Justifying its ban on the medicine, the US FDA said it "reviewed several incidents of serious adverse events associated with the use..."
Despite its ban in several countries, Apetamin syrup - an appetite stimulant used for treating allergies and for weight gain by some - is sold openly across pharmacies in Nigeria without regulation. In this report, DUBAWA's Elizabeth Ogunbamowo investigates the health risks posed by the medicine and how regulatory lapses aid its unchecked sale in Africa's most populous country.
Decisions, it is often said, can make or mar a person. Years ago, Ms Indijo took one that almost cost her life.
In 2016, one of her friends recommended Apetamin, a nutritional supplement for weight gain, which she immediately embraced.
"I tried it (Apetamin) for overall weight gain. It did open up my appetite for me to eat more. But it also made me very sleepy. And it hurt my stomach," she told DUBAWA.
Mrs Indijo's friend who recommended the medicine to her was neither a medical doctor nor had any medical knowledge.
While Ms Indijo, who asked only to be identified by her last name, claimed it worked for her friend, hers was the contrast. At the first attempt in 2016, she did see results but they did not stay. In 2018, she decided to try it again with the hope of a permanent desired result.
Not long after her resolve to use the medicine on a consistent basis, she noticed scary side effects.
She developed bruises, which prompted her to see a doctor. She was hospitalised and diagnosed with immune thrombocytopenia (ITP), a bleeding disorder caused by her use of Apetamin. She said her haematologist told her that the cyproheptadine, an ingredient in Apetamin, had lowered her platelet count.
Ms Indijo added that she had been living with the chronic condition for six years but remains determined to overcome it.
The dangerous side effect of Apetamin
Ms Oluwadarasimi, as she asked to be identified, is also glad to be alive to share her experience with Apetamin.
For years, she had wanted to put on weight to match her desired body physique but none of her efforts came through. That, however, did not deter her because, for her, it was a fight to finish.
"I actually wanted to gain weight so badly, then I told my friend about it because it has always been difficult for me to add up no matter what I eat," she told DUBAWA.
In 2023, Ms Oluwadarasimi's friend recommended Apetamin as the solution to her problem. As with Ms Indijo's experience, her friend who recommended the medicine had no medical knowledge.
Being desperate to gain weight at all costs, she did not think twice before buying the idea.
At first, it appeared to be the game-changer. "It (Apetamin) made me eat and sleep well," she said when asked about her initial impression of the medicine.
But barely three days after she started using the medicine, she experienced severe side effects, including stomach pain.
When asked if she got the desired result, she quipped: "No! I stopped using it after trying it for three days. I noticed some severe side effects which are so dangerous. Anxiety almost killed me for real. My heart started beating faster than normal."
The risks outweigh the benefits
For Olorunfemi Raymond, his experience with Apetamin is one he would not forget in a hurry. The Lagos-based entrepreneur told DUBAWA that he once used Apetamin for weight gain.
He said the medicine was recommended to him by an official at a local medicine store, where he had gone to inquire about medicine or supplements that could boost his appetite and help him gain weight.
A few days later, Mr Raymond wished he never took the advice given to him at the local drugstore. He said that his stomach started hurting badly after taking it.
Mr Raymond said he initially dismissed the pain as one of the side effects of the medicine and assumed it would go with time but to his surprise, the stomach ache got worse.
"This (the stomach ache) made me stop using the medicine immediately and I never returned to it," he explained.
The 36-year-old said while he ate "more and slept well" during the period he used the medicine, "the risk outweighs the benefits", adding that this experience made him stop taking it.
What is Apetamin?
Apetamin is an appetite stimulant and weight gain supplement. It is manufactured by TIL Healthcare Pvt Ltd, a pharmaceutical company in Chennai, India. It is marketed and distributed in Nigeria by Grace Drugs & Healthcare Ltd located at 1A, Ogunlana Drive, Surulere, Lagos State.
Checks on the chemical composition of the product by DUBAWA showed it contains cyproheptadine hydrochloride (anhydrous), L-lysine hydrochloride, thiamine hydrochloride, hydrochloride, nicotinamide and dexpanthenol.
The active ingredient in Apetamin is cyproheptadine, a potent antihistamine that requires a physician's prescription, according to the US Food and Drug Administration (FDA). A 2020 study also established that the medicine contains cyproheptadine, a known hepatotoxin (a toxic chemical substance that damages the liver).
Originally, Apetamin was introduced to treat weight loss symptoms associated with illness and allergies, not for people in good health.
In recent years, however, many Nigerians have embraced the medicine as a quick fix for weight gain and figure augmentation. The use of Apetamin primarily for weight gain has been disputed by several studies and government agencies globally due to its potential risks and the experiences of those who have used it. In the 2020 study published in ACG Case Reports Journal, researchers found a 40-year-old woman, previously healthy, who suffered drug-induced autoimmune hepatitis after six weeks of daily Apetamin use.
The study said the woman experienced fatigue, right-sided abdominal discomfort, and jaundice weeks after she started using the medicine "which she learned from social media for figure augmentation."
Due to its potential harm, Apetamin is considered illegal in several countries including France, the United Kingdom and the US. Justifying its ban on the medicine, the US FDA said it "reviewed several incidents of serious adverse events associated with the use of Apetamin, which is being marketed illegally for weight gain and figure augmentation".
The FDA noted consumers may be unaware of the serious risks associated with cyproheptadine in Apetamin, including sedation, dizziness, cognitive impairment, and dangerously low blood pressure. It added that overdose can lead to severe effects such as confusion, hallucinations, convulsions, and even death, especially when combined with alcohol or other depressants.
In Canada where the use of the medicine for weight gain is allowed, its use is strictly recommended on the advice of a medical expert to prevent abuse.
Banned and regulated in many countries but free for all in Nigeria
In Nigeria, Apetamin is one of the go-to appetite-boosting products for people seeking to gain some weight and enhance their looks.
Despite concerns over the use of Apetamin globally, it is not properly regulated in Nigeria.
By law, the National Agency for Food and Drug Administration and Control (NAFDAC) is authorised to regulate and oversee the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents.
The agency, established to protect public health through regulation of food and drugs, has failed to regulate the sales of Apetamin, which is sold openly at major supermarkets and pharmacies across Nigeria.
Apetamin everywhere
To ascertain the spread and accessibility of the product and to determine if there is any form of control over the sale of the medicine in the country, DUBAWA's reporter visited eight pharmacy stores in Lagos state. Findings showed the product is easily accessible without any form of control. While four of the eight pharmacies visited had the product in stock, the remaining four explained it was not available and asked DUBAWA's reporter to come for it at a later date.
At Justrite Pharmacy located in Abule Egba, Alimosho local government area of the state, DUBAWA's reporter bought the medicine for N6,000 without hassle. No prescription note from a medical expert was required.
A similar experience played out at other pharmacies visited as the medicine was sold over the counter. At Bydow Pharmacy, located at Abeokuta Express Way, by U-Turn, Abule Egba, Lagos, the product was sold for N7,350.
When DUBAWA visited Josfekmart Pharmacy Limited along Ekoro Road in Lagos, the attendants told this reporter that the medicine goes for N6,000 while at Civic Pharmacy, also on Ekoro Road, the product was sold for N6,500.
It is dangerous to take without medical supervision
A look at the label of the 200ml Apetamin bought showed it contained a "caution", which reads: "It is dangerous to take this preparation except under medical supervision".
The caution on the label further reads: "Some individuals may feel drowsy when first taking Apetamin syrup. If this happens, they should not drive a vehicle or operate machinery or appliances requiring alertness."
The warning contained on the medicine's label clearly highlighted the danger of using it without any form of medical supervision. This also suggested it ought to have been tagged as a prescription-only medicine.
However, it is sold to everyone in Nigeria without a prescription due to regulatory lapses, which puts more Nigerians like Ms Oluwadarasimi who still consider the medicine as the solution to gaining weight at risk.
"I got it without a prescription at a pharmacy in Nigeria," Ms Oluwadarasimi said, corroborating DUBAWA's findings. She, however, declined to mention the name of the pharmacy for safety concerns.
Further checks showed the medicine was approved by NAFDAC, with registration number A7-4783. To establish if the purchased medicine was genuine or fake, DUBAWA used the Mobile Authentication Service (MAS) scheme, which is one of the anti-counterfeiting strategies initiated by NAFDAC to check substandard and falsified (SF) medical products. The scheme uses scratch codes and a Short Messaging Service (SMS) for consumers to verify the authenticity of medicines at the point of purchase. Adopting this, DUBAWA sent the scratch code on the label - 3045305053247 - to 38353 on Aug 20, 2024.
Shortly after, a response was received confirming that the medicine was genuine. "Ok. Genuine Apetamin," the terse message, which also contained the medicine's NAFDAC registration number, reads.
Apetamin without NAFDAC number
In addition to being sold without a prescription, another major evidence of regulatory lapses observed by DUBAWA was the fact that variations of the medicine without the NAFDAC number were sold to members of the public.
DUBAWA's reporter experienced this during a visit to MAMS Pharmacy and Stores at Agbelekale in Alimosho LGA of Lagos State. When the reporter inquired if the medicine was available, the male attendant replied in the affirmative but with suspicion written on his face.
"Yes, we have it, just that this one doesn't have NAFDAC registration number. It's the same thing. It is sold for N6,000," he said.
Sensing the reporter's reaction to the fact that the medicine being sold had no NAFDAC registration number, another official, who appeared to be the supervisor, weighed in to calm the situation.
"There are two types of this product (Apetamin). One is imported and the other is Nigerian made. The one produced in Nigeria has NAFDAC (registration) number but the imported ones are not registered with NAFDAC," he said.
"The imported one has this dull orange colour on the pack while the locally made ones have bright orange colour on the pack."
Though startled by the revelation, the reporter feigned being convinced by his explanation and eventually bought the product for N5,500 after haggling the price.
Selling medicine not registered by NAFDAC is illegal in Nigeria. Further check on the label of the product without the NAFDAC registration number also showed it lacked a scratch code for confirming its authenticity, which portends dangers to unsuspecting members of the public.
Peter Akhidenor, a clinical pharmacologist, warned that cyproheptadine, a key ingredient in Apetamin, can cause severe side effects such as arrhythmias, heart attacks, and QT interval prolongation, especially when combined with other medicines.
He told DUBWA that the medicine, often misused for weight gain, is unsafe for chronic use and should only be available by prescription.
"It (Apetamin) should be prescribed-only but how many prescribed-only medicines are monitored? Just like they abuse tramadol. People do it and get away with it," he noted
Francis Agbaraolorunpo, a physiologist and lecturer at the University of Lagos (UNILAG), told DUBAWA that some anti-histaminic products, such as Apetamin, have sedative effects.
He advised people to see a doctor instead of self-medicating, noting that in many Western countries, medicines are strictly controlled and need a doctor's prescription, unlike in Nigeria. Mr Agbaraolorunpo also explained that weight is mostly genetic and recommended natural ways to gain weight, like eating a balanced diet and getting enough sleep.
Social media analysis of Apetamin advertisements
Findings show there is a restriction on the sale and advertisement of Apetamin syrup on TikTok. The word Apetamin is flagged for "behaviour or content that violates the guidelines." However, users who are also sellers or recommenders of the product use other phrases such as "apetami", "apetaminsirop" to bypass the platform's algorithm.
Other hashtags include #apetaminplug, #apetaminsyrup #thicksyurp #skinnygirlproblems #gainweight #healthtips.
DUBAWA identified accounts that subtly recommend the syrup to users for weight gain. Some of them are It Girl Dime, Monae Herron, the real bubbles, Miss Wisdom, Anikemi and Dom Weight gains.
Searching for weight gain on TikTok, there appeared to be hundreds of pages recommending different kinds of syrups, tablets, and shakes, either factory made or locally produced.
Instagram states that the term is associated with the sale and use of drugs and advises users to seek help if they think they are suffering from addiction but gives room to search further which is not available on TikTok.
On Facebook, Apetamin ads are almost impossible to miss. A simple search will reveal several posts, pages, and groups openly promoting the medicine, complete with enticing visuals and direct links to sellers. The lack of restrictions in the search bar makes Facebook a bustling marketplace for Apetamin, where connecting with vendors is as effortless as scrolling through your feed. The volume and visibility of these ads showed how pervasive and unchecked the promotion of this controversial medicine has become.
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Analysis of X shows that users do not buy and sell the product via the app but only discuss its side effects or recommend it to other users. We also found no restrictions whatsoever on this platform.
Users who have taken Apetamin use a visual representation of before and after to show how well they gained weight "in the right places" using Apetamin syrup as an effective method of advertising or recommending the syrup.
Given the nature of social media, it is quite easy to connect with sellers via all of these platforms regardless of where they live in the world and get it delivered to the end users.
Meanwhile, the NAFDAC law states that any product, food, cosmetics, or drugs, amongst others, that will be sold in Nigeria must be registered by the agency before its sale and distribution.
Food, Drug and Related Products (Registration) Act Cap F.33 prohibits "the manufacture, sale, distribution and advertisement of unregistered food, drug product, cosmetic, medical device or water".
NAFDAC responds to DUBAWA's inquiries on Apetamin
On 11 September, DUBAWA sent a request under the Freedom of Information (FOI) Act to NAFDAC concerning Apetamin. The request sought to establish, among other things, whether the medicine is registered and approved by NAFDAC for use among Nigerians because it is not listed in NAFDAC's Greenbook, a comprehensive database of registered drugs in Nigeria.
It also sought to know if the agency classified the medicine as a prescription-only (POM) or Over-the-counter (OTC) medicine, considering its cyproheptadine content.
Similarly, the FOI sought to understand why the medicine is not listed on NAFDAC's Greenbook and the measures taken to avoid its abuse by some Nigerians.
By 19 September, the agency, in a response signed by Offiah Nneka, its FOI desk officer, on behalf of Moji Adeyeye, NAFDAC's Director-General, acknowledged DUBAWA's message but requested "for an extension of time to respond".
In its final response, which came in October, NAFDAC confirmed that the product is registered. The agency also said it is collaborating with other stakeholders to prevent abuse of medicines, including Apetamin.
NAFDAC, however, kept mum on whether the medicine is designated as prescription-only medicine or over-the-counter medicine.
"The product - Apetamin Cyproheptadine Lysine and Vitamins Syrup is registered by NAFDAC with NAFDAC number: A7-4783. The product is not yet on the NAFDAC Greenbook because the Agency is in the process of updating the website to include all prescription-only medicine (POM), over the counter (OTC) medicine and nutraceuticals. NAFDAC in carrying out its mandate to safeguard the health of Nigeria is collaborating with all relevant stakeholders to curb the abuse of drugs in Nigeria. NAFDAC has stopped the registration/renewal of this combination," part of NAFDAC's response read.
Although NAFDAC said it "has stopped the registration/renewal of this combination (referring to the chemical composition of Apetamin)," it did not provide enough details on it.
"NAFDAC will not entertain new applications for the registration of imported regulated products on the Federal Government Import Prohibition List, NAFDAC Ceiling List and Banned formulations," the agency had said in its 2023 statement.
It remains unclear if Apetamin has been placed on the federal government import prohibition list as well as NAFDAC ceiling list and banned formulations.
On 7 October, DUBAWA sent an email to TIL Healthcare, the producer of the medicine, requesting its response to the findings of this investigation. As of the time of publishing this report, the India-based company is yet to respond.
