FDA Aggiornamento, Farmaci Antipsicotici in Gravidanza

FDA Updates Pregnancy Section Labeling for Antipsychotic Drugs

Washington, DC: The FDA has notified healthcare professionals that the pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
Antipsychotic drugs included in this labeling change are Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, Symbyax.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

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If your child has suffered illness, an adverse health event or birth defect resulting from the use of any of the above products, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

Last updated on Feb-22-2011

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Studio: farmaci come Abilify potrebbero non aiutare con lo stress

Study: Drugs Like Abilify May Not Help with Stress

August 27, 2011

Washington, DC
A new study suggests that drugs like Abilify may not be effective in dealing with severe stress. Furthermore because of the risk of Abilify side effects, these drugs may be more risky for patients than necessary. Concerns about Abilify side effects include problems with Abilify for children and concern about problems with Abilify and pregnancy.
The study, which was reported in The New York Times (08/02/11), suggests that drugs used to treat severe post-traumatic stress symptoms have approximately the same effectiveness as placebos but also carry serious side effects. Published in The Journal of the American Medical Association, the study examined the use of Risperdal to treat veterans with post-traumatic stress symptoms. Risperdal, an antipsychotic medication, is in the same class of drugs as Abilify and Seroquel, leading experts to conclude that the same results could be found of Abilify.

Researchers found that veterans who were given Risperdal to treat post-traumatic stress had a similar recovery rate as those who were given a placebo. After six months of treatment, approximately five percent of veterans in both groups recovered and between 10 and 20 percent had some improvement, but had not fully recovered. This led researchers to conclude that treatment with the medication did not have an overall benefit for the veterans.
In February 2011, the US Food and Drug Administration (FDA) issued a warning about the use of Abilify during pregnancy. According to the warning, use of Abilify while pregnant could cause abnormal muscle movements and withdrawal in infants exposed to the medications prior to birth. Symptoms of these conditions include agitation, abnormal muscle tone, tremors and severe difficulty breathing.
The FDA noted that a search of the Adverse Event Reporting System (AERS) through October 29, 2008, found 69 cases of neonatal events, including abnormal muscle movements or withdrawal with all antipsychotic drugs. The agency reported that it was not known if the cause of the events were drug toxicity or drug withdrawal. Onset of symptoms ranged from birth to one month after birth. According to the FDA, some infants recovered on their own, while others required intensive care and prolonged hospitalization.

Women who take Abilify and are pregnant or planning on becoming pregnant should discuss their options with their doctor.
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