing Potentially Unsafe Imported Toothpastes (Oct. 15, 2007)
* Ensuring the Safety of Imported Products: Q & A with Deborah Ralston (Oct. 12, 2007) PDF


Medical Devices

* Devices That Keep the Heart Beating (Updated May 2, 2008) PDF
* Device Identifies Fatty Deposits in Coronary Arteries (May 1, 2008)
* New Type of Latex Glove Cleared (April 25, 2008)
* Civil Penalties Sought Against Maker of Hearing Aid (April 4, 2008)
* Taking a Close Look at Ultrasound (March 24, 2008) PDF
* Avoid Fetal "Keepsake" Images, Heartbeat Monitors (March 24, 2008) PDF
* Getting Up to Date on Glucose Meters (Updated March 18, 2008)
* Denture Cleansers: Allergic Reactions and Misuse (March 7, 2008) PDF
* Icy Hot Heat Therapy Products Recalled (Feb. 19, 2008)
* FDA Approves Drug-Eluting Heart Stent (Feb. 5, 2008)
* Vital Facts About HIV Home Test Kits (Jan. 29, 2008) PDF
* First Quick Test for Deadly, Drug-Resistant MRSA Bacterium (Jan. 10, 2008)
* Use Your Microwave Safely (Nov. 21, 2007) PDF
* Getting Up to Date on Glucose Meters (Nov. 1, 2007)
* Improper Use of Decorative Contacts May Haunt You (Oct. 22, 2007) PDF
* Focusing on Contact Lens Safety (Nov. 1) PDF
* Recall: Complete MoisturePlus Contact Lens Solution (May 29)
* Medtronic Recalls Sprint Fidelis Cardiac Leads: Questions and Answers for Consumers (Oct. 15, 2007)
* Abbott Issues Correction for Certain Blood Glucose Meters (Sept. 13, 2007)
* The Skinny on Liposuction (Aug. 20, 2007) PDF
* First Artificial Neck Disc Approved (July 18, 2007)
* First Quick Test for Malaria (June 27, 2007)
* Beware of Ticks … & Lyme Disease (June 27, 2007) PDF
* Respirators for Public Health Emergencies (June 12, 2007) PDF
* Rapid Response Helps Save Limbs (May 14, 2007) PDF
* Rapid Test Detects Viral Meningitis (May 14, 2007)
* FDA Seizes Implantable Devices (April 30, 2007)


Medication Errors

* Pregnant Women to Benefit from Better Information (May 28, 2008) PDF
* FDA 101: Medication Errors (March 14, 2008) PDF


Parkinson's Disease

* Neupro Patch for Parkinson's Approved (May 14, 2007)
* Withdrawal of Parkinson's Treatment—Pergolide (April 17, 2007)


Personalized Medicine

* How FDA Advances Personalized Medicine (Sept. 5, 2007) PDF
* FDA Readies for More 'Nanoscale' Challenges (July 25, 2007) PDF


Psychiatric Conditions

* Drug Approved for Two Psychiatric Conditions in Children and Adolescents (Aug. 22, 2007)
* New Warnings Proposed for Antidepressants (May 3, 2007)


Radiation-Emitting Products

* Use Your Microwave Safely (Nov. 21, 2007) PDF


Recalls

* Salmonella Illnesses May be Linked to Recalled Cereal (April 14, 2008)
* FDA Warns Not to Eat Cantaloupe from Honduran Grower (March 22, 2008)
* New Era Recall Includes More Canned Vegetables (Feb. 8, 2008)
* Possible Botulism Risk: New Era Expands Recall (Jan. 22, 2008)
* Botulism Risk from Canned Green Beans (Dec. 26, 2007)
* FDA 101: Product Recalls - From First Alert to Effectiveness Checks (Dec. 31, 2007) PDF
* Merck Recalls Certain Lots of Haemophilus influenza type b (Hib) Vaccine (Dec. 13, 2007)
* Warning about Organic Pastures Raw Cream (Sept. 21, 2007)
* Warning about Baby’s Bliss Gripe Water (Sept. 21, 2007)
* Mars Petcare Recalls Dry Dog Food (Aug. 27, 2007)
* Botulism Risk From Canned French Cut Green Beans (Aug. 3, 2007)
* Botulism Risk from Castleberry Foods and Dog Food (July 24, 2007)
* Recall: Complete MoisturePlus Contact Lens Solution (May 29, 2007)
* Beware of Botulism Risk from Certain Olives (April 18, 2007)
* Dog Treats May Present Health Hazard (April 17, 2007)
* Pet Food Recall: FDA's Ongoing Investigation (April 16, 2007) PDF


Smoking Cessation

* New Safety Warnings for Chantix (Feb. 5, 2008)


Toothpaste

* Warning: Toothpaste From China (June 1, 2007)
* Recognizing Potentially Unsafe Imported Toothpastes (Oct. 15, 2007)


Unapproved Drugs

* FDA Action on Unapproved Hydrocodone Products (Oct. 12, 2007)
* Unapproved Timed-Release Guaifenesin Products (May 31, 2007)
* PharmaFab Agrees to Stop Selling Unapproved Drugs (May 21, 2007)


Sun Safety

* Beware of Bug Bites and Stings (June 19, 2008) PDF
* FDA Aims to Upgrade Sunscreen Labeling (Aug. 23, 2007) PDF
* Sun Safety: Save Your Skin! (July 24, 2007) PDF


Vaccines

* Merck Recalls Certain Lots of Haemophilus influenza type b (Hib) Vaccine (Dec. 13, 2007)
* Wider Age Range for Meningitis Vaccine (Oct. 29, 2007)
* A Ready Supply of Influenza Vaccine (Oct. 23, 2007) PDF
* Precautions to Prevent Rabies (Oct. 22, 2007)
* Nasal Influenza Vaccine Approved for Younger Children (Sept. 26, 2007)
* FDA Approves New Smallpox Vaccine (Sept. 4, 2007)
* A Parent's Guide to Kids' Vaccines (July 31, 2007) PDF
* First "Bird Flu" Vaccine for Humans Approved (April 30, 2007)


Women's Health

* Contaminated Nipple Cream (May 30, 2008)
* Pregnant Women to Benefit from Better Information (May 28, 2008) PDF
* Drug Approved for Irritable Bowel Syndrome with Constipation (May 1, 2008)
* Use Eye Cosmetics Safely (April 17, 2008) PDF
* Update to Label on Birth Control Patch (Jan. 22, 2008)
* Bio-Identicals: Sorting Myths from Facts (April 8, 2008) PDF
* Warning Required for Nonoxynol 9 Over-the-Counter Contraceptives (Dec. 19, 2007)
* Evista Approved for Reducing Breast Cancer Risk (Sept. 17, 2007)
* Test Detects the Spread of Breast Cancer (July 17, 2007)
* First Contraceptive for Continuous Use (May 29, 2007)
* Test Determines Risk of Breast Cancer Returning (May 14, 2007)



http://www.fda.gov/consumer/features/contactlens1107.html
US FDA Focusing on Contact Lens Safety

* Types of Contact Lenses
* Getting a Prescription
* Tips for Buying
* Proper Care Required
* Decorative Contact Lenses
* How to Report Problems
* For More Information

More than 30 million Americans use contact lenses, according to the Contact Lens Council. In addition to offering flexibility, convenience, and a "no-glasses" appearance, "contacts" help correct a variety of vision disorders, including nearsightedness, farsightedness, astigmatism, and poor focusing with reading material.

But contact lenses also present potential risks. "Because they are worn directly on the eye, they can lead to conditions such as eye infections and corneal ulcers," says James Saviola, Branch Chief for FDA's Division of Ophthalmic and Ear, Nose and Throat Devices. "These conditions can develop very quickly and can be very serious. In rare cases, they can lead to blindness."

Best strategies for contact lens safety involve maintenance, cleanliness, and learning as much about it as you can.

FDA regulates contact lenses through the Federal Food, Drug, and Cosmetic Act. The agency also regulates contact lenses intended for vision correction as prescription devices, and has jurisdiction over contact lens solution.

The Federal Trade Commission (FTC) regulates device advertising and marketing practices that cause or are likely to cause substantial consumer injury.
Types of Contact Lenses

General categories

* Soft Contact Lenses are comfortable and made of flexible plastics that allow oxygen to pass through to the cornea. Users get accustomed to wearing them within several days. Most soft-contact wearers are prescribed some type of frequent replacement schedule. An example of this is a schedule that calls for the lenses to be replaced with new ones after two weeks of use.
* Rigid Gas Permeable (RGP) Lenses are durable, resist deposit buildup, and generally allow for clear, crisp vision. They last longer than soft contacts, and also are easier to handle and less likely to tear. However, they may take a few weeks of getting used to.

Other types

* Extended Wear Contacts are good for overnight or continuous wear ranging from one to six nights, or up to 30 days. It's important for the eyes to have a rest without lenses for at least one night following each scheduled removal.
* Disposable (Replacement Schedule) Contacts. To FDA, “disposable” means "to be used once and discarded." However, some soft contacts referred to as “disposable” by sellers are actually worn on a frequent replacement schedule--for two weeks, for example--that calls for them to be disinfected between uses.
* Lenses Designed for "Ortho-K." Orthokeratology (Ortho-K) is a lens-fitting procedure that uses specially designed RGP contact lenses to change the curvature of the cornea to temporarily improve the eye's ability to focus. It's primarily used for the correction of nearsightedness. The most common type is overnight Ortho-K, and FDA requires that eye care professionals be trained and certified before using them in their practices.
* Decorative (Plano) Contacts. FDA has often warned people about the risks associated with wearing these lenses without appropriate professional involvement. They don't correct vision and are intended solely to change the appearance of the eye.


Getting a Prescription

When you get an eye exam, you have the right to get a copy of your prescription. You can then use it at another vendor or to order contact lenses on the Internet, over the phone, or by mail.

As per FTC regulations, a prescription should contain sufficient information for a seller to completely and accurately fill the prescription: examination date, date you received the prescription after a contact lens fitting, expiration date, and the name, address, phone and fax number of the prescribing professional.

The prescription should also offer information about material and/or manufacturer, base curve or appropriate designation, and diameter (when appropriate) of the prescribed contact lens.


Tips for Buying

With a valid prescription, it is possible to purchase contact lenses from stores, the Internet, over the phone or by mail. But be extremely cautious when buying contacts from someone other than your eye care professional.

Contact lenses are NOT over-the-counter devices. Companies that sell them as such are misbranding the device and violating FTC regulations by selling you contact lenses without having your prescription.

Avoiding problems

* Make sure your prescription is current. Don't order with an expired prescription, and don't stock up on lenses right before the prescription is about to expire. If you haven't had your eyes checked within the last year or two, you may have eye problems that you are not aware of, or your lenses may not correct your vision well.
* Order from a supplier that you are familiar with and know is reliable.
* Request the manufacturer's written patient information for your contact lenses. It will give you important risk/benefit information and instructions for use.
* Beware of attempts to substitute a different brand than you presently have. There are differences in the water content and shape among the brands. The correct choice of which lens is right for you should be based only on an examination by your eye care professional.
* Make sure that you get the exact brand, lens name, power, sphere, cylinder (if any), axis (if any), diameter, base curve, and peripheral curves (if any) noted on the prescription. If you think you've received an incorrect lens, check with your eye care professional. Don't accept a substitution unless your eye care professional approves it.

Proper Care Required

Contact lens users run the risk of infections such as pink eye (conjunctivitis), corneal abrasions, and eye irritation. A common result of eye infection is corneal ulcers, which are open sores in the outer layer of the cornea. Many of these complications can be avoided through everyday care of the eye and contact-lenses.

To reduce your chances of infection

* Replace your contact lens storage case every 3-6 months.
* Clean and disinfect your lenses properly.
* Remove your contact lenses before swimming.
* Always use fresh contact lens solution. Never reuse the lens solution.
* Avoid non-sterile water. Distilled water and tap water are not sterile and should not be used.
* Never use homemade saline solution, as tap and distilled water are not sterile.
* Never transfer contact lens solutions into smaller travel size containers. This can affect sterility and may also leave you open to accidentally applying a harmful liquid to your eyes.
* Never put your lenses in your mouth; saliva is not sterile.

"Also, any lenses worn overnight increase your risk of infection," says Saviola.

"This is because contact lenses stress the cornea by reducing the amount of oxygen to the eye. They can also cause microscopic damage to the surface of the cornea, making it more susceptible to infection."

Never ignore symptoms of eye irritation or infection that may be associated with wearing contact lenses. The symptoms include discomfort, excess tearing or other discharge, unusual sensitivity to light, itching, burning, gritty feelings, unusual redness, blurred vision, swelling and pain.

If you experience any of these symptoms

* Remove your lenses immediately and keep them off.
* Get in touch with your eye care professional immediately.
* Keep the lenses. They may help your eye care professional determine the cause of your symptoms.
* Report serious eye problems associated with your lenses to FDA's MedWatch reporting program.


Decorative Contact Lenses

Every year, the approach of Halloween heightens fears at FDA that consumers will harm their eyes with unapproved decorative contact lenses. These are lenses that some people use to temporarily change their eye color or to make their eyes look weird--perhaps giving them an "eye-of-the-tiger" look.

"Although unauthorized use of decorative contact lenses is a concern year-round, Halloween is the time when people may be inclined to use them, perhaps as costume accessories," says Saviola.

The problem is not that people use decorative, non-corrective lenses. It's that many go about it the wrong way, which is dangerous.

Prescription required
Just like their corrective counterparts, decorative contacts--sometimes called plano, zero-powered or non-corrective lenses--are regulated by FDA.

"What troubles us is when they are bought and used without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care," says Saviola. "This can lead to significant risks of eye injuries, including blindness."

FDA is aware that consumers without valid prescriptions have bought decorative contact lenses from beauty salons, record stores, video stores, flea markets, convenience stores, beach shops and the Internet.

Recent legislation has made it illegal to market decorative contact lenses as over-the-counter products.

Unauthorized contact lenses of all types present risks to the eye that include corneal ulcers, corneal abrasion, vision impairment, and blindness.

If you want decorative contacts

* Get an eye exam from a licensed eye care professional, even if you feel your vision is perfect.
* Get a valid prescription that includes the brand and lens dimensions.
* Buy the lenses from an eye care professional or from a vendor who requires that you provide prescription information for the lenses.
* Follow directions for cleaning, disinfecting, and wearing the lenses, and visit your eye care professional for follow-up eye exams.


For More Information

Everyday Eyecare Tips
www.fda.gov/cdrh/contactlenses/eyecare.html

CDRH's Contact Lenses Web Site
www.fda.gov/cdrh/contactlenses/index.html

Date Posted: November 1, 2007