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...]
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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...]
Supreme Court Should Allow Generic Drug Defective Product Claims
This month, the US Supreme Court will hear arguments in the case of a woman who suffered the gruesome skin reaction toxic epidermal necrosis (TEN) after taking a generic form of sulindac, a mild non-steroidal anti-inflammatory drug (NSAID). The case, Bartlett v. Mutual Pharmaceutical Company, Inc, follows up on 2010’s Pliva v. Mensing decision, … [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...]
Danny’s Law Continues to Make Children’s Products Safer
When Danny’s Law was introduced in March 2007, it had all the makings of a universally hailed piece of legislation. First, it stemmed from the tragic story of a child needlessly killed due to the ineffectual workings of the system designed to protect him. Second, it made modest recommendations about how the system might be improved to save lives … [Read more...]
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