The FDA will mandate that pharmaceutical companies conduct studies to determine if opioids are effective for long-term pain. The move comes as the federal government tries to stem the opioid epidemic, and many health experts believe long-term use can lead to addiction. A meta-analysis evaluating the effectiveness of opioids for chronic pain found that their effects tend to wane over time. FDA Commissioner Scott Gottlieb told The Washington Post that the new requirement for research would apply to immediate and extended-release opioids taken outside of a hospital or healthcare facility, and apply to products already on the market and those applying for FDA approval. Posted February 25, 2019. Via The Washington Post.
The FDA will hold its first hearings in April on how to regulate cannabidiol (CBD), a non-psychoactive compound found in marijuana, in supplements, food and drinks. Last year, Congress passed legislation that legalized CBD derived from hemp. However, FDA regulations prohibit adding CBD to food and drinks. Testifying before a House committee on Feb. 27, FDA Commissioner Scott Gottlieb said that the agency might regulate higher concentrations of CBD with stricter controls than at lower concentrations that could be considered food products and have a simpler review process. Many people use CBD products to treat conditions such as pain, insomnia, anxiety and appetite. Posted February 27, 2019. Via CNBC.
The FDA is warning of an increased risk of blood clots and deaths in rheumatoid arthritis (RA) patients who take a higher-than-approved dose of Xeljanz (tofacitinib). The agency said that results from a post-market safety trial found that RA patients taking Xeljanz 10 mg twice daily had an increased risk of blood clots in the lungs and death compared to patients taking a 5 mg twice-daily dose. Xeljanz’s prescribing information for RA says the dose should be 5 mg twice daily. The FDA says patients on Xeljanz should seek medical attention immediately if they have signs or symptoms of a blood clot: sudden shortness of breath or difficulty breathing; chest pain or back pain; coughing up blood; excessive sweating; clammy or bluish-colored skin. Posted February 25, 2019. Via FDA.