Research published in 2014 showed that 74 of the 100 most commonly prescribed medicines contained one or more of lactose, gelatine or magnesium ingredients . Lactose was found in 59 of the drugs, magnesium stearate in 49 drugs, and gelatine in 20 drugs.
GRAHAM CLEWS: When most people think about consuming a vegan or vegetarian diet, their medicines are perhaps not the first thing that come to mind. However, many medicines contain excipients that are derived from animals, making it difficult for most people to avoid animal products entirely — but this might be starting to change.
In February 2022, the world’s first medicine to be certified to contain no animal-derived products by The Vegan Society went on sale in Germany. Paraveganio, a paracetamol product manufactured by Hamburg-based wholesaler Axunio, uses a plant-based source of the excipient magnesium stearate.
“The needs and preferences of vegan people are currently completely being flouted,” says Julia von Horsten, the company’s product and business development manager. “For that reason, we wanted to give them access to the first certified vegan product and pave the way to more transparency and awareness for the vegan lifestyle within the pharma sector”…
Nevertheless, it is difficult for vegans and vegetarians, as well as those practising religions that forbid some consumption of animal products, to know which medicines align with their beliefs. Research published in The BMJ in 2014 showed that 74 of the 100 most commonly prescribed medicines in primary care contained one or more of the excipients lactose, gelatine or magnesium stearate (see Figure). Lactose was found in 59 of the drugs, magnesium stearate in 49 drugs, and gelatine in 20 drugs.
According to the Specialist Pharmacy Service (SPS), gelatine is often used in capsules, tablets, as part of modified release preparations, or to thicken liquids, and is usually derived from the skin and bone of cattle and pigs. Lactose, used as a diluent, is generally produced from milk. And magnesium stearate, used in the production of both tablets and powders, is most commonly derived from bovine tallow, a form of beef fat, although it can also be produced from plants.
Both the summary of product characteristics (SPC) and patient information leaflet provided with all authorised drugs include a list of excipients, but it is not always possible to determine which ingredients are derived from animals from this information… The SPS advises that to confirm the suitability of a product for use by someone who wants to avoid animal products “involves checking the licensed product information and contacting the manufacturer directly”.
However, it also warns: “Sometimes, pharmaceutical companies cannot guarantee or differentiate the specific sources of animal-derived ingredients, as various suppliers are used in the manufacturing process and the sources can change”… Samantha Fry, a hospital pharmacist and vegan, advises patients to check the manufacturer’s website for information on branded products…
Kendal Pitt, senior technical director for solid oral dosage forms at the pharmaceutical company GlaxoSmithKline, explains that magnesium stearate, gelatine and lactose are the “big three” in terms of animal-derived products in the production of medicines. The vast majority of active pharmaceutical ingredients are synthetically produced with very few from animals, he adds. “Most large drug companies have had a policy of removing animal products whenever they can for the last ten years, driven by public demand,” he explains.
Work on shifting magnesium stearate production away from animal products began 20 years ago, prompted by worries over transmissible spongiform encephalopathies (TSE), he says. Manufacturers have also been working on shifting from the use of hard gelatine, such as in capsules, initially to make sure that drugs were acceptable for people for religious reasons, because the main sources of gelatine are cows and pigs. Lactose use has only recently come onto the radar, he says, but firms are now looking at vegan alternatives, which has caused a decline in lactose use across newly-marketed products.
Pitt says it is difficult to estimate the proportion of drugs that have removed all animal products from the manufacturing process, and there is no source of industry-wide data. As an indication, a search of the MHRA database of product information, carried out at the end of August 2022, shows that 2,732 products contain gelatine capsules in their SPC, compared with just 106 for hydroxypropylmethylcellulose (HMPC) capsules, one of the main vegan alternatives…
Pitt adds that when making medicines animal-free, it is generally simpler for manufacturers to bring new products to the market. “A replacement for an existing product can trigger the need for a bioequivalent study, which can be expensive, and can make a switch uneconomic,” he explains… Fry agrees: “As veganism has grown so rapidly recently, there is the potential over the next five years for a jump in the number of patients who will expect a vegan option for their medication… One of the biggest issues for patients who do not consume animal products is that they are simply unaware that many medicines would be unsuitable for them to take.
In 2004, a small study of 100 patients and 100 doctors in the United States found that 84% of patients were unaware that medicines included products derived from pork or beef, and 70% of doctors did not know that some drugs included animal-based products that would contravene their patients’ religious beliefs. Fry says that the “vast majority” of vegan and vegetarian patients she speaks to have not thought about medicines as possibly containing animal products.
“Most have been happy to accept an approach of supplying a vegan or vegetarian formulation where possible and not worrying about the ones that can’t be changed. “All have been unbelievably grateful that we took the time to have the conversation, but it is a huge time pressure when it happens.” She is hopeful that a rise in veganism will see the attitude among manufacturers to animal products in medicines continue to evolve, but she warns: “Until patients start demanding this in bigger numbers, I don’t think the situation will change”. SOURCE…