Prolonged Use of Tylenol While Pregnant May Cause Infertility in Baby Boys

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A new study published in Science Translational Medicine shows that pregnant women who use Tylenol for prolonged periods of time may give birth to baby boys with fertility problems.

Scientists at the University of Edinburgh in the United Kingdom grafted human testicular tissue onto mice, and then divided them into two groups: one group received acetaminophen, the main ingredient in Tylenol, for 24 hours, and the other group was given the daily drug for seven days. After measuring testosterone production an hour after the last dose in both groups, scientists observed no effect in the mice given acetaminophen for 24 hours. This was not the case in the second group, however; the team found that group had a 45 percent reduction in testosterone, according to Toronto Sun.

Tylenol is popular among pregnant women because it has for years been considered a safe, over-the-counter (OTC) painkiller. According to university researchers, lower exposure to testosterone in the womb has been linked to a greater risk of male infertility, undescended testicles and testicular cancer. While the study was performed only in animals, the scientists are urging pregnant women to be cautious about the length of time they take Tylenol for aches and pains.

“We would advise that pregnant women should follow current guidance that the painkiller be taken at the lowest effective dose for the shortest possible time,” Dr. Rod Mitchell of the University of Edinburgh said in a news release obtained by Toronto Sun.

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University of Massachussetts Amherst Epidemiologist Examines Possible Connection Between Phthalates and Breast Cancer

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A University of Massachussetts Amherst epidemiologist has been awarded a three-year, $1.5 million grant to investigate a potential link between phthalates and breast cancer.

Phthalates are plasticizing, solvent chemicals found in products such as cosmetics, shampoos, flooring and medical tubing. Scientists have wondered for a long time whether phthalates impact human breast cancer risk, but lacked reliable data to draw a conclusion. Epidemiologist Katherine Reeves is on a mission to investigate phthalate metabolites – products found in urine samples after the chemicals have passed through the body – as nearly 100 percent of the U.S. population has measurable phthalate metabolites in their bodies, according to The Recorder.

Only a small handful of studies have examined whether phthalates affect human breast cancer risk, and none of them measured phthalate metabolites before a cancer diagnosis. For the study, Reeves, along with UMass Amherst biologist Thomas Zoeller, an expert in endocrine-disrupting chemicals; epidemiologist Sue Hankinson, and biostatistician Carol Bigelow will analyze levels of 11 phthalate metabolites in urine samples collected from 500 women with invasive breast cancer after Year 3 of follow-up and in 1,000 healthy matched controls. The study is nested within the Women’s Health Initiative, The Recorder reported.

“This study, where the samples were given many years before any sign of disease appeared, will give us much stronger evidence in terms of causality than studies using another design,” Reeves told The Recorder.

Researchers stored urine samples from baseline, Year 1, Year2 and Year 3, which will allow them to address variation in phthalate exposure. Reeves told The Recorder that she hopes “to provide not more uncertainty, but instead either reassurance or solid evidence of cause for concern” through the study. “It is well designed and large enough so no matter what answer we find we can have confidence in the result,” she added.

The study will seek to determine whether associations between phthalate metabolite levels and breast cancer vary by disease characteristics like hormone receptor status and personal factors including, age, postmenopausal hormone therapy use and body mass index, The Recorder wrote.

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Boy’s Future Fertility Could be Affected by Mother’s Acetaminophen Use in Pregnancy

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A study from the United Kingdom, published in Science Translational Medicine, suggests that prolonged exposure to acetaminophen during pregnancy could lower a boy’s production of testosterone, possibly affecting his future fertility.

If the expectant mother takes acetaminophen for several days it could affect her unborn boy, lowering his future sperm count, Medical News Today (MNT) reports. Acetaminophen is a widely used over-the-counter pain-reliever and fever-reducer that is sold under brand names including Tylenol and in generic and house brands.

The study’s authors explain that the risks of low testosterone in developing male fetuses include such disorders as undescended testis (cryptorchidism) and hypospadias, a urethral malformation in which the urine outlet is not in the normal position at the end of the penis. In young adulthood, the boy could experience low sperm counts and testicular germ cell cancer can develop, according to MNT.

Pediatric endocrinologist Dr. Rod Mitchell, a Wellcome Trust clinical research fellow at the University of Edinburgh and one of the study authors, says the study “adds to existing evidence that prolonged use of acetaminophen in pregnancy may increase the risk of reproductive disorders in male babies.” If a pregnant woman needs acetaminophen, she should take “the lowest effective dose for the shortest possible time,” Mitchell says.

To examine the effects of acetaminophen on testosterone production, Dr. Sander van den Driesche and colleagues at the MRC Centre for Reproductive Health at the University of Edinburgh grafted fragments of human fetal testes into castrated mice. Xenograft—the surgical grafting of tissue from one species to an unlike species—allowed the researchers to avoid problems in trying to measure testosterone production in unborn human males. The authors say their model “reflects physiological development and can be used to test the effects of chemical exposures on testosterone production,” according to MNT.

To conduct the experiment, the researchers gave the grafted mice a dose of acetaminophen equivalent to a human dose of 20 mg per kg three times a day for seven days. Testosterone levels in their blood dropped by 45 percent and the weight of the seminal vesicle glands fell by 18 percent. Seminal vesicles secrete the semen fluid, and the researchers used the weight of the vesicles as a biomarker of exposure to testosterone. The results were compared to those for mice receiving a placebo that contained no acetaminophen. Exposure to acetaminophen for a single day did not affect the measures of testosterone production.

While the researchers say further research is needed to understand how acetaminophen affects testosterone production in male fetuses, they advise caution in extended use of acetaminophen in pregnancy. Dr. Martin Ward-Platt of the Royal College of Paediatrics and Child Health says fever during pregnancy can be harmful to the developing fetus and so acetaminophen is sometimes necessary, according to MNT. But Dr. Ward-Platt says pregnant women should avoid prolonged acetaminophen use and “should always consult with their health care professional before taking any prescription or over-the-counter medicine.”


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Medtronic to Pay $4.4 M to Settle False Claims Act Lawsuit

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Medtronic will pay $4.4 million to settle alleged violations of the False Claims Act, the U.S. Department of Justice said. Medtronic allegedly made false statements involving the sale of medical equipment to the U.S. Department of Defense and the U.S. Department of Veteran Affairs from January 2007 to September 2014. Under United States law, devices sold to the military must be manufactured in the U.S. or by its international trading partners. According to allegations, Medtronic sold equipment manufactured in China and Malaysia and falsely claimed that it originated from the U.S.

“Today’s settlement demonstrates our commitment to ensure that our service members and our veterans receive medical products that are manufactured in the United States and other countries that trade fairly with us,” Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division stated. “The Justice Department will take action to hold medical device companies to the terms of their government contracts.”

“Congress has said that when you sell products to the government, that they must be made in the United States, or in a country that we have a free-trade agreement with,” said Assistant U.S. Attorney Ann Bildtsen, according to Star Tribune. “And companies certify to that … and those certifications need to mean something. This case sends a message that they mean something to the government.”

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