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 … Continued
Articles by Candelaria
About Candelaria
Matthew worked at Page 1 Solutions for five years, writing content to support SEO for lawyers. He has written on virtually all areas of law including personal liability, eminent domain, immigration law, and family law, but specializes in analyzing complex areas such as drug recalls and medical malpractice.
Matthew Candelaria is also a science fiction scholar with numerous published articles and a pair of anthologies on science fiction.
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Here are the author's recent posts:
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, … Continued
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, … Continued
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 … Continued
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 … Continued
Drug Companies Facing Lawsuits Over Ineffective Drugs
Pfizer’s First: Will More Drug Companies Face Lawsuits over “Ineffective” Drugs? Last week, a California woman filed a lawsuit against Pfizer, the maker of Zoloft, alleging that Zoloft works no better than placebo, that Pfizer knew it, and that the … Continued
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 … Continued
Alabama Court Rules Man Taking Generic Drug Can Sue Name Brand Manufacturer
it seemed that people injured by generic drugs that lacked adequate labeling may have no right to compensation. On Friday January 11, though, the Alabama Supreme Court proposed a logical solution to the problem: people injured by generic drugs can sue the name brand manufacturer who is responsible for the inadequate label.
FDA Warns LASIK Providers about Lack of Risk Information
On December 18, the FDA sent warning letters to five LASIK providers that they are failing to provide adequate information about risks to potential patients. This targeted follow-up comes after more than three years of communication with eye care professionals … Continued
Transvaginal Mesh Problems
Transvaginal mesh has become a symbol for all that is wrong with the current system for evaluating medical technology. The product was never thoroughly evaluated for use in pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Because of lax … Continued
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 … Continued
FDA Investigates Bed Rails to Stop the Sleep of Death
Bed rails are supposed to protect elderly and frail patients from the risk of serious injury or even death from falling out of bed. However, bed rails actually cause injury and death. Regulators know it. Bed rail manufacturers know it. … Continued
FDA Inspection of Plant in Meningitis Outbreak Reveals NECC May Have Known of Contamination
An FDA inspection of the New England Compounding Center (NECC) linked to the meningitis outbreak revealed the company may have known about contamination for months before the outbreak but did not take action. The inspection’s results revealed numerous conditions that … Continued