Most drug clinical studies exclude lactating women, meaning the effect of a medication on a mom and her newborn are unclear. A look at 575 drug and biologics approved by the FDA found that only 15% of them included data on lactation and post-marketing studies examining the impact of the medication on lactation included only 11 products. These studies enrolled just 27 women. More than half of women worldwide take at least one medication in the months after giving birth. While there is a desire to protect women and their babies from harm, that gets translated to a reluctance to include them in research” lead author Catherine Spong, MD, a professor of obstetrics and gynecology at University of Texas Southwestern Medical Center wrote in a commentary for the New England Journal of Medicine. “By excluding them, the evidence for their care is limited. “We must recognize that inclusion is better than absence of data on treatment.” Posted April 4, 2019. Via New England Journal of Medicine.
The FDA will hold a public meeting next month to discuss ways of regulating cannabidiol (CBD) products aimed at consumers. Products made from CBD, a non-psychoactive component of marijuana, are growing and are used in food and drinks, cosmetics, creams, oils and nutritional supplements. These products are largely unregulated now. Anecdotal evidence indicates CBD can be used in the treatment of pain, insomnia and seizures, as well as other conditions. The FDA has also been cracking down on companies marketing CBD products and making unsubstantiated health claims. The public hearing is scheduled for May 31. Posted April 2, 2019. Via FDA.
The FDA has issued warning letters to several companies that make homeopathic products for violating good manufacturing practices. During inspections of a facility run by King Bio. Inc., FDA inspectors found high microbiological contamination. Since 2018, the FDA has recalled more than 900 products from the company. The FDA cited Red Mountain Inc. for manufacturing homeopathic products that contain potentially toxic ingredients, including snake venom. And B. Jain pharmaceuticals, based in India, was issued a warning letter for insects observed in the manufacturing facility and in ingredients used to make its products. Posted April 1, 2019. Via FDA.