2023-12-27 06:16:52
Several women have had quite a surprise in recent weeks, finding that their Prometrium progesterone capsules, a female hormone to combat the symptoms of menopause, were simply empty. The manufacturer says it has launched an investigation to shed light on this matter.
Updated yesterday at 7:00 a.m.
For a month, Cynthia*, who is in premenopause, felt that something was wrong. “I don’t sleep at night. I have heart palpitations. I have anxiety. It had already happened to me a few years ago before I took Prometrium, so I knew right away that it was a hormonal imbalance,” she says.
But the weeks passed and his condition did not improve. So she decided to stop working for two weeks. “I thought I was going crazy,” she confides regarding it.
At the beginning of December, Cynthia came across a post from the Bioidentical Hormones Facebook group indicating that one of the group members, Aline*, had noticed that her Prometrium capsules were harder than normal and especially empty inside.
“I said to myself: this doesn’t make any sense. That’s definitely what’s happening,” Cynthia explains. To find out for sure, she decided to open her capsules. Result: 20 of the 22 Prometrium capsules were empty. “I wonder how many people here in Quebec are going through this right now without knowing it,” says the woman who lives in the Estrie region.
An ongoing investigation
Aline has also been taking Prometrium capsules for several years to reduce her symptoms linked to menopause. Since the capsule gives her heartburn, she chews it to get the medicine in liquid form inside and throws it away once its contents are emptied.
After a while, I realized that the capsules were much denser or hard to chew and I started having symptoms, like night sweats, unexplained anxiety and my sleep was disturbed.
Aline*, resident of Bas-Saint-Laurent
Over the next few days, she said she heard a noise when chewing a capsule. “Like a pop of emptiness,” she illustrates. To find out for sure, she decided to pierce the capsules to check their contents. Out of ten capsules, four were completely empty. She then contacted the manufacturer of Prometrium, the company Organon, who offered to replace her medications.
In response to the request for The Press, the company Organon confirmed that its medical information center was recently informed of the situation. “An investigation is underway with the manufacturing site and we are awaiting the results of the investigation, which will determine the further actions to be taken, if necessary,” the company indicated by email, simply specifying that all Organon products are evaluated before they leave their manufacturing site.
“This should never happen”
“An empty capsule like that is the first time I’ve heard of this situation,” says Marie-Pascale Beaulieu, director of pharmaceutical services at the Quebec Association of Pharmacist Owners (AQPP). “In the industry there are quality controls, so it should never happen, situations like that. » She recommends that those affected seek advice from pharmacists, who have different alternatives.
Three other women also contacted The Press to report the situation. One of them, Corinne Chevalier, noticed in the last few days that some of her Prometrium capsules were less full than others. “I have a loss of confidence. Fluctuating hormones cause huge upheavals in women’s health,” notes the woman who has taken this medication daily for four years.
Ms. Chevalier also contacted the manufacturer Organon to warn it. “They tell us to go back and exchange it at the pharmacy. As if it wasn’t serious,” she laments. “A few months ago, there was a stock shortage of Estradot patches, now there is poor manufacturing of the drugs. It’s still medication for postmenopausal women. It’s like it’s not important. »
More than 20,000 women insured by the public plan take micronized progesterone, which includes Prometrium from Organon, according to the latest figures from the RAMQ dating from April.
* These women preferred to withhold their last name, as those around them were not aware that they were taking progesterone capsules.
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