Latest Trasylol News

Study finds dangers in heart-surgery drug

February 7, 2007
LA Times
Denise Gellene

Raising fresh concerns about a widely used heart-surgery medicine, a study released Tuesday reported that the drug Trasylol increased patients' long-term risk of dying by nearly 50%.

An estimated 10,000 deaths worldwide could be avoided over the next five years if Trasylol were not used, according to the report in the Journal of the American Medical Assn.

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Bayer Hid The Results Of A Trasylol Related Study From The FDA

Source: Forbes Magazine

German drug giant Bayer failed to tell the U.S. Food and Drug Administration (FDA) of a study that connected a controversial heart surgery drug to dangerous side effects and death. The FDA had convened a panel of experts to evaluate the drug's safety. The company notified the FDA only after it was asked to do so by the scientist conducting the study. Bayer claims it "mistakenly" failed to tell the FDA about the evaluation of 67,000 hospital records regarding the drug Trasylol, which is used to prevent bleeding during open-heart surgery. According to a Public Health Advisory from the FDA, the new study linked Trasylol to increased risk of death, serious kidney damage, congestive heart failure, and strokes. William Hiatt, the University of Colorado vascular medicine specialist who chaired the panel, observed:

Why this wasn't made available at the panel meeting a week ago, I have no idea. It seems irregular.

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Latest Fosamax News

Dangers of Bisphosphonate Drugs

In a December 13, 2004 press release, doctors at Long Island Jewish Medical Center (LIJ) announced that they had discovered a link between bisphosphonate drugs and osteonecrosis of the jaw (ONJ), or literally, death of the jaw bone tissue.

Bisphosphonates are a class of drugs used to treat osteoporosis as well as prevent the metastasis of certain cancers into bones. They lessen the body’s ability to resorb bone, a process that naturally takes place in order to allow new bone cells (called osteoblasts) - to occupy the skeletal structure.

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Brittle truth of bone drugs

June 3, 2006
USA Today
By Kim Painter

Osteoporosis was once a little-known condition with few treatment options. Broken hips and hunched spines often were seen as inevitable signs of old age, especially for women.

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Fosamax, Merck's other drug problem

May 9, 2006
CNNMoney.com staff writer
By Aaron Smith

With thousands of Vioxx cases already in the courts, the drugmaker faces 15 suits over an osteoporosis drug blamed for rotting the jaw bone...

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Drug Linked to Death of Jawbone

March 13, 2005
USA Today
By Rita Rubin

Salvatore Ruggiero was puzzled.

Over a three-year period, the jaws of dozens of patients who had undergone oral surgery at his hospital had failed to heal properly. Part of the jawbone had died and become exposed.

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Latest Benzene News

FDA Finds Five Beverages Contain High Benzene Levels

By Jane Zhang
Wall Street Journal
May 20th, 2006

The Food and Drug Administration said Friday that five beverages among more than 100 tested by the agency had benzene levels that exceeded the government’s safety level for drinking water.

The FDA ordered the test in November after private-laboratory results showed some soft drinks contained benzene, a cancer-causing chemical that can form naturally under certain conditions.

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Latest Remicade News

Side-Effect Concerns Grow for Drugs to Treat Rheumatoid Arthritis

By SCOTT HENSLEY
May 17, 2006;

Two popular drugs that have transformed treatment of rheumatoid arthritis and other related diseases can also trigger unexpected serious infections -- and may contribute to cancer in some patients.

The risks of infection have been part of doctors' thinking about the drugs for years, while a possible link to cancer has been unclear. Now, however, researchers at the Mayo Clinic, analyzing existing clinical-trial data on Johnson & Johnson's Remicade and Abbott Laboratories' Humira, have come up with fresh estimates that suggest the incidences may be higher than previously thought. In particular, the findings show that the cancer risk may extend to solid tumors such as skin, lung and breast cancers, rather than limited to the lymphomas that had been the concern up to now.

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Latest Bausch & Lomb News

FDA Warns Bausch & Lomb On Lens-Solution Infections

By Patricia Kowsmann
November 7, 2006
Wall Street Journal

WASHINGTON -- Bausch & Lomb Inc. received a warning letter from the Food and Drug Administration, following an inspection of the company's Greenville, S.C., plant from March 22 through May 15. The inspection was in connection with reports that some users of Bausch & Lomb's ReNu with MoistureLoc contact-lens solution contracted a rare eye infection.

The Rochester, N.Y., company pulled the cleaning solution from world-wide markets in May after it said the product's formulation combined with certain use patterns likely contributes to an increased risk of Fusarium keratitis, a fungal eye infection that can lead to blindness.

The warning letter, dated Oct. 31 and addressed to company Chairman and Chief Executive Ronald L. Zarrella, reiterated preliminary findings the FDA reported in May. Like the preliminary report, the letter said the inspection didn't identify any conditions that contributed to or caused the infection, but it did find other problems.

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Some Bausch Solution Users Need Corneal Transplants After Infection

By JENNIFER CORBETT DOOREN
August 23, 2006

One-third of patients with serious eye infections associated with a Bausch & Lomb Inc. contact-lens solution have had or are scheduled to have corneal transplants to repair the eye's outer surface damaged by the infections, according to research led by the Centers for Disease Control and Prevention.

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Lens Care Solution is Faulted

By BARNABY J. FEDER
August 23, 2006

Federal disease control experts and leading eye doctors have formally concluded that ReNu With MoistureLoc from Bausch & Lomb was the only contact lens solution contributing to an outbreak of potentially blinding fungal eye infections earlier this year.

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Bausch & Lomb Solution Recall Exposes Risks for Eye Infections

By SYLVIA PAGÁN WESTPHAL
July 26, 2006

Two months ago, Bausch & Lomb Inc. issued a global recall of a new multipurpose contact-lens solution after it was linked to serious fungal eye infections in the U.S. and Asia. Within weeks, the company's U.S. market share for lens solutions dropped to 29%, down from 41%.

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Contact-Lens Hygiene Problems

By JON KAMP
June 28, 2006

Contact-lens wearers in Singapore who had serious fungal eye infections mainly used a contact-lens solution by Bausch & Lomb Inc. that it later pulled from the global market, and the majority of cases involved poor lens hygiene, a study found.

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May 17, 2006
LA Times
from Bloomberg News

Bausch & Lomb Inc. delayed telling U.S. regulators about 35 cases of a blinding eye infection in Singapore linked to its recalled ReNu with MoistureLoc contact lens cleaner, the Food and Drug Administration said Tuesday...

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An Important Message from Bausch & Lomb

Dear Loyal ReNu Consumer,

I want to report to you on an important action we are taking, why we are so, and what it means to you.

On April 13, we told you to stop using MoistureLoc contact lens solution. Today we have decided to recall this product throughout the world. We will not reintroduce it.

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Eye Fungus Strikes Some Europeans

By SYLVIA PAGÁN WESTPHAL
Wall Street Journal
May 4, 2006

Bausch & Lomb Inc. said "a handful" of cases of Fusarium keratitis eye infections among users of its ReNu contact-lens solution have been confirmed in Europe.

The cases represent the first time the company has acknowledged European incidents of the infection, which has struck Bausch solution users in Asia and the U.S. The outbreak has led the company to halt shipments of one of its products, ReNu with MoistureLoc, in several countries and to scrutinize a manufacturing plant in South Carolina for a possible explanation of the infection.

Bausch Delayed Case Reports, FDA Says

Bausch Was Told of Infections By Hong Kong Officials In Fall

April 27, 2006
Wall Street Journal
by Sylvia Pagan Westphal

Bausch & Lomb Inc. said Hong Kong health authorities notified it of eye infections in users of the company’s contact-lens solution in November 2005, several months before the company stopped selling the product there...

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Eye-Fungus Cases Reach 54; Probe Into Cause Continues

April Journal/LA Times

The Center for Disease Control and Prevention confirmed 24 new cases of a serious eye-fungus in the U.S., and health officials said it may be a month before they complete an investigation into whether Bausch & Lomb Inc.'s ReNu with MoistureLoc contact-lens solution is connected. The CDC reported 54 confirmed cases of Fusarium keratitis, up from 30 two weeks ago...

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More Infections Possibly Linked to Lens Cleaner

April Journal/LA Times
from Bloomberg News

U.S. Health officials said they were investigating an additional 67 cases of a potentially blinding eye infection that's been linked to a Bausch & Lomb Inc. cleaner for contact lenses withdrawn from stores last week.

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Bausch & Lomb Pulls Lens Cleaner

April 14, 2006
Los Angeles Times
Associated Press

After two days in a tailspin, shares of Bausch & Lomb Inc. edged up Thursday as federal officials investigated whether its newest contact lens solution was to blame for a fungal eye infection that can cause blindness...

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Bausch Won’t Ship Cleaner for Lenses Amid Infections

April 11, 2006
By SYLVIA PAGAN WESTPHAL and ANNA WILDE MATHEWS
from the Wall Street Journal Online

Bauch & Lomb Inc. will voluntarily stop shipping a contact-lens cleaning solution over concerns about an increasing number of rare and serious fungal eye infections tied to contact-lens use...

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Bausch & Lomb Offers Lens Solution Product Exchange In Singapore

March 13, 2006

SINGAPORE (Dow Jones)--U.S. eyecare-product maker Bausch & Lomb Inc. (BOL) Friday said it will offer a two-week voluntary product exchange program for ReNu contact lens solution users in Singapore...

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Bausch & Lomb to compensate Singapore customers

March 10, 2006

SINGAPORE, March 10 (Reuters) - Eye-care product maker Bausch & Lomb , which suspended sales of its ReNu contact lens solution in Singapore and Hong Kong last month, on Friday announced a compensation plan for customers in Singapore...

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Contact Lens Solution Linked to Eye Ailment

From Associated Press

Bausch & Lomb halts ReNu shipments after federal officials report a possible connection to a fungal infection. The shares fall after hours...

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Bausch & Lomb halts contact lens solution sales in Hong Kong

February 23, 2006

SINGAPORE (Reuters) - Eye-care product maker Bausch & Lomb has suspended sales of its ReNu contact lens solution in Hong Kong, less than a week after suspending sales in Singapore following reports of a series of eye infections...

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