Fertility drug makers are refusing to supply doctors with a new version of their injectable medication, a sign that some doctors may have trouble with it.
The new injectable version of metformil, known as FCT-16, is not approved for use by pregnant women and does not contain enough active ingredients for doctors to safely prescribe it, said Dr. Steven Kappel, a professor of obstetrics and gynecology at the University of California San Francisco and one of the country’s leading experts on metformins.FCT-8, also known as metformol, is approved by the FDA for use during pregnancy.
But the FDA has not approved FCT for use in women with fertility problems, or people who have recently given birth.
“This is a very new and untested drug, so I don’t know how it’s going to perform,” said Kappen, who has worked with some of the drug makers.
He and others who work in the field have warned that the drug is unsafe and should not be prescribed to women with unexplained infertility.
The FDA did not respond to a request for comment.
A recent FDA survey showed that about 60 percent of the doctors who used FCT at least once in the past year reported having concerns about its safety.
Kappelman, who is also a clinical professor of medicine at the UC San Francisco School of Medicine, said he had received emails from doctors who had not been able to use the drug because it was so difficult to administer.
“I don’t think there’s any way to know whether this is a problem for doctors, or whether this has a different impact on patients,” Kapplin said.
Fertility medications are widely used in the United States, but there is no approved test for infertility, which can be caused by a variety of causes.
The FDA has issued more than 2,000 advisories on the safety of the medications, including ones for heart conditions, diabetes and stroke.
The American Academy of Family Physicians said it has been “very concerned” about the safety and effectiveness of FCT.
The group said it wants the FDA to immediately review the drug and prescribe a new, approved version.
“It is important to emphasize that the FDA is committed to protecting the safety, well-being and health of women in all forms of family planning,” the group said in a statement.
Fertilization clinics have been hesitant to prescribe FCT because of concerns about side effects and side effects associated with metformis, Kappeln said.
The drug, which has not been approved for that purpose, is used to help women conceive during the first trimester.
Some doctors said they were not familiar with the new drug.
Koffel said some of his patients have asked him if they should take it, and some women who are pregnant have asked for it.
“My concern is that I have a patient that’s pregnant and I don, and I can’t get her pregnant,” Koffeln said, adding that it is not clear whether she will be able to get pregnant if she is using FCT in the future.
Kappel said the FDA needs to get a better handle on how the drug works and why it is so difficult for doctors and patients to administer the drug.
He said he worries that doctors may find the drug difficult to use for women with health problems.
He also said he is concerned that some of Fretilizer’s users have been using it to get ahead of their doctors in their careers.
“If you’re going to have to take it on a whim to get out of bed and you’re getting all these benefits that you’re not getting with other therapies, then I think it’s very important that they be aware of what’s happening to them,” Koppel said.