Do I have a case?


What is Lotronex?

What is the problem?

Who is responsible?

What is being done?

What can you do?


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Who is Responsible?

Lotronex maker GlaxoSmithKline and the U.S. Food and Drug Administration have been blamed for rushing the drug onto the market despite its known side effects. Then, after a temporary recall, pushing the drug back into circulation without properly protecting consumers.

Three months after Lotronex' launch in February 2000, British medical journal The Lancet published a scathing editorial branding the FDA "a servant of the industry" for the way it approved the drug.

The agency was compromised both by the funding it receives from drug makers and by pressure from Congress to favor the industry, author Richard Horton said.

Serious side effects were known before the FDA approved Lotronex, and the agency brushed aside the safety concerns of its own scientists, he said.

Patients in Lotronex studies suffered from severe constipation and from ischemic colitis, caused by restricted blood flow to the bowel. After the drug's approval, further cases of the two potentially fatal side effects forced its recall nine months later.



Other critics blasted the FDA for speeding Lotronex through a fast-track approval process.

The drug is used to treat irritable bowel syndrome (IBS), which the agency classifies as a serious condition. Because of that status, Lotronex went through an expedited approval process, which may have led investigators to ignore danger signals about its safety.
But critics said that IBS, though debilitating, isn't dangerous enough for "serious condition" status. IBS does not lead to surgery or cause death.


Lotronex sales literature contained several misleading and unsuppor
ted claims, according to an April 2000 warning from the FDA to GlaxoSmithKline (then Glaxo Wellcome).

In one instance, "the implication that Lotronex would improve the quality of life of IBS patients is unsubstantia
ted," according to the warning.

In another, the drug maker buries important risk information within long bodies of text," the FDA said.

"Important warnings such as 'Lotronex should be discontinued in patients experiencing rectal bleeding and a sudden worsening of abdominal pain,' and 'Lotronex should not be used in patients who are currently constipated or whose predominant bowel symptom is constipation,' are minimized and hidden," according to the memo.
In June 2002, the FDA allowed Lotronex back on the market, under new restrictions that critics said were far too lax in protecting consumers.


The FDA buckled under industry pressure to re-approve the drug, critics said:
The agency could have classified Lotronex as an experimental drug, allowing it to be prescribed under tighter restrictions, but GlaxoSmithKline refused.

The FDA approved a program intended to educate patients about the risks of Lotronex and prevent the drug from being prescribed inappropriately.

However, the program is run by GlaxoSmithKline -- "a classic case of the fox guarding the hen house," said Larry Sasich, a pharmacist and research analyst with government watchdog group Public Citizen.



Do I have a Lotronex case?


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