FDA gives nod to label change for misoprostol
The drug label for misoprostol (Cytotec, Pharmacia Corp., Peapack, NJ) has been revised to reflect its use in labor induction, as well as its role in the Food and Drug Administration (FDA)-approved regimen for medical abortion.
The original labeling for the drug stated that pregnant women should never use it. The new labeling clarifies that the contraindication is for pregnant women who are using misoprostol to reduce the risk of nonsteroidal anti-inflammatory drug-induced stomach ulcers. The contraindication now refers to the drug’s approved indication; it does not contraindicate off-label uses.
Pharmacia received notification of the FDA approval of the new wording in April 2002, confirms Mark Wolfe, director of corporate communications. The company had worked with the federal agency for more than two years to revise the drug labeling, according to a statement issued by Pharmacia.1
"We recognize that physicians will use their own professional judgment to prescribe any pharmaceutical product outside its FDA-approved indication in the interest of their patients based on published research, expert clinical opinion, and their experience," reads the statement. "As Pharmacia has consistently stated, we intend to continue making Cytotec available to physicians and patients."
The FDA approved misoprostol in 1988 for the prevention of gastric ulcers associated with the use of NSAIDS. Since that time, however, the drug has been used on an off-label basis, particularly for cervical ripening as a prelude to induction of labor and as the second component to early medical abortions using mifepristone.
Review label changes
The new labeling includes a new labor and delivery section and provides safety information related to those uses. It also provides new information that uterine rupture, an adverse event reported with Cytotec, is associated with risk factors, such as later-trimester pregnancies, higher doses of the drug, including the manufactured 100-mcg tablets, prior cesarean delivery or uterine surgery, and having had five or more previous pregnancies.
According to the FDA, risk factors allow physicians to identify patients who may be at greater risk for these adverse events; the new information may guide safer use of the drug.
Since Pharmacia has not studied the drug for the purpose of labor induction or for the early termination of pregnancy, it contends that it "does not have the necessary relevant information to support its therapeutic use nor to provide guidance in these areas," according to its corporate statement.
The new labeling for Cytotec is an acknowledgment of the use of the drug for cervical ripening in labor induction, notes Stanley Zinberg, MD, MS, ACOG’s vice president of practice activities and deputy executive vice president.
"It is still ACOG’s opinion that based on current evidence, Cytotec is a safe and effective agent for the induction of labor when used appropriately," he states.
Although the new labeling does not approve the use of misoprostol in pregnancy, it recognizes that the drug is used for abortion and obstetrical practice and that a large body of evidence supports these uses, says Philip Darney, MD, MSc, professor at the University of California, San Francisco, and chief of the department of OB/GYN at San Francisco General Hospital Medical Center. The change ought to make clinicians, as well as their hospitals or other employers, feel more confidant about evidence-based applications of misoprostol for the care of pregnant women, Darney asserts. (The new labeling is available in Adobe Acrobat PDF format at the FDA web site www.fda.gov/medwatch; click on "Safety Information," then "2002" under "Safety Alerts for Drugs, Biologics, Devices, and Dietary Supplements." Click on "Drugs" to find the PDF document for Cytotec.)
Reference
1. Pharmacia Corp. Clarification: Cytotec Indication and Use — New FDA-Approved Label. Peapack, NJ: April 18, 2002.
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