Re: Anitpsychotic EPA effects & or withdrawal in newborns

[Guest guest]

So the FDA says they know it destroys babies, but keep on taking it pregnant

mothers.

>

> Summary

>

> A recent Europe-wide review has concluded that there is a risk of

> extrapyramidal effects or withdrawal symptoms (or both) in newborns

> after maternal use of antipsychotics during the third trimester of

> pregnancy. This conclusion is based on worldwide post-marketing case

> reports and information provided by the US Food and Drugs Administration

>

>

> There are insufficient data to determine the size of the risk or any

> difference in risk between classes of antipsychotics or between

> individual antipsychotics.

>

> UK product information for all antipsychotics will be updated to include

> consistent information about this risk.

>

> Advice for healthcare professionals:

>

> * Following maternal use of antipsychotics in the third trimester,

> examine newborns for symptoms which may include: agitation; hypertonia;

> hypotonia; tremor; somnolence; feeding problems; and respiratory

> distress * Symptoms may vary in severity and duration, and they

> should be monitored and treated (if necessary) on an individual basis

> * Expectant mothers should be counselled about the benefits and risks of

> antipsychotic treatment during pregnancy

>

> Please report suspected adverse events related to the use of

> antipsychotics during pregnancy through the Yellow Card Scheme at

> www.yellowcard.gov.uk <http://www.yellowcard.gov.uk/>

>

>

>

> Further information:

>

> Report from the European Pharmacovigilance Working Party

> <http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC5\

> 00109581.pdf>

>

> US Food and Drug Administration safety information on antipsychotic

> drugs and treatment during pregnancy

> <http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHum\

> anMedicalProducts/ucm244175.htm>

>

> Summaries of Product Characteristics <http://www.emc.medicines.org.uk/>

>

> BNF section 4.2.1 Antipsychotic drugs

> <http://bnf.org/bnf/bnf/61/3209.htm?q=antipsychotics & t=search & ss=text & p=\

> 3>

>

>

>

> Article citation: Drug Safety Update Sept 2011, vol 5 issue 2: A2.

>

>

>

>

>

> http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON128953

> <http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON128953>

>