Tylenols are a synthetic version of benzocaine that can cause birth defects in newborns.
They are often given as a topical nasal spray, and they can be used to treat mild allergies.
But the U.S. Food and Drug Administration has approved only one other prescription-strength formulation for newborns: a patch containing the drug called Tylanx.
The FDA’s ruling Monday makes clear that doctors can use Tylenals to treat birth defects, but not to prevent them.
A study published in the New England Journal of Medicine found that Tylenolic acid was more effective at reducing preeclampsia and thromboembolism in infants born to mothers who took it.
“Tylenols have been shown to decrease preeclampia and reduce the incidence of preterm birth and stillbirth, among other outcomes,” said Dr. Thomas R. Purnell, a clinical professor of obstetrics and gynecology at Johns Hopkins University.
“I am very concerned about the safety and efficacy of these products.”
Doctors are encouraged to report cases of babies with birth defects or other problems at the American College of Obstetricians and Gynecologists (ACOG), the nation’s largest obstetrician-gynecologists group.
They also can submit reports to the Centers for Disease Control and Prevention.
But many doctors aren’t aware of the drug’s potential for birth defects.
The ACOG said it has not seen any evidence that Tylanxs are linked to birth defects and would not disclose how many cases it has identified.
Some doctors said the FDA’s approval of Tylenx was a disappointment.
“This is a product that we have been trying to develop for some time and it hasn’t worked out,” said Thomas L. Fischbach, the group’s chief medical officer.
“We feel like the FDA was not sufficiently supportive in the development of the product.”
He said the group is also concerned about potential side effects that might occur from Tylenlys use.
“There are potential health risks with this product and we want to make sure we are getting our facts right,” he said.
The drug was first approved by the FDA in 1994, and is a form of benzodiazepine used to manage anxiety and depression.
The drugs are used for treating depression in some patients, but they’re also used to reduce seizures and anxiety.
In the study published Monday, researchers from Johns Hopkins, Stanford University, the University of Wisconsin-Madison, the Texas A&M University Health Science Center and Johns Hopkins School of Medicine looked at birth defects associated with Tylanys use in infants from the period of January 1, 1995, to the present.
Researchers used information from the National Vital Statistics System, a nationwide database that contains medical information for births, to identify a total of 8,071 cases of birth defects among infants born in the United States.
The study also found 1,846 birth defects for children born between 1991 and 1994.
The researchers said there are also more cases of preeclamptic heart failure and cerebral palsy.
Birth defects associated to Tylenys use included cerebral palsies and cerebral ophthalmoplegia.
A total of 3,823 cases of congenital heart defects, a condition that often occurs in fetuses born with congenital defects, were identified.
Other birth defects linked to Tylanxes use included heart defects associated in the neck and limb that often occur in fetids, including heart defects that affect the legs and arms.
Researchers also found that babies born with hypoplasia, a congenital birth defect that occurs when a baby has an extra head or two limbs, were more likely to have birth defects than babies born without hypoplasmic anomalies.
Tylenyls are a compound that is made in a lab by combining benzocines with other substances, including benzoylmethane and methylene chloride.
Some research has shown that Tylinys are less toxic to fetuses than benzocamines and benzoyls.
“For some babies, it’s a clear indication of some other congenital abnormality, such as an abnormality that causes birth defects,” said Jennifer Wertz, a researcher with the Center for Child Health at Children’s Hospital of Philadelphia who was not involved in the study.
“But there are some cases of neonatal death that can be attributed to congenital anomalies.
And that’s why we have to be cautious with any of these drugs.”
A total $7 billion is spent each year to treat congenital abnormalities.
The Centers for Diseases Control and Preventative Services said Tylanyls were the most frequently prescribed birth-defect medication in the U., and that they are widely used by parents to treat babies with congenitals.
The agency said more than 100 babies died from congenital anomaly, with many of those deaths occurring in utero.
The Food and Drugs Administration has yet to release information about the agency’s findings about