AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.

Letters.(Opinion)(Letter to the Editor)

OB GYN News

| February 01, 2006 | COPYRIGHT 2006 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Details on Adverse Events

It would be very useful to get a bit more detail on the adverse events connected to the maternal use of citalopram during pregnancy reported to the Food and Drug Administration since 1998 ("Maternal Citalopram Tx Spurs Adverse Events," Sept. 15, 2005, p. 1).

Among the questions I would like to see answered:

1. What exactly is an "adverse developmental event?"

2. Does this include data on mothers? How many reports were maternal experiences?

3. SSRI withdrawal syndromes are usually benign and time limited by definition. An exception to the benign rule would be seizure. Were any seizures reported during withdrawal? Were those seizures reported in babies or in mothers?

4. Were there any physical anomalies in newborns? Those are the worst-case scenarios when I think about maternal use of medicine during pregnancy.

Related articles from newspapers, magazines, journals, and more
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...
For more facts and information, see all results
©2009 Gale, a part of Cengage Learning. All rights reserved.
About us | FAQs | Contact us | Privacy policy | Terms and conditions
Other Gale sites: Encyclopedia.com | HighBeam Research | Acquire Content | Books & Authors | Goliath | MovieRetriever | Smart QandA