E-mail, calls pour into FDA for Lotronex 

By BILL KRUEGER, Staff Writer 

They called the government. They called Glaxo
Wellcome. They even tried to get to Oprah.
They want their Lotronex back.

Women who consider Lotronex a miracle drug
expressed their dismay Wednesday at the
news that Glaxo Wellcome had decided to pull
Lotronex off the market because of safety
concerns raised by the U.S. Food and Drug
Administration.

Lotronex was the first new drug in decades to
treat irritable bowel syndrome, which afflicts as
many as 52 million people in the United
States. Although irritable bowel syndrome afflicts both men and
women, Lotronex had been shown to be effective only for women.

After Lotronex hit the market in March, many women said it stopped
their chronic abdominal pain, persistent diarrhea and unpredictable
sense of urgency to go to the bathroom.

"It truly gave me back my life," said Colleen Condron, a public radio
manager in Fort Wayne, Ind., who has suffered from irritable bowel
syndrome for 15 years. 

Condron said she cried after hearing that Glaxo was pulling the drug
off the market. She sent e-mail messages to Glaxo and the FDA.
She said she has enough Lotronex to last her a couple of months.

Ramona DuBose, a Glaxo spokeswoman, said the company's
customer response center in Research Triangle Park received from
350 to 400 calls an hour Wednesday from distraught Lotronex users.

Since Lotronex became available in March, more than 450,000
prescriptions had been filled. FDA officials, though, were concerned
about reports of five deaths and dozens of instances of severe health
consequences in people taking Lotronex.

Dr. Victor Raczkowski, deputy director of the FDA division that
approved Lotronex, said the agency received many phone calls and
e-mail messages Wednesday. 

"It's a very difficult situation that these patients find themselves in," he
said. "On the other hand, there have been patients who have been
injured in association with the use of Lotronex."

Karen Kenney, a bartender from Northwood, N.H., even sent an
e-mail message to Oprah Winfrey to encourage her to do a show
about irritable bowel syndrome.

"Lotronex gave me my freedom back," she said. "It gave me my life
back."

Kenney said she has nine tablets left. She is going to save them for
a Christmas vacation in Florida.

"At least when I'm here," she said, "I know where all the bathrooms
are." 

Staff writer Bill Krueger can be reached at 829-4522 or bkrueger@nando.com