AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
Neonatal toxicity and withdrawal: FDA considers SSRI label change.(News)
ROCKVILLE, MD. -- A Food and Drug Administration advisory panel supported the addition of information to the professional label and patient package insert of serotonin reuptake inhibitors concerning neonatal withdrawal syndrome and toxicity reports in newborns exposed to the drugs during the third trimester.
At a meeting of the FDA's Pediatric Subcommittee Panel last month. the panel agreed that the class labeling changes for the selective serotonin reuptake inhibitors (SSRIs) and for venlafaxine, a serotonin norepinephrine reuptake inhibitor (SNRI), were reasonable. The changes, which had been proposed by the FDA, have already been added to the labels of several such agents; others have agreed to or are considering the changes.
The panel also agreed that enhancing the existing patient information leaflet--or including this information in an insert if the drug package has none--would be helpful for pregnant women taking these medications, and could help counteract the less well-balanced risk-benefit information that can be found by searching the Internet.
At the meeting--held to discuss reports of neonatal withdrawal after in utero exposure to a serotonin reuptake inhibitor (SRI), and other issues related to pediatric adverse events reports associated with certain drugs--the panelagreed that there should be further education of physicians about the information added in the label, through medical societies or some other venue.
Panel members did not support the idea of a "Dear Health Care Professional" letter, issued by pharmaceutical companies, or a public health advisory, issued by the FDA. The panel didn't make any formal votes.
A consultant to the panel, Dr. Katherine Wisner, professor of psychiatry, ob.gyn., and reproductive sciences and epidemiology at the University of Pittsburgh, said the point of adding this information is to help patients recognize that there are adverse effects that newborns may develop when these drugs are taken in the third trimester, which needs to be considered in the context of a risk-benefit decision.
The class labeling change includes the statement that neonates who have been exposed to an SRI, which includes both SSRIs and the SNRI venlafaxine, late in the third trimester have developed adverse events that have required prolonged hospitalization, respiratory support, and tube feeding. A list of symptoms includes respiratory distress, cyanosis, apnea, feeding difficulties, vomiting, hypoglycemia, tremors, jitteriness, irritability, and constant crying, which the label says are "consistent with SSRI/SNRI discontinuation symptoms or direct toxic effects of the drug," said Dr. Robert Levin, who is a reviewer in the FDA's ...
- FDA: reports of adverse events, deaths related to Cypher stent.
- Newspaper article from: Medical Device Daily October 30, 2003 700+ words
FDA: reports of adverse events, deaths related...and to report any adverse events to the agency...letter said that the FDA had received 47...notification, the FDA said that it has...the source of the adverse events and, along with...
- FDA urged to step up regulation of supplements: adverse events are largely...
- Magazine article from: Family Practice News Sullivan, Michele G. March 15, 2009 700+ words
...page report, the FDA should be tracking all levels of adverse events related to the...October 2008, the FDA received 948 reports of adverse events, compared with...recommended that the FDA require reporting of all adverse events, regardless of...
- FDA alerts consumers about adverse events associated with "permanent makeup".
- Newspaper article from: Medical Letter on the CDC & FDA August 1, 2004 700+ words
...matter. To date, FDA has been made aware of more than 50 adverse events and is investigating...market, based on six adverse events that had been reported. However, FDA has obtained additional reports of adverse events involving ink shades...
- FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular...
- Press release article from: M2 Presswire February 22, 2007 700+ words
...2007-US FDA: FDA Directs ADHD Drug...about Cardiovascular Adverse Events and Psychiatric...The guides contain FDA-approved patient...prevent serious adverse events. Patients being...self-esteem. An FDA review of reports...serious cardiovascular adverse ...
- FDA reviews oral contraceptive safety in teens: one-year study of adverse...
- Magazine article from: Internal Medicine News Mechcatie, Elizabeth October 1, 2005 700+ words
...pediatric drug development. The FDA's review of adverse events reported for Ortho Tri...2005, the year after the FDA granted marketing exclusivity...advisory panel agreed with the FDA that monitoring of adverse events for these OCs could be switched...
- FDA releases guidance for dietary supplement adverse events records.
- Magazine article from: The Food Institute Report July 20, 2009 700+ words
...mandatory reporting to FDA of serious adverse events associated with dietary...related to non-serious adverse events of which they are made aware for six years. FDA may examine all records...serious and nonserious adverse events during an inspection...
- FDA to publish final GMPs for 21st century guidance by August, adverse events...
- Newspaper article from: Validation Times Sami, Tamra March 1, 2004 700+ words
...Reducing adverse events remains one of FDA's biggest priorities...of the drugs FDA approves have...market due to adverse events. "This is extremely...to get them [adverse events] down," Crawford...available to FDA." Crawford...
- FDA acts to strengthen controls on imports of certain drugs: FDA Commissioner...
- Newspaper article from: Biomedical Market Newsletter December 31, 2002 700+ words
...M.D., has set as a major FDA priority the reduction of preventable adverse events. "The FDA is committed to taking action...these products not approved by FDA, increases the risk of serious adverse events for patients who might otherwise...
