Janssen Pharmaceutica, a subsidiary of
Johnson & Johnson, yesterday announced it is drastically restricting access
to Propulsid, a nighttime heartburn drug that can cause serious heart
problems when used in conjunction with other drugs or in patients with heart
problems.
The company has issued several warnings about the drug since it was
released in 1993. In January, Janssen issued a list of drugs that patients
should not take while using Propulsid, and asked doctors to submit patients
to an electrocardiogram before prescribing the drug.
Propulsid is used to treat adults with nighttime heartburn or
gastroesophageal reflux disease, or GERD.
A recent analysis of 270 adverse events, including 70 deaths, showed
that 85 percent occurred in patients who were either taking medications that
are known to react poorly with Propulsid or had known heart problems. J&J
decided to limit access to Propulsid after discussions with the Food and Drug
Administration.
The drug will no longer be marketed in the United States, and will be
available to patients for whom other therapies are not effective and who
clearly meet eligibility requirements.
"We had several discussions with the FDA and had several label changes,"
said Bill Weldon, head of worldwide pharmaceuticals for Johnson & Johnson.
"Even so, some inappropriate uses continued in the United States. We have
worked hard to limit inappropriate use. but the vast majority of side effects
have been in the clear use of contraindicated medicines."
Patients taking medications for allergies, angina, irregular heart
rhythms, infections, depression, fungal infections, nausea, psychotic
episodes and protease inhibitors were discouraged from taking Propulsid.
But Weldon said many U.S. patients see multiple doctors and fill
prescriptions at various pharmacies, making it harder for doctors to control
use of the treatment.
The drug will continue to be marketed and sold worldwide. Weldon said
the company has fewer reports of serious side effects outside the United
States. Doctors outside this country prescribe lower doses of the drugs,
Weldon said, and tend to give it to patients who need it the most.
Bob Daretta, Johnson & Johnson's chief financial officer, said Propulsid
had sales of $150 million in the first quarter of this year, one-third of
which were domestic. Daretta estimated that the company will probably make an
additional $100 million in sales of the drug worldwide this year, but noted
that that is a "very conservative" estimate.
The removal of Propulsid shouldn't cost shareholders much in earnings
this year, he said. Estimates have put earnings at $3.35 to $3.40 a share,
and Daretta predicted earnings will be at the lower end of that estimate.
Details of how the limited-access program will work, including
eligibility criteria and the application process, are currently being
developed by Janssen, which is based in Titusville.
J&J said it will keep distributing Propulsid until July and the drug
will remain available in pharmacies through mid-August, and advised patients
taking the drug to talk with their doctors.
The move comes just two days after Warner-Lambert Co., under pressure
from the FDA, pulled its Rezulin diabetes drug from store shelves because of
its link to cases of fatal liver damage.
Shares in Johnson & Johnson fell $2.25 to close at $80. The company
released the news after the close of U.S. trading.
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