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
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
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
Lotronex sales literature contained several misleading and unsupported
according to an April 2000 warning from the FDA to GlaxoSmithKline (then
In one instance, "the implication that Lotronex would improve the
quality of life of IBS patients is unsubstantiated,"
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
The agency could have classified Lotronex as an experimental drug,
allowing it to be prescribed under tighter restrictions, but
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.
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