FDA panel considers patients' pleas to bring back risky bowel drug
Tuesday, April 23rd 2002, 12:00 am
By: News On 6
BETHESDA, Md. (AP) _ When he heard Lotronex was being pulled off the market, Atlanta architect Corey Miller raced from pharmacy to pharmacy to stockpile the drug, his only relief from devastating irritable bowel syndrome.
The once-popular bowel drug is blamed for severe side effects that hospitalized more than 150 people, forced some patients to have parts of their intestines surgically removed, and even killed several.
But Miller calls it his miracle _ until his hoarded stash ran out a few months ago. So Tuesday, he was joining other desperate patients to beg the Food and Drug Administration to let Lotronex sell again despite its risks.
However, to win FDA approval to resume sales, Lotronex's maker is pledging major restrictions to make sure patients like Miller can't buy it.
The pills are intended only for seriously ill women _ not men _ who have a certain type of irritable bowel syndrome and have exhausted other therapy, a population manufacturer GlaxoSmithKline says will benefit enough from Lotronex to chance the risks.
Under Glaxo's plan, only certain physicians experienced in treating the irritable bowel syndrome could prescribe Lotronex; women would have to sign a form swearing they understand the risks; and pharmacists could fill only prescriptions bearing a special sticker showing that happened. Patients initially could get only a 30-day supply, and would be told to try 1 milligram a day, half the originally recommended dose.
To see if the restrictions work, Glaxo would survey patients who buy it at Eckerd drugstores and monitor medical records of Lotronex users insured by United Healthcare.
But critics say the plan isn't tough enough to save lives, much less deter determined patients for whom it's not considered safe.
The FDA was seeking advice from independent scientists Tuesday, hoping to strike a balance between patients' desperation for treatment and their safety.
``There may be a way,'' said FDA's gastrointestinal drugs chief, Dr. Victor Raczkowski. ``These viewpoints may not be mutually exclusive.''
The FDA approved Lotronex in February 2000 as the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 11 percent of Americans, mostly women. Irritable bowel syndrome is not life threatening but can cause misery. It involves chronic or recurrent abdominal pain, the sudden and urgent need to go to the bathroom and either frequent diarrhea, constipation or both.
In studies, Lotronex offered modest relief to women whose main symptom of the syndrome was diarrhea. It wasn't proved to work for men, and was declared dangerous for anyone with constipation.
But nine months later, Glaxo pulled Lotronex off the market, citing a life-threatening intestinal inflammation called ischemic colitis and constipation so severe it could require surgery.
The FDA has counted 227 reports of ischemic colitis and severe constipation among Lotronex users. Some 153 were hospitalized, 41 required surgery. Of 13 reported deaths, four were probably caused by the drug, FDA says.
How big is the risk? One in 700 patients will get a serious side effect, said GlaxoSmithKline chief medical officer Dr. Peter Traber.
The FDA allows other drugs with big dangers to sell under special programs that restrict use to the people who need the medications most but are least likely to suffer the side effect. The acne drug Accutane and leprosy drug thalidomide, for instance, cause severe birth defects, so prescriptions are limited to certain physicians who promise to ensure female patients aren't pregnant and use birth control.
Aside from patients who already have constipation, it's impossible to predict who will be most at risk from Lotronex, Traber acknowledged.
But he said restricting prescriptions and educating patients to stop the drug if they have any symptoms _ constipation, blood in the stool, unusual abdominal pain _ should help.
It's too hard to distinguish irritable bowel syndrome symptoms from Lotronex symptoms, countered Dr. Sidney Wolfe of the consumer advocacy group Public Citizen. He says Lotronex sales should be restricted to patients enrolled in special scientific studies, which Glaxo opposes.
Under Glaxo's current plan, ``it's going to cause further cases of ischemic colitis and death,'' Wolfe predicted. ``There is no way this drug will survive.''