When Adrienne Alexander, 70, of Bethesda, found out last summer that the Food and Drug Administration (FDA) was allowing Lotronex back on the market, she couldn't wait to get her hands on it. Seven months later, she's still waiting -- and looking for a doctor who will prescribe the drug for her.
Lotronex was introduced as a treatment for irritable bowel syndrome (IBS) in 2000 and recalled nine months later after it was linked to several cases of intestinal blockage and at least five deaths. It was reintroduced in November -- a first for a drug that had previously been withdrawn -- after IBS patients besieged the FDA and the drug's maker, GlaxoSmithKline, seeking access to the drug and an FDA advisory panel recommended its return, with a list of provisos.
The list is awfully long, and it includes a requirement that prescribing doctors attest to their knowledge of who should get the drug and how to spot and treat side effects; forms patients and doctors must sign indicating they understand the drug's risks and benefits; and a sticker doctors give patients once the papers are signed, without which a pharmacist will not dispense the drug.
A few other drugs, including felbamate for epilepsy and clozapine for schizophrenia, require informed-consent forms from patients and a doctor's registration with the drug's company. But those drugs are generally used to treat potentially life-threatening conditions. IBS is not, which is why some doctors and health advocates, including Public Citizen's Health Research Group, decried the return of a drug that some say is more dangerous than the disease it treats.
While patient testing show an IBS patient's bowels to be normal, the condition causes pain and bloating and either frequent diarrhea or constipation, or a combination of both. Estimates on the number of people with IBS range from 3 percent to 20 percent of the U.S. population.
And though it's not fatal, IBS sufferers say the condition can impact their lives as much as a life-threatening disease. Alexander says she was able to work only because her job is in a small retail store with its own restroom, but she limited her vacations to cruises that never left her far from a toilet. Jeffrey Roberts, co-founder of the Lotronex Action Group, which was behind the patient effort to get the drug reintroduced, says he was only able to attend hearings at the FDA last summer without continually needing to leave the room because he had hoarded a few Lotronex pills from a prescription filled before the drug's recall.
Three months after Lotronex's return, it can be difficult to find a doctor who will prescribe it. The gastroenterologist who prescribed Alexander's Lotronex before its recall has since transferred his patient load to another doctor, who refuses to prescribe the drug. So does Alexander's internist.
A brief sampling of private gastroenterologists in the Washington area found none that had completed Glaxo's paperwork to become a prescriber, two in the process and several who said they would if a patient asked. The University of Virginia Medical Center is completing paperwork to permits some of its doctors to write Lotronex prescriptions, and at least one doctor at George Washington University Hospital is now able to do so.
Some doctors will impose their own conditions: William Stern, a Rockville gastroenterologist who is in the process of filing the paperwork, says he will write Lotronex prescriptions but will require a full evaluation of a new patient before prescribing it.
Other Washington area doctors say there is nothing that could convince them to prescribe the drug. David Shocket, a gastroenterologist in private practice, says he won't prescribe the drug because it has known side effects. He says he will continue to try conventional therapies including fiber, antispasmodics and antidepressants. Shocket says the potential liability associated with prescribing Lotronex is another sticking point. At least four Washington lawyers are recruiting clients who believe they were harmed by Lotronex's side effects before it was taken off the market.
Some physicians may also be deterred by the paperwork that needs to be completed to prescribe the drug, and patients shouldn't expect that to change.
Ramona Jones, a Glaxo spokeswoman, says 3,000 doctors across the country have signed up so far, with 150 of those in Maryland, Virginia or the District. Glaxo does not give out names of doctors who prescribe the drug, and the American Gastroenterological Association lists doctors by state but not by prescribing practices.
The Treatment Group's Web site (www.geocities.com/doctorsforlotronex) lists only 11 doctors in nine states as prescribers of Lotronex, but Roberts hopes to update frequently.
One important issue doctors will investigate is the type of IBS a patient has. According to market research firm Decision Resources of Waltham, Mass., about 25 percent of IBS patients have the diarrhea-predominant form of the condition (which Lotronex is approved for treating), while 45 percent have constipation-predominant IBS (for which a new drug, Zelnorm, was approved in July) and 25 percent have alternating constipation and diarrhea. While patients with the constipation variety say they have been helped by Lotronex, experts think those are the patients most likely to suffer intestinal blockages and Glaxo's physician materials warn against prescribing the drug for this group.
In any event, patients shouldn't expect a reduction in the paperwork and restrictions for Lotronex any time soon. While Roberts originally protested the number of hoops that patients would have to go through to get the drug, he's currently a strong supporter. Roberts says "the system might actually be helping the patient get more attention from their doctor, which in the long run might create a better doctor-patient relationship." Studies suggest that IBS patients with a healthy doctor-patient relationship cope better with their symptoms, he notes.
For now, IBS patients hoping to get the drug should first read the guidelines issued by Glaxo at www.lotronex.com. If you fit the criteria for taking the drug and your own doctor won't prescribe it, check the action group's Web site mentioned above. Or try the doctor locator offered by the American Gastroenterological Association at www.gastro.org, which lists doctors by state. Roberts also suggests taking the Glaxo materials to your doctor, even if you've been turned down previously, to see if you might be a good fit.
Some doctors say they may just need to be nudged. "[I'm] not currently prescribing the drug, only because it has not come up," says Jim Smith, head of the Gastroenterology Department at Ochsner Clinic Foundation in New Orleans. But, says Smith, "I feel comfortable prescribing it for the right patient if and when they come along."•
Francesca Lunzer Kritz is a regular contributor to the Health section.