Daily marijuana users are more than three times as likely to develop psychosis compared with those who never use cannabis. An analysis compared 900 people with a first episode of psychosis with 1,200 people who never experienced psychosis. The case-control study indicated that using high-potency cannabis boosted the psychosis risk to five times as likely. In an accompanying editorial, a researcher not involved in the study indicated that the relationship between psychosis and cannabis may be bidirectional – that is, those who have psychosis may be more likely to use cannabis. Posted March 19, 2019. Via Lancet Psychiatry.
The FDA has issued a warning letter to a company that sells homeopathic products claiming to treat chronic pain and addiction that contains snake venom. The agency says that Nutra Pharma Corp. is illegally marketing unapproved products and making “bogus claims.” Nutra Pharma sells products online under the Nyloxin brand. The company’s site claims that Nyloxin can treat conditions that cause chronic pain and snake venom can potentially be used to treat cancer and addiction. The FDA also faults Nutra Pharma for repeatedly using the term “FDA registered” next to the company logo throughout its website. Although Nyloxin is being sold as a homeopathic drug, the FDA says that those drugs are considered news drugs and subject to FDA regulation. Posted March 19, 2019. Via FDA.
The FDA has issued a warning letter to two manufacturers of breast implants for failing to conduct post-approval studies on the risks and safety of their silicone-gel filled implants. Mentor Worldwide LLC and Sientra LLC, like other silicon-gel implants makers, are required to conduct long-term safety studies. The FDA says that Mentor failed to enroll the minimum number of patients in its studies and had poor follow-up rates with patients, as well as data inconsistencies. The FDA says Sientra had a follow-up rate of only 61% and has failed to improve this low rate. If the two companies don’t come up with plans to address the FDA’s concerns, the agency could pursue criminal and civil penalties. Posted March 19, 2019. Via FDA.