At least a half million liquid-filled baby teethers distributed in the United States and Canada have been recalled because of a possible bacterial contamination that could cause serious illness, the Associated Press reported.
The liquid in six types of teethers could be contaminated with the Pseudomonas aeruginosa or the Pseudomonas putida bacteria, according to The First Years Inc., of Massachusetts. If the teether is punctured and the liquid ingested, the bacteria can cause serious illness in children, although no illnesses have been reported.
"FDA would like to caution consumers that Pseudomonas aeriginosa is a bacteria that can cause serious illness, particularly in people with compromised immune systems and in infants who are still developing their immunity, as well as children who are born with immune deficiencies," FDA spokeswoman Julie Zawisza told the wire service Friday.
Three of the products are adorned with popular cartoon characters. The Disney Days of Hunny Soft Cool Ring Teether, bearing style number Y1447, and the Disney Soft Cool Ring Teether, bearing style number Y1470 or Y1490, feature Winnie-the-Pooh characters. The Sesame Beginnings Chill and Chew Teether, style number Y3095, features Sesame Street characters.
The other teethers recalled are The First Years Cool Animal Teether (style number Y1473) and The First Years Floating Friends Teether (style number Y1474), which feature fish and other animal graphics.
Major retailers, including grocery, drug and specialty stores, sold the product nationwide and in Canada from July 2005 through January 2006.
New Angina Drug to Hit Market in March
A drug that eases the agonizing pain that can grip angina sufferers when their hearts don't get enough oxygen has been given the government's blessing, the Associated Press reported.
The U.S. Food and Drug Administration approved ranolazine for use in angina patients, agency spokeswoman Laura Alvey told the wire service on Friday. The drug is approved for patients who take calcium channel blockers, beta blockers or nitroglycerin, according to CV Therapeutics Inc. The California company hopes to begin marketing the drug as Ranexa in March.
More than 6 million Americans have angina; Ranexa allows the heart to pump more efficiently without the need for more oxygen, the AP reported.
Current drugs for angina either increase the supply of oxygen-bearing blood or reduce the heart's demand for oxygen. Ranexa relaxes contracted heart muscle, Dr. Louis Lange, chairman and chief executive officer of CV Therapeutics, told the AP. That returns blood flow to normal levels, relieving the pain that accompanies it, Lange added.
The drug will be available as an extended-release tablet.
The European Medicines Agency in October demanded further trials of Ranexa before it would consider approving the drug.
Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration has warned.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported Thursday.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a news conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
Texas Attorney Must Turn Over Damaging Guidant Documents
A Texas attorney has been ordered by the U.S. Justice Department to hand over documents indicating the company continued selling some of its heart defibrillators after knowing they could malfunction, the Associated Press reported Saturday.
As part of the government's investigation into the Indianapolis-based company, attorney Bob Hilliard must relinquish notes and PowerPoint slides he obtained during preparations for an upcoming product liability trial in Texas, according to the AP.
Included in the documents are notes from Fred McCoy, president of Guidant's cardiac rhythm management division, that show the company decided to keep selling defibrillators McCoy described as having sporadic "life-threatening" defects.
Guidant spokesman Steve Tragash declined to comment, and Assistant U.S. Attorney Robert Lewis did not return a phone call seeking comment on the subpoena, the AP reported.
Hilliard represents about 70 patients who are suing Guidant. The first trial, scheduled to begin Feb. 20, involves two patients with faulty defibrillators.
In the last six months, Guidant has recalled or issued safety advisories for about 88,000 defibrillators, and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices.
Illinois Pharmacists Sue Drug Store Chain Over Morning-After Pill Policy
Four Illinois pharmacists have sued Walgreen Drug Stores, claiming they were fired illegally after they refused to sign a pledge promising to dispense the morning-after birth-control pill, the Associated Press reported Friday.
Walgreen Co. is accused of violating the Illinois Health Care Right of Conscience Act, according to the AP. The American Center for Law and Justice, a public-interest group founded by evangelist Pat Robertson, is representing the pharmacists.
A new state rule requires pharmacies that sell federally approved contraceptives to fill prescriptions for emergency birth control "without delay" if they have the medication in stock. The rule is being challenged in federal court.
In response, Deerfield-based Walgreen asked its pharmacists to promise in writing that they would fill prescriptions for contraceptives such as the morning-after pill. The plaintiffs were suspended indefinitely without pay when they refused to sign the pledge in November.
"It couldn't be any clearer," ACLJ senior counsel Francis J. Manion told the wire service. "In punishing these pharmacists for asserting a right protected by the Conscience Act, Walgreens broke the law."
Walgreen spokesman Michael Polzin said the company had no legal choice but to comply with the new regulations.
Food Fact: Kernels of wisdom.
The secret to tastier corn: Know exactly how long to cook it. Sweet and tender corn should be cooked in boiling water for no more than 1 or 2 minutes. For best flavor, cook corn the same day it's picked. It's naturally tasty - try it without butter to avoid added fat.There's nothing better than eating corn-on-the-cob on a summer's night. It's good for the soul and the body too. One ear's worth of kernels contains 85 calories and 3 grams fiber. Yellow corn contains lutein, a plant pigment that helps protect your eyes from macular degeneration. Hominy is corn that has been treated with an alkali to remove the hulls. The process boosts the availability of the niacin in corn as a nutrient.
Fitness Tip of the day: Find the right activity.
Answers to three questions will tell you if your exercise program is right for you. Try different activities, and ask yourself : Do I look forward to this? Do I enjoy doing it? Do I feel good afterward? If you answer yes to all three, it's an activity you'll probably keep doing. Remember, no exercise program will work for long if you have to force yourself to do it.
FAQ of the day: Do I need more soy if I'm menopausal?
There's some evidence that soy's isoflavones may help reduce hot flashes. More important is the benefit that soy foods rich in soy protein and isoflavones have on osteoporosis and heart disease. Like estrogen itself, soy's isoflavones help keep bones strong. You may want to take a soy protein isolate powder containing isoflavones daily to help prevent osteoporosis and lower blood cholesterol. With diet and exercise, you can greatly reduce your risk of heart disease after menopause, even without hormone replacement therapy.