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

UsernamePublicRestriction
UsernamePublicRestriction

FDA's TEMPLE ON COMPARISON OF LABETALOL LABELING WITH OTHER BETA-BLOCKERS

Executive Summary

The following is a facsimile of a letter from FDA Office of Drug Research and Review Director Robert Temple, MD, concerning beta-blocker labeling. The letter comments on points contained in a story on FDA's approval of Glaxo/Schering's alpha/beta blocker labetalol ("The Pink Sheet" Aug. 13, p. 4). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service, National Institutes of Health, Bethesda, Maryland 20205 In your article on labetalol (August 13, 1984) you note that the drug's warnings for exacerbation of ischemic heart disease following withdrawal and against use in patients with bronchospastic disease are less strongly stated than in standard beta-blocker labeling. That was not intended and I do not believe it is so. Beta-blockers approved only for hypertension (labetalol, pindolol, atenolol, and metoprolol, until recently) do not carry a boxed warning about risks of sudden withdrawal because the withdrawal syndrome has been seen in dangerous form only in patients with angina. The beta-blockers with an angina claim (or a post-infarction claim) carry the boxed version (propranolol, nadolol, timolol) because they are specifically intended for use in coronary artery disease patients. This particular distinction may well be out-moded, if beta-blockers are in practice used interchangeably, but it is the basis for the current differences in labeling, not any perceived differences among the drugs. Labetalol bears the usual beta-blocker contraindication to use in asthmatics; only metoprolol and atenolol, the cardioselective agents, lack this. But the beta-blockers are not contraindicated for use in all patients with bronchospasm and contain only a warning regarding use in "non-allergic bronchospasm"; it may be that a better term here would be chronic obstructive pulmonary disease. In any case, labetalol's labeling is similar to that of other non-selective beta-blockers.

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

UsernamePublicRestriction

Register

OM004078

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

Cancel