Bedford Labs Initiates Nationwide Recall of Injectable Methotrexate

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

View Press Release online here- http://www.fda.gov/oc/po/firmrecalls/bedford12_05.html

Contact:
Marybeth C. McGuire, US Food and Drug Administration
(203) 798 - 4801

FOR IMMEDIATE RELEASE -- Ridgefield, CT - December 8, 2005 -- Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot# 859142, exp 09/07. Bedford Laboratories was informed by the manufacturer of the Methotrexate USP active drug substance (“ADS”) that the ADS used to manufacture Lot # 859142, contained low levels of ethylene glycol. Human use of preservative free Methotrexate formulations for intrathecal administration containing ethylene glycol is not permissible. Consumers that have received this product and have questions should contact their physicians.

Bedford Laboratories is working with the US FDA on this recall. No serious health or safety reports have been received that are attributed to this situation.

The prescription product was distributed throughout the United States in October and November 2005 to wholesalers and distributors, who further distribute the product to hospitals. Customers that have any vials of this one lot of Methotrexate for Injection have been instructed to discontinue distribution and use of this lot immediately and contact Bedford Laboratories Customer Service Department (1-800-562-4797) for a returned goods authorization. Consumers that have questions regarding this recall should also contact the Bedford Customer Service Department at 1-800-562-4797, between the hours of 8 a.m - 5 p.m (EST).

Bedford Laboratories supplies the US and International markets with multisource and specialty injectable products. Headquartered in Bedford, OH, Bedford Laboratories is a division of Ben Venue Laboratories, Inc., a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT, and a member of the Boehringer Ingelheim group of companies.

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The Choking Game

Thank you to Colerain Township Clerk Heather Harlow and Police Chief Steve Sarver for forwarding this information.

Date: 12/01/2005


Ohio Early Warning Alert

Ohio Resource Network for Safe and Drug Free Schools and Communities


The Choking Game

The "choking game" is a game played by teenagers, typically between the ages of 9 and 15, to create a rush or high without using drugs. These teens attempt to temporarily cut off the oxygen supply until they pass out.

Recent news reports suggest that though this game is not new, it has become more of a problem in recent weeks as teens in Ohio, Idaho, California, and North Carolina have died playing this game. It is difficult to determine the extent to which students are participating or the rate of death as it can easily be mislabeled as a suicide. The game, though nor always deadly, is particularly risky when the child tries to create the high when they are alone. It is estimated that 400-500 children die yearly from this risk behavior in the US. This figure does not include those participants injured or not injured

Street names include: space monkey, blackout, funky chicken, something dreaming game, flat liner, tingling, and suffocation roulette.

Signs that a child might be participating in the behavior: complaints of frequent headaches, marks on the neck of pinpoint blood marks on the neck, bloodshot eyes, the onset of aggressive behavior or aggravation, finding ropes, belts, or other objects with odd knots tied, and activity behind closed doors.

The American Psychological Association states that many times parents can offset dangerous risk taking behavior by simply being there and knowing what is going on in your teen's life. The APA recommends:

· Have a solid relationship with your teen and discuss issues that he faces.
· Be able to speak frankly with your teen about dangerous behaviors.
· Establish a pattern of chaperoning parties and asking where your teen is and with whom he is spending time.

Short Term Effect:
Choking can produce a drunken, light-headed "feeling" that is typically short-lived. Choking can also depress your heart rate, disturb your heart rhythm, and sap your body of oxygen. At the extreme, choking can result in sudden death due to lack of oxygen to the brain. Teens are killing brain cells every time they play this "game". They may also experience nausea, loss of appetite, coughing fits, and disorientation and loss of coordination, making it hard to walk or even stand for about 15 minutes after this dangerous risk behavior.
Long Term Effect:
This behavior can result in permanent brain damage and death.
Sources include reports from: http://kidshealth.org, www.cdsnews.com, www.wral.com, www.cnn.com, www.wkrc.com, www.msnbc.msn.com, http://lundiseases.about.com, www.parentnewsalert.com, and www.drphil.com.
For additional information on the above alert contact: The Ohio Resource Network for Safe and Drug Free Schools and Communities, P.O. Box 210109, 2624 Clifton Ave Cincinnati, Ohio 45221-0109 Phone # 1-800-788-7254 (opt#2).
Note: We would like to know what you were able to do by way of disseminating this alert information. Please reply with short descriptions of the dissemination (bullet format would be fine) or interesting stories related to this alert.

To participate in this OEWN initiative, visit www.ebasedprevention.org and fill out the OEWN registration form (listserv). Anyone in Ohio can report an issue to the Ohio Early Warning Network by calling the toll-free non-emergency InfoLine at 1-866-OhioEWN.

This alert is brought to you by the Ohio Department of Education, Safe and Drug Free Schools Program; the Ohio Department of Alcohol and Drug Addictions Services, Division of Prevention Services; the Ohio National Guard and the Ohio Resource Network for Safe and Drug Free Schools and Communities
The information appearing on this alert is presented for educational purposes only. While the information published on this site is believed to be accurate, it is not intended to substitute for your own informational gathering or professional medical advice.

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Square lights up the season

Downtown transforms into Bedford Falls for a 'Wonderful' time

By MIKE LESKO,
Bedford Sun Banner Staff Writer

Dec. 1, 2005

Horse-drawn carriage rides, ice sculptors and Santa Claus arriving on a train are some of the events that await people who visit downtown Bedford from noon to 4 p.m. Dec. 10.
It is part of "Christmas in Bedford Falls," a takeoff on the movie, "It's a Wonderful Life" starring Jimmy Stewart and Donna Reed. The film took place in the fictitious town of Bedford Falls.
"It is part of the hometown atmosphere of Bedford," Mayor Dan Pocek said. "It is one of the unique qualities that this city has over others."
Santa Claus will arrive at noon on a decorated train caboose before heading to Walgreens, 647 Broadway Ave., to greet children. Free photos with Santa will be taken from 1-4 p.m.
Some stores will offer free hot chocolate, candy, cookies, popcorn and gift certificates.
"We hope to bring more people back into Bedford," said Mike Guyer, president of the Bedford Chamber of Commerce, which is sponsoring the event.
Ice sculptors from Olmsted Ice Co. will carve Frosty the Snowman out of 20 blocks of ice, each weighing 150 pounds, at the city's municipal parking lot next to Romito's Smoke Shop, 703 Broadway Ave.
For the rest of the story, see your local Sun newspaper.
© 2005 Sun NewspapersGo to Sun Newspapers www.sunnews.com home page

Batten absent since election

by Mike Lesko,
Staff Writer: Bedford Sun Banner
Thursday December 1, 2005
http://www.sunnews.com

BEDFORD- Warner Batten is a no show.

Batten the newly elected Bedford Ward 1 councilman, has not attended any of City Council's three meetings since election day in which the city budget for the upcoming year was discussed.

His fellow council members are not pleased.

"I'm concerned that he hasn't been here," Vice Mayor Greg Pozar said.

"Warner is doing himself a disservice," Councilman Don Saunders said. "This is a critical part of the job. You need to be involved in these kind of discussions."

Batten, who defeated incumbent Ron Lisy in last month's general election, cannot vote because he will not be sworn into office until January."

Still, city leaders always invite newly elected council members to the weekly budget sessions in November and December.

Mayor Dan Pocek sent Batten a letter that read, in part: "It is customary to invite the newly elected officials to attend all work sessions of council prior to their being sworn in."

Batten said, "I got the letter saying I couldn't take part (in the decision making), but there is no particular reason (for not attending)."

Saunders said Batten said that if he couldn't have any input he wasn't coming.

"Granted, Warner can't vote, but he still is an integral part of it," Saunders said. "You can make comments. He may see points that were of a similar nature from the past where he could add insight. Everybody's opinion counts."

Pocek said he would ask Batten his opinion if he showed up, addind "It's simple protocol."

"Warner should know that," Councilwoman Marilyn Zolata added. "He saw a lot of people come on council in 20 years."

Batted, a 20-year council veteran, lost his seat four years ago to Lisy. Leading up to the last election, council members endorsed Lisy.

"Ron (Lisy) worked hard," Pocek said. "He has been a good member of council."

Batten said the lack of an endorsement by council did not affect his decision to stay away.

"That's the first time I've heard that," Batten said.

Told that other council members were annoyed by his absence, Batten said, "I can't help what they think."

"I might attend," Batten said Sunday night. "I don't know."

However, when Monday night rolled around, Batten was absent for the third consecutive week.

Contact Mile Lesko at Lesko_Mike@yahoo.com or call (216)986-5869







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