Enlarge (credit: Diamond Shruumz)

The number of poisonings connected to Diamond Shruumz-brand microdosing candies has reached 145 cases across 29 states. Since the illnesses first came to light in early June, 59 of those sickened have required hospitalization, and health officials have reported people having seizures, needing intubation, and being admitted to intensive care units. Two deaths are under investigation. Yet, despite tireless efforts to analyze the candies' components, the cause of the poisonings remains a mystery.

Diamond Shruumz suggestively markets the chocolates—as well as its gummies and candy cones—as containing psychedelic drugs but doesn't say what's in them exactly. They're only said to contain a "primo proprietary blend of nootropic and functional mushrooms," and the company has identified non-hallucinogenic mushrooms, including Lion's mane, Reishi, and Chaga.

In its latest investigation update Monday, the Food and Drug Administration laid out the testing results of 22 chocolate bars from Diamond Shruumz—and the list of illicit and troubling drugs found keeps growing. Stunningly, none of the drugs found so far can alone explain the severe illnesses.

Enlarge / MDMA (credit: Getty | PYMCA/Avalon)

A scientific journal has retracted three studies underpinning the clinical development of MDMA—aka ecstasy—as a psychedelic treatment for post-traumatic stress disorder. The move came just a day after news broke that the Food and Drug Administration rejected the treatment, despite positive results reported from two Phase III clinical trials.

On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a rejection letter from the FDA. Lykos said the letter echoed the numerous concerns raised previously by the agency and its expert advisory committee, which, in June, voted overwhelmingly against approving the therapy. The FDA and its advisers identified flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials, including an alleged cult-like support of psychedelics. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).

FDA advisers also noted the public allegations of a sexual assault of a trial participant during a Phase II trial by an unlicensed therapist providing the MDMA-assisted psychotherapy.

Enlarge (credit: Diamond Shruumz)

Authorities have identified a second death that may have been caused by Diamond Shruumz microdosing candies, which are under investigation for causing a nationwide rash of severe illnesses involving seizures, and the need for intubation and intensive care.

In an update on Tuesday, the Food and Drug Administration reported that the total number of illnesses linked to the brand's candies has risen to 74 across 28 states. Of the 74 people sickened, 62 sought medical care, and 38 were admitted to a hospital. There are two potentially associated deaths that are now under investigation. The counts are up from 69 cases and 36 hospitalizations, with one potentially linked death reported in an update last week.

The FDA announced its investigation into Diamond Shruumz products on June 7, when there had been just eight cases reported from four states. The federal investigation—led by the FDA and the Centers for Disease Control and Prevention, with help from America’s Poison Centers and state and local partners—followed warnings from Arizona poison control officials.

Enlarge / A Diamond Shruumz chocolate bar, which comes in a variety of flavors. (credit: diamondshruumz.com)

The US Food and Drug Administration has identified a synthetic psychedelic compound as well as compounds from a potentially toxic plant in the Diamond Shruumz-brand microdosing candies linked to a growing number of severe illnesses nationwide that have included seizures, intubation, and admissions to intensive care units.

As of June 25, the case total has grown to 39, including 23 hospitalizations, across 20 states, the FDA and the Centers for Disease Control and Prevention reported.

It remains unclear what is in the candies and what may be causing the severe illnesses. Diamond Shruumz does not provide a full list of ingredients. The term "microdosing" and other marketing used by Diamond Shruumz suggests the candies contain a psychedelic compound, but the company does not name any. To figure it out, the FDA has been analyzing multiple samples of Diamond Shruumz-brand candies, including chocolates, gummies, and candy cones. On Tuesday, the FDA reported finding the synthetic psychedelic compound 4-AcO-DMT in the company's Dark Chocolate Bar and its Birthday Cake Chocolate Bar.

Enlarge (credit: Getty | RJ Sangosti)

After an MDMA therapy for post-traumatic stress disorder dramatically failed to impress Food and Drug Administration advisers earlier this month, researchers are moving forward with another psychedelic—a slow-release oral dose of the hallucinogenic drug ketamine—as a therapy for treatment-resistant depression.

In a mid-stage, randomized, placebo-controlled clinical trial, researchers tested slow-release ketamine pills, taken twice weekly. The trial, sponsored by New Zealand-based Douglas Pharmaceuticals, found ketamine to be safe compared with placebo. At the trial's highest dose, the treatment showed some efficacy against depression in patients who had previously tried an average of nearly five antidepressants without success, according to the results published Monday in Nature Medicine.

But the Phase II trial, which started with 231 participants, indicated that the pool of patients who may benefit from the treatment could be quite limited. The researchers behind the trial chose an unusual "enrichment" design to test the depression treatment. This was intended to thwart the high failure rates generally seen in trials for depression treatments, even in patients without treatment-resistant cases. But even after selecting patients who initially responded to ketamine, 59.5 percent of the enriched participants still dropped out of the trial before its completion, largely due to a lack of efficacy.

Enlarge (credit: Diamond Shruumz)

Cases of illnesses linked to microdosing candies have more than doubled, with reports of seizures and the need for intubation, mechanical ventilation, and intensive care stays. But, there remains no recall of the products—microdosing chocolates, gummies, and candy cones by Diamond Shruumz—linked to the severe and life-threatening illnesses. In the latest update from the Food and Drug Administration late Tuesday, the agency said that it "has been in contact with the firm about a possible voluntary recall, but these discussions are still ongoing."

In the update, the FDA reported 26 cases across 16 states, up from 12 cases in eight states last week. Of the 26 reported cases, 25 sought medical care and 16 were hospitalized. No deaths have been reported.

Last week, the Centers for Disease Control and Prevention released a health alert about the candies. The agency noted that as of June 11, the people sickened after eating Diamond Shruumz candies presented to health care providers with a host of severe symptoms. Those include: central nervous system depression with sedation, seizures, muscle rigidity, clonus (abnormal reflex responses), tremor, abnormal heart rate (bradycardia or tachycardia), abnormal blood pressure (hypotension or hypertension), gastrointestinal effects (nausea, vomiting, or abdominal pain), skin flushing, diaphoresis (excessive sweating), and metabolic acidosis with increased anion gap (an acid-based disorder linked to poisonings).