Fwd: Antidepressants Linked to Withdrawals in Newborns

[Guest guest]

Interesting article on newborns suffering withdrawal from psychiatric

drugs their mothers took.

 

Kind regards

Sepp

 

 

http://www.bloomberg.com/apps/news?pid=10000103 & sid=aaWQez5K8H1g & refer=us

 

Antidepressants Linked to Withdrawals in Newborns, Study Says

 

 

Feb. 4 (Bloomberg) -- GlaxoSmithKline Plc's Paxil, Eli Lilly & Co.'s

Prozac and other antidepressants may cause convulsions and other

withdrawal symptoms in newborns whose mothers took the drugs during

pregnancy, according to a study in the Lancet medical journal.

 

Paxil, also known as paroxetine, was associated with two- thirds of

the infant withdrawals from antidepressants known as selective

serotonin reuptake inhibitors, or SSRIs, in the study by researchers

from the University of La Laguna, Spain. Drawing from reports on

adverse drug reactions from a database operated by the World Health

Organization, the study identified 93 cases of withdrawals in babies

born to mothers who took the drugs.

 

``Paroxetine emerged as the most likely offending party,'' said

Vladislav Ruchkin and Andres Martin of the Child Study Center at Yale

University, in a commentary accompanying the study. ``And while there

may be plausible explanations for such a distinction, it would be

unwise to assume the other SSRIs are immune to the problem.''

 

SSRIs are among the most commonly prescribed drugs in the U.S. with

about $11 billion in U.S. sales, according to IMS Health Inc. They

have come under increased scrutiny by health regulators because of

reports of child suicide risk and other potential side effects. The

European Medicines Agency recommended last year SSRIs not be given to

children, and the U.S. Food and Drug Administration ordered that

antidepressants carry the strictest warning on child-suicide risk.

 

In December, EU health authorities also recommended Glaxo strengthen

warnings about severe withdrawal symptoms in adults when they stop

taking Paxil.

 

Paxil Label

 

The U.S. Paxil label cautions that children exposed to the drug in

the womb have developed complications requiring prolonged

hospitalization, respiratory support, and tube feeding. Still, the

label tells doctors to weigh the potential benefits of the drug

against its risk in deciding to prescribe the medicine for pregnant

women.

 

``No causal link between the medication and the symptoms has been

established,'' Glaxo spokesman Chris Hunter-Ward said.

 

In the study, Paxil was linked to 64 cases of infant withdrawal,

followed by Prozac with 14 cases, Pfizer Inc.'s Zoloft with 9 and H.

Lundbeck A/S and Forest Laboratories Inc.'s Celexa with 7. One of the

patients was taking Paxil and Prozac at the same time.

 

``This is ringing the bell of caution, saying please be careful,''

said Emilio Sanz, professor of pharmacology at the University of La

Laguna and the study's lead author, in an interview. ``Careful

doesn't mean don't treat the patient, but don't use paroxetine.''

 

`Signal' Raised

 

Reports of infant withdrawal syndrome first surfaced in 1999, when

12 cases associated with Paxil were reported to the WHO database,

raising a ``signal'' to the organization's drug- monitoring

reviewers, the study said. More than one report on an adverse drug

reaction is required before a signal is generated, as well as the

seriousness of the event and quality of the information.

 

At the time, WHO authorities published the signal in the agency's

internal bulletin, which is sent to medical agencies around the

world. The information, however, was not made available to the public.

 

Doctors wrote more than 10 million prescriptions for antidepressants

last year, according to IMS Health. Sanz said he and other

researchers have no idea how many pregnant women are prescribed

antidepressants.

 

Newborn withdrawal symptoms associated with the antidepressants also

included irritability, abnormal crying and tremor, the study said.

The symptoms usually disappear after a day, Sanz said. The study,

however, raises concerns about the long- term effects of infants

exposed to antidepressants in the womb, the researchers said.

 

``Such studies indicate that we need a better understanding of SSRI

effects on the growing brain and call for a developmental perspective

on the use of psychotropic drugs in younger patients,'' Ruchkin and

Martin said in the Lancet commentary.

 

 

 

 

To contact the reporter on this story:

Angela Zimm in London at

at azimm

 

To contact the editor of this story:

Mark Rohner at

4106 or mrohner

 

 

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