Women who discovered their menopausal symptom medication was missing from their capsules should have answers soon. The manufacturer of Prometrium will release its final investigation report into empty capsules in early January.
Health Canada has confirmed The Press be aware of the reported issue regarding Prometrium. “The Ministry is in contact with the company to determine next steps,” said Joshua Coke, media relations.
Earlier this week, The Press reported that several women were surprised to find that their Prometrium progesterone capsules, a female hormone to combat the symptoms of menopause and used in fertility treatments, were simply empty. The manufacturer Organon said it had launched an investigation to shed light on this matter.
Health Canada specifies that in the event of concerns related to the quality of a health product, the company is required to investigate and take appropriate measures to correct the situation. “Multiple actions can be taken to correct non-compliance or mitigate risks to the public, including recalls, public communications or product seizures,” says Coke. Currently, there is no recall of the drug.
If patients have questions or concerns about Prometrium, Health Canada encourages them to discuss them with a healthcare professional, such as their doctor or pharmacist. The federal agency also encourages affected people to report any side effects or complaints to it.
For its part, the manufacturer Organon said it plans to obtain the final investigation report during the week of January 8. “Based on the preliminary report received on December 22, 2023, no evidence has been identified that would confirm the reported defects,” Organon spokesperson Dominique Quirion said by email. The company recalled that all of its products are evaluated before they leave their manufacturing site.
There is also a shortage of Prometrium on the Canadian market due to an increase in demand which has exceeded the capacity of Organon’s supply chain. The company is “still working to remedy this,” Ms.me Quirion.
” It shocks me ”
Prometrium is regularly used to relieve the symptoms of premenopausal women, indicates the DD Gabrielle Landry, family doctor and founder of the DGL Center for Hormone Therapy. If patients ingest empty capsules, they may experience a return of their symptoms such as increased anxiety, insomnia, joint pain and difficulty concentrating, she explains.
For their part, postmenopausal women who take estrogen and progesterone daily and find themselves with empty capsules may experience bleeding, warns the DD Landry. Some doctors will even order an ultrasound or endometrial biopsy to find the cause of the bleeding.
This was the case for Lucie Carrière, who has been in menopause for four years and who takes Prometrium daily. In the last few weeks, she has had heavy periods. “I went to see my doctor, who sent me for a pelvic ultrasound and referred me to my gynecologist,” she says.
Her gynecologist recommended she have a biopsy. “The whole time I was worried. I thought it could be uterine cancer. » However, since she started a new box of Prometrium last week, her periods have ended. “I would have liked the company to send a press release to warn us. It shocks me. »
Pierce its capsules
The saga of the empty capsules proved costly for Isabella, who preferred to withhold her last name because those around her were unaware that she was taking progesterone capsules. In recent months, the woman has paid several hundred dollars for private medical appointments to establish the correct dose of Prometrium.
However, she recently noticed that some of her capsules were empty or seemed less full than usual.
For three months I took capsules without knowing if they were full or empty. I spent all that money privately for nothing. My blood tests are not good. I’m going back to zero.
Isabella, who takes progesterone capsules
The DD Landry advises women to puncture the capsule with a sterile needle before ingesting it to ensure it contains fluid. They may also chew it rather than swallowing it to ensure the medicine is present. “It has a little subtle taste, so not everyone will be able to know that there is product that came out when chewing it,” warns the D.D Landry. She points out that generics of the drug are also available.
In fertility, Prometrium vaginal capsules can also be given to promote implantation of an embryo in the uterus. “Since it is intravaginal, women do not have the option of chewing it, so there is no way to see if there is a product inside,” explains the family doctor.