'Bath Salts' Manufacturers Staying One Step Ahead of Regulators

Nancy A. Melville

June 25, 2013

Increased public awareness of the dangers of synthetic stimulants, frequently dubbed "bath salts," appears to have slowed their use, but manufacturers of these "designer drugs" are managing to stay one step ahead of regulators with a new generation of products that feature clever new names and tweaked chemical formulations that are every bit as dangerous as their original counterparts.

According to a new review of the products published in the June issue of the Journal of Addiction Medicine, the new formulations mean the products are just as easy to buy as ever, and perhaps even more deceptive.

"Products sold as 'bath salts' are largely coming off the market now in response to various regulatory efforts, so if you go into a novelty shop, what you see are products sold as glass cleaner, plant food, or stain remover, or other household products. In addition, some online sites simply sell them as 'research' chemicals," lead author Erik W. Gunderson, MD, of the University of Virginia School of Medicine, in Charlottesville, told Medscape Medical News.

The products, which are commonly marketed as a "legal high," typically contain compounds that are derivatives of cathinone, the primary active alkaloid found in the herbal stimulant khat (Catha edulis), which is native to East Africa and the Arabian Peninsula and is still chewed as a social custom in those regions.

In the designer stimulant products, the compounds are commonly mephedrone, methylenedioxypyrovalerone (MDPV), and methylone. The products first gained popularity in Europe before catching on in the United States in about 2010.

No Effective Screening Test

Data from the American Association of Poison Control Centers indicate that telephone calls to poison centers regarding substituted cathinone stimulants increased from 0 in 2009 to about 300 calls in 2010 and soared to more than 6000 in 2011, a 20-fold increase from the previous year. The calls decreased in 2012 to about 2065.

Whether that reduction is a result of improved awareness, product regulation, or users learning to take the products in a way that does not land them in the emergency department remain unanswered, Dr. Gunderson said.

"One of the big limitations in the poison control and emergency room case report type of data is there is no denominator — we don't know the baseline population of people using these products. If there are 6000 people calling poison control, we still don't know how many people are using nationally, so there is pretty limited information about the prevalence of use," he added.

In comparison, the study revealed that there were 14,798 calls to American Association of Poison Control Ccenters for amphetamine and related compounds in 2009.

The key clinical effects related to acute toxicity with the designer stimulants are similar to those seen with stimulants such as amphetamines and cocaine, ranging from agitation, tachycardia, and combative violent behavior in more than 50% of cases to delusions/hallucinations, paranoia, seizures, confusion, and hypertension, according to 2 US case series reports.

Although the most common routes of administration in designer stimulant abuse are oral or intranasal, there are some reports of users combining both methods to obtain rapid and prolonged effects from the drugs.

One of the complicating factors among patients who present with symptoms is co-occurring substance abuse, and there is currently no effective screening test for the stimulants, Dr. Gunderson said.

With proper treatment, such as with benzodiazepines, symptoms typically resolve over several days; however, some cases can be serious or even fatal.

Potentially Lethal

In a separate 9-state analysis of designer stimulant hospital visits reported to poison control centers that focused on centers in the Midwest, researchers found that 16.1% of the more than 1600 cases reported from November 2010 to November 2011 involved serious medical effects or death.

The study, published in the Annals of Emergency Medicine, showed that users in the baby boomer age group had the highest risk for a major medical outcome (24.2%), and as many as 12.9% reported injection as the method of administration (Ann Emerg Med, published online 28 Mar, 2013).

Lead author Brandon J. Warrick, MD, of the Children's Hospital of Michigan Poison Control Center, in Detroit, speculated that the injection rate was higher with older users because they may be more experienced drug users.

"My guess is younger people are a little more wary of needles, whereas older drug users may have experience with that," he told Medscape Medical News.

In addition to having higher rates of injection, older patients may simply be more prone to worse outcomes.

"We can only hypothesize, but baby boomers are more likely to have comorbidities that can place them at a higher risk for more serious medical effects," he added

In Dr. Warrick's study, benzodiazepines were the most common treatment for toxicity, followed by sedation with a nonbenzodiazepine sedative such as propofol, barbiturates, and antipsychotics.

Dr. Warrick also published a case study of a healthy 24-year-old woman who died as the result of serotonin syndrome after ingesting 2 designer stimulant capsules sold at a concert as "ecstasy" and containing methylone and butylone (J Med Toxicol DOI 10.1007/s13181-011-0199-6).

The patient presented to the emergency department hyperadrenergic with serotonin excess. Benzodiazepines decreased myoclonus but did not fully extinguish it. She was aggressively cooled but progressed to multisystem organ failure and died. The case was said to be the first reported death for methylone or butylone.

"While this case is fairly typical for severe serotonin syndrome and/or sympathetic intoxication, it highlights the potential lethality of these drugs," the authors note.

"The case underlines our need to better understand the pharmacology mechanism of action, and optimal treatment of synthetic phenethylamine intoxication," they add.

Difficult to Regulate

Efforts to regulate designer stimulants in the United States have continuously hit obstacles that explain the continued legal sale of the products.

An analogue drug law enacted in 1986 was designed to prevent the need for new legislation each time chemists came up with new stimulants by making just small molecular changes to the psychoactive chemicals, but the act applies only to compounds intended for human consumption. Therefore, designer stimulants are able to skirt around the law with labels indicating "not for human consumption."

President Barack Obama signed a bill into law last summer that banned the sale of 31 specific designer chemicals, but with more than 1000 compounds of phenethylamines, the class to which cathinones belong, new products with different chemicals can be expected, the researchers said.

Likewise with the products readily available on store shelves or with the click of a mouse, more cases of toxicity can be anticipated.

"When these are being sold at gas stations and convenience stores right at the counter next to the candy on the counter, people tend to question how harmful these products truly are," Dr. Warrick said. "It's very easy for them to get a false sense of security."

Dr. Gunderson and Dr. Warrick have disclosed no relevant financial relationships.

J Addict Med. 2013;7:153-162. Abstract

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