Monday, June 20, 2011

Topamax and cleft Palate

http://pmep.cce.cornell.edu/profiles/insect-mite/abamectin-bufencarb/avermectin/insect-prof-avermectin.html
Excerpt:
The results of a series of
developmental toxicity studies (rat, rabbit, mouse) have been evaluated
and showed that avermectin B1 produces developmental toxicity (cleft
palate) in the CF1 mouse.  Toxicology data were also evaluated for the
delta-8,9-isomer of avermectin B1 which is a plant photodegradate that
can range between 5 and 20 percent of the residue on/in cottonseed. 
This isomer possesses avermectin-like toxicological activity.  It was
concluded that the delta 8,9-isomer also produces developmental toxicity
(cleft palate) in mice, but not in rats.

http://www.ncbi.nlm.nih.gov/pubmed/17608552
Except:
CONCLUSIONS:
The results of this meta-analysis suggest that maternal exposure to pesticides is associated with a modest but marginally significant risk of clefting. To better understand the relationship between pesticide exposure and orofacial clefts, future studies should consider evaluation of multiple routes of parental exposure, etiologically homogenous phenotypes, and individual genetic susceptibility.

http://www.kidsforsavingearth.org/mnchec/articles/pesticides.htm
Excerpt:
A study of pregnant women in Iowa and Michigan found that women exposed to multiple pesticides had an increased risk of giving birth to a child with cleft palate. (Gordon, 1981)


http://www.aboutlawsuits.com/topamax-birth-defect-warning-16670/
Excerpt:
The FDA Topamax birth defect drug safety communication, issued on Friday, warned that there was a particular risk of cleft lip and cleft palate birth defects associated with the drug.

http://www.kerrysteigerwalt.com/topamax/topamax_lawsuit.html?gclid=CJXh1qeNxKkCFSk6gwodlh4cZw
Excerpt:

Have you or a loved one used Topamax® ?

Use of the drug during pregnancy has been linked to cleft lip and cleft palate defects in children.

Friday March 4 The FDA announced that new data shows expecting mothers taking the drug Topamax (generic Topiramate) are almost 20 times more likely to have children born with cleft lips or cleft palate deformities than those not used the drugs. The drugs are used to treat epilepsy and migraine headaches.



http://schema-root.org/commerce/corporations/consumer/johnson_&_johnson/
Excerpt:
Johnson & Johnson has not announced any plans to recall Topamax in the wake of the FDA's birth defect warning. However, the patient medication guide and warning label for Topamax and generic topiramate will be updated in accordance with the FDA's ...

Boston’s Kelley Law Group, P.C. Takes on Johnson & Johnson over Failure to Warn Mothers of Topamax® Birth Defect Risks

WEBWIRE – Monday, June 13, 2011
Contact Information
Steven Swartz
Dir. Public Relations
Kelley Law, P.C.
888-761-4970
stevenswartzpr@gmail.com
BOSTON, MA – June 13, 2011 -- Kelley Law Group, P.C.-- http://www.duejustice.com/ -- has announced they will be filing product liability lawsuits against Ortho-McNeil Neurologics and Noramco, Inc., both subsidiaries of Johnson & Johnson, for their failure to adequately warn women of birth defect risks associated with their blockbuster drug Topamax.

Topomax (topiramate) was approved by the Food and Drug Administration (FDA) to treat epileptic seizures and prevent migraines. It is also prescribed by doctors for off-label treatment of other conditions like bipolar disorder, obesity, hypertension and alcoholism.
On March 4, 2011, the FDA issued a safety alert to medical providers and patients warning that Topamax and generic topiramate increase the risk for oral cleft birth defects like cleft lip and cleft palate, in children born to mothers who took the drug while they were pregnant.

http://topics.nytimes.com/topics/news/health/diseasesconditionsandhealthtopics/topamax_drug/index.html
Excerpt:
Topamax (Drug)
A free collection of articles about Topamax (Drug) published in The New York Times.

ARTICLES ABOUT TOPAMAX (DRUG)

Newest First | Oldest First
Page: 1 | 2 | Next >>
Women Warned About Epilepsy Drug
The Food and Drug Administration warned women of child-bearing age that the epilepsy drug Topamax can increase the risk of birth defects around the mouth.
March 5, 2011
    Drug Makers To Pay Fine Of $81 Million
    Johnson & Johnson subsidiaries agree to pay more than $81 million fine to settle case accusing them of illegally promoting epilepsy drug Topamax for psychiatric uses
    April 30, 2010
      Johnson & Johnson Plans to Cut 4,800 Jobs
      The cuts, along with other streamlining efforts, would save the company $1.3 billion to $1.6 billion a year.
      August 1, 2007
        Drug Maker Subpoenaed About Marketing
        Johnson & Johnson received subpoenas from federal prosecutors related to sales and marketing of three drugs.
        March 13, 2007
          COMPANY NEWS; JOHNSON & JOHNSON HALTS EFFORT ON NEW USES OF DRUG
          Johnson & Johnson abandons efforts to develop its Topamax epilepsy medicine as treatment for obesity and diabetes after studies show it is not effective
          December 2, 2004
            COMPANY NEWS; U.S. FAULTS JOHNSON & JOHNSON PROMOTION OF DRUG
            Food and Drug Administration says certain promotional materials for Johnson & Johnson's epilepsy drug Topamax fail to disclose serious risks linked to medicine and asks company to stop using them
            September 24, 2004
              COMPANY NEWS; F.D.A. ALLOWS EPILEPSY DRUG TO BE SOLD FOR MIGRAINES
              Johnson & Johnson receives Food and Drug Administration approval to market its Topamax epilepsy pills for preventing migraine headaches
              August 13, 2004
                Spitzer Asks Drug Maker For Off-Label Use Material
                Johnson & Johnson says New York State Atty Gen Eliot Spitzer has asked for information about six of its drugs, including marketing materials, results of clinical trials and data on prescription for so-called off-label use; drugs at issue are antiseizure drug Topamax, antipsychotic drug Risperdal, anemia medication Procit, Alzheimer's drug Reminyl, rhematoid arthritis medication Remicade and Aciphex, drug to relieve acid reflux; GlaxosmithKline and Forest Laboratories have come under scrutiny by...
                August 4, 2004
                  U.S. Subpoenas 2 Drug Makers
                  United States attorney's office in Boston subpoenas documents from Johnson & Johnson on sales and marketing of its Topamax epilepsy drug; company says it cooperates; Health and Human Services Department fraud monitors ask Watson Pharmaceuticals Inc for data on 'feedback meetings' company had with doctors about its Ferrlecit anemia drug; Watson says it cooperates
                  December 13, 2003
                    COMPANY NEWS; JOHNSON DRUG CLOSER TO APPROVAL FOR MIGRAINE USE
                    Johnson & Johnson moves close to selling seizure drug Topamax to treat migraines after Food and Drug Administration says it is prepared to clear new use
                    November 19, 2003

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