FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients.
The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and marketed, may pose safety concerns.
The researchers found that the 6-week mean BPI worst pain scores were 0.92 points lower in the true acupuncture versus sham acupuncture arm, and 0.96 points lower in the true acupuncture versus waitlist control arm.
Kratom is plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. It has gained popularity in the U.S., with some marketers touting it as a "safe" treatment with broad healing properties.
The case involved a 30-year-old female with a history of anxiety and migraine who presented with complaints of malaise, right upper quadrant pain, worsening jaundice, dark colored urine, and itching; these symptoms had been going on for a few weeks.
The patient admitted to taking 2 teaspoons of self-prepared apricot kernel extract along with 3 tablets of Novodalin, an herbal fruit kernel supplement, every day for the past 5 years.
"Pediatricians should seek continued and updated knowledge about therapeutic options available to their patients (whether they are mainstream or complementary) and about the specific services used by individual patients to promote discussion about the safety, appropriateness, and advisability of complementary therapies," write the authors.
The risk of lead poisoning was initially communicated by the North Carolina Division of Public Health who tested the product and found high levels of lead.
In March and May 2017, two patients given intravenous (IV) infusions of curcumin emulsion compounded with polyethylene glycol (PEG) 40 castor oil reported having immediate hypersensitivity reactions.
The use of complementary and alternative medicine (CAM) specifically for the treatment of migraine and headache is "relatively low" in the U.S.
"The use of acupuncture with or without clomiphene, compared with control acupuncture and placebo, did not increase live births," the authors write.
The study - billed as the world's largest randomized, controlled trial of acupuncture in the emergency department - included 528 patients.
For patients who can't tolerate or afford hypertension medications, the research suggested some herbal alternatives: tiankuijiangya, zhongfujiangya, jiangyabao, and jiangya.
Researchers provided 30 patients who'd had spinal fusion surgery with a 30-minute music therapy session within 72 hours of their operation, while another group received only standard care after their procedure.
Holy basil is not recommended for pregnant or nursing mothers or young children. It should also be used with caution in patients with diabetes.
Findings from a systematic review showed low- to moderate-certainty evidence that yoga vs. non-exercise controls resulted in small to moderate improvements in back-related function at Months 3 and 6.
Raritan Pharmaceuticals announced a voluntary recall of several homeopathic products due to the potential for variation in the content of belladonna extract.
After the FDA's safety alert regarding homeopathic teething tablets in 2010, the Agency has been evaluating reported adverse events related to use of these products such as seizures.