Doctors, pharmacists wary of risks in making weight loss drug available OTC

Previously, weight loss medications in Estonia have been prescription-only. Now, Orlistat is available over-the-counter (OTC) in Estonian pharmacies, even as doctors and pharmacists are wary of potential risks.
Multiple pharmacists say they have already seen interest in Orlistat, despite its short time on the market as an OTC drug. There are pharmacy customers who want to buy the drug for themselves as well as those who have come to purchase it for someone else.
"It's only for a very short time that it's been on the market here as an OTC drug, but there is interest in it, and that interest is growing," acknowledged pharmacist Kristina Suvorova.
According to the State Agency of Medicines (RA), the drug is suitable for OTC sales because it meets the criteria for such medications. For example, its indication for use — being overweight, in this case — is easily diagnosable.
"Another criterion is that, when used as directed in the product information, side effects should be mild and predictable," explained Maia Uusküla, director of the Department of Post-authorization Safety at RA.
"The third is that the method of administration must be relatively simple, and thanks to that, Orlistat fits the criteria for an OTC drug," she added.
However, family doctor Ruth Kalda as well as several pharmacists see multiple risks to making this drug available over-the-counter.
"When we used to prescribe [this] medication, then that also involved counseling covering everything that could happen," Kalda explained. "Now, if a patient can buy it OTC, which may not involve such thorough counseling, they could experience side effects — and possibly unexpectedly."
"When we allow a drug to be sold OTC, the risk of misuse increases significantly," Suvorova warned. "In this case, the responsibility falls entirely on the patient using it. But when a drug requires a prescription, that responsibility is also shared with the doctor prescribing it as well as the pharmacist dispensing it."
According to the medication's product information, Orlistat is intended for weight loss in overweight adults over the age of 18 with a body mass index (BMI) of 28 or higher. However, if someone who does not actually need the drug wants to purchase it, a pharmacist can only offer them counseling.
"We also have a lot of people with eating disorders who may not need this medication — for example, if their BMI is not above 28," noted pharmacist Aleksei Morgunov. "If it's available OTC, they can take it, and that increases the risk of side effects. The issue is also that people will often see an advertisement, but that ad doesn't indicate the risks the drug involves. While the packaging may say to consult with a doctor or pharmacist, people won't always do that."
RA still recommends patients consult with a doctor or pharmacist before taking this medication, as well as checking the product information for potential drug interactions.
Uusküla explained that Orlistat works by inhibiting an enzyme that breaks down fat. As a result, this fat remains undigested and is excreted.
"This also means that medications requiring fat for absorption — including fat-soluble vitamins — won't be absorbed properly, which could reduce the effectiveness of many drugs," she highlighted. "All these interactions are listed in the product information leaflet. We hope pharmacists will also advise people accordingly that they should critically assess what they are taking and whether Orlistat is right for them."
RA does not expect other weight loss medications to become available OTC in Estonia anytime soon.
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Editor: Merili Nael, Aili Vahtla