After a new study linked Depakote and other valproate medications taken during pregnancy to an increased risk of autism and autism spectrum disorders, the FDA has decided to put its strongest warning for pregnancy associated complications on the drug, designating it pregnancy class X for migraine prevention, which means that the drug’s dangers … [Read more...]
FDA Struggles to Prevent Recurrence of Meningitis Outbreak
On May 9, the FDA warned that unless it gets additional authority to regulate compounding facilities, we will likely see a recurrence of the multistate meningitis outbreak that killed nearly 50 people and sickened more than 700. In the meantime, though, the FDA has followed through on its promise to inspect “high-risk” facilities, which has already … [Read more...]
FDA Warns of the Dangers of DMAA (Dimethylamylamine)
The FDA has warned consumers not to take any dietary supplement containing the ingredient DMAA (dimethylamylamine, which goes by other names as well, listed below), which has been associated with numerous risks, including seizures, heart attack, and death. When asked by the FDA to stop using the ingredient, most companies complied. USPLabs … [Read more...]
FDA Warns Durata Quality Control Problems Could Lead to Fines or Worse for St. Jude
Last week, the FDA warned manufacturer St. Jude that quality control and design problems related to the Durata ICD lead must be resolved within 15 days from the date of the letter (January 10) or the firm would face additional action, such as fines, seizures, or injunctions against selling the leads or other products. In a report to the Securities … [Read more...]
SSRI Antidepressants and Birth Defects: Lawsuits Increase but Evidence Remains Unclear
Some studies suggest that when women take SSRI antidepressants, their baby may be at an increased risk for certain types of birth defects. These birth defects are mostly heart defects that may require additional surgery and may have a lifelong impact on the child. Although more and more parents are seeking compensation for these defects, further … [Read more...]
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