Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

ACE INHIBITOR LABELING WILL CARRY BOXED PREGNANCY WARNING as part of class-wide labeling changes outlined in a March 13 "Dear Health Care Professionals" letter from the six manufacturers of angiotensin-converting enzyme inhibitors to over 700,000 health care providers. FDA stated in a March 13 release that Bristol- Myers Squibb, Merck, Sharp & Dohme, Warner-Lambert, Ciba-Geigy, Hoechst-Roussel, and ICI are sending out the letter simultaneously "at the agency's request." Under the revisions, a boxed warning entitled "Use in Pregnancy" will be placed at the beginning of the labeling. The warning states: "When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, [trade name of the ACE] should be discontinued as soon as possible. See warnings: fetal/neonatal morbidity and mortality." The labeling sections entitled "Pregnancy," "Fetal/Neonatal Morbidity and Mortality" and "Information for Patients" will also contain more detail on the effects of the drugs in later-term pregnancies. The labeling changes will add to existing warnings in ACE labeling against the use of the drugs by women in the second and third trimesters of pregnancy. These warnings were first put into place in 1989, FDA said. FDA cited the fact that "more than 50 cases of fetal harm have been reported in the past several years" as the reason for the labeling change. In a separate statement, Merck said that "the warning is based on case reports conveyed directly to FDA and by industry." Merck said that notification of the labeling changes is being sent out in two forms. Approximately 201,000 obstetricians, endocrinologists, primary care physicians, cardiologists and nephrologists received the letter March 13 in the form of a mailgram. Another 500,000 professionals, including other physicians, pharmacists, nurses and physician's assistants, will receive the notice through the mail. Merck estimated that there are approximately six mil. Americans taking ACE inhibitors, of whom "an estimated 5% are women under 40." The changed labeling will state that "rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found." Even if an alternative cannot be found, the drug should be discontinued "unless it is considered life-saving for the mother."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts