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Antidepressants Linked Autism : Gilbert Daily Science

After adjusting for maternal confounders, the use of any antidepressant by mothers in the second and/or third trimester of pregnancy was associated with autism spectrum disorder (ASD) at a hazard ratio of 1.87 (95% CI 1.15-3.04) relative to pregnancies with no maternal antidepressant use, according to Takoua Boukhris, MSc, of the University of Montréal, and colleagues.

When the analysis was restricted to SSRI antidepressants, Boukhris and colleagues calculated an adjusted hazard ratio of 2.17 (95% CI 1.20-3.93), they reported in JAMA Pediatrics.

There was no increased risk for antidepressants overall or for SSRIs during the first trimester or in the year before pregnancy.

Scientists don’t fully understand the causes of autism, though many suspect a mix of genetics and environmental factors. Trying to gauge the role of medications during pregnancy is difficult—experts cautioned that there isn’t any clear evidence that allowing depression to continue untreated is safer than taking antidepressants.

“There’s no good study design to tease those apart,” said Siobhan Dolan, a professor of clinical obstetrics and gynecology at the Albert Einstein College of Medicine who isn’t involved in the study. “It’s not, ‘medication is bad and being a depressed mother is a perfectly fine outcome.’ There’s an impact of having depression and trying to raise a child.”

Bryan H. King, a psychiatrist at Seattle Children’s Hospital, wrote in an editorial accompanying the study that further research is unlikely to reveal “a straight line” between the use of antidepressants during pregnancy and autism. Also, the Quebec study wasn’t a randomized control trial, the gold standard for establishing the effects of a particular drug. Instead, it looked at medical records retrospectively, which means that unforeseen factors could account for any link between antidepressant use and autism.

The analysis covered 145,456 singleton births in the province of Quèbec over a 12-year period, in which 31 were born to women using antidepressants during the second/third trimesters. Of these, SSRIs were involved in 22 of the pregnancies.

Exposure to more than one class of antidepressants was associated with the most substantial increased risk of ASD for five infants who were exposed (adjusted HR 4.37, 95% CI 1.44-13.32). But there was no increased risk associated with other classes of antidepressants (such as SNRIs, MAOIs, and tricyclic antidepressants).

Overall, there were 1,054 children with “at least one diagnosis” of ASD (0.72% of the sample). Max Wiznitzer, MD, of University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, told MedPage Today that even if the risk of ASD was doubled with SSRI use, there would be approximately a 2% chance that a child would have autism compared to approximately a 1% chance.

“That’s still a 98% chance that you’re not going to get autism,” said Wiznitzer, who was not involved with the study. “The media will say ‘The risk is two-fold, oh my God!’ But I think what we have to say is the absolute numbers are much more important.”

Other studies have been published on this subject, including a recent study with a larger sample size that found no association between ASD and use of SSRIs during pregnancy.

Causation Not Proven

Eva Pressman, MD, of the University of Rochester Medical Center in Rochester, N.Y., said that while the new study found a stronger association later in pregnancy, perhaps the patients that were unable to come off their antidepressants in the early part of their pregnancy had more severe disease.

“It’s very hard to combine the two studies together and know what’s going on and that’s often the trouble with epidemiologic data,” she told MedPage Today. “I think it does make it clear that we need more studies and we need the sorts of studies that will actually get at the underlying biology.”

Secondary analyses of children of mothers with a history of maternal depression also found an increased risk associated with SSRIs during the second and/or third trimester for 29 exposed infants (adjusted HR 1.75, 95% CI 1.03-2.97).

Sensitivity analyses examining only children with ASD who had their diagnosis confirmed by a psychiatrist or neurologist did have an increased risk of ASD, but the authors noted the risk was not statistically significant.

Wiznitzer commented that there was no information about how children were diagnosed, and that well-known depression rating scales have a high false positive rate.

He added that if there was no statistically significant difference when specialists diagnosed ASD, that might say something about ASD diagnosed by other health professionals.

“If the specialists couldn’t find a statistical difference, what do we make of this larger database with other people who have less expertise — were they actually making diagnoses correctly or were they over-labeling?” Wiznitzer said. “Kids of parents with depression and anxiety are at higher risk of presenting with different types of behaviors that could be mislabeled or misconstrued as ASD.”

An accompanying editorial by Bryan King, MD, of the University of Washington in Seattle, suggested that the potential increase in ASD could come from diagnostic substitution — a phenomenon that has also been proposed by other recent studies.

“Might an increase in diagnoses of ASD be mediated by an increase in the frequency of intellectual disability or some other neurodevelopmental risk factor?” he wrote. “An increase in one diagnosis might actually be regarded as positive if it resulted in a decrease of a more severe condition.”

Study Details and Limitations

Boukhris’ team examined data from the Quèbec Pregnancy/Children Cohort from 1998 to 2009. Overall, 4,724 infants were exposed to antidepressants in utero (3.2%), with 4,200 infants exposed in the first trimester (88.9%) and 2,532 exposed in the second and/or third trimester (53.6%). The mean age of autism diagnosis was 4.6 years (SD 2.2), with a median of 4.0 years. The mean age of children at the end of follow-up was 6.2 years (3.2) with a median of 7.0 years. Boys with ASD outnumbered girls by a 4:1 ratio.

King commented on the mean age of diagnosis, considering that ASD cannot be reliably diagnosed at birth and in early infancy.

“When considering the true prevalence of ASD, one might want to exclude children younger than 2 years from the denominator because they have not yet had a chance to manifest symptoms of ASD or be evaluated for it,” he wrote.

Other limitations acknowledged by the authors are the study’s use of prescription-filling data for antidepressants, which may not reflect actual use. They also noted that they lacked data on maternal lifestyle, such as smoking or body mass index, as noted that the cohort was predominantly of lower socioeconomic status, which may limit the generalizability of the findings.

Pressman urged caution when interpreting the study, saying that stopping SSRIs would not be beneficial for pregnant women who are severely disabled by depression or for whom other medications do not work.

“I think it’s really important that we don’t take this study and say ‘everybody should come off of their SSRIs during pregnancy,’ because you have to be very careful with a sweeping recommendation like that,” she said. “It’s really hard to change the practice of medicine because of what you found in 31 infants.”

Wiznitzer said that the authors themselves admitted that they didn’t consider all the variables when examining the risk for ASD and that those variables are important.

“It’s a good study with a large population, but all it is is number crunching,” he concluded. “The benefits of treating maternal depression far outweigh any small risk [to offspring] that might be present.”

Courtesy of

Lawsuit Blames Defective Trinity Guardrail Amputated Man's Leg

Watch James Morris discuss Trinity Guardrail Lawsuit

ABC Team 10 News has uncovered a lawsuit filed in San Diego County Superior Court that claims a man was badly injured when he was impaled by a guardrail in San Marcos.

The suit, filed by 26-year old Andy Weidemann, claims the guardrail was defective and the manufacturer, the City of San Marcos and other government entities knew or should have known it could cause injuries.

Read the Lawsuit : Andrew Weidemann -v- Trinity Highway Products, LLC (pdf)

Weidemann spent most of his life involved in sports. He played football all four years of high school. He played softball in an "old man's" league. He went water-skiing, snowboarding, anything to enjoy outdoor exercise. That was until last summer when Weidemann was involved in a horrific crash.

It happened on Twin Oaks Valley Road, near Cal State San Marcos. Weidemann recently graduated and had been out celebrating with friends. It was 2 a.m. on June 22, 2015.

"I woke up and I was down an embankment and I looked down and I saw that my legs were pretty much mutilated. My right leg, the calf, was pretty much hanging off the bone and there was a lot of blood," said Weidemann.

A length of guardrail sliced through the front end of his car, and through Weidemann's leg.

"I was really scared...really, really scared. I was fearing for my life because I saw how much blood I was losing," Weidemann recalled.

His mangled car was in a ravine nearly 300 feet from the road. Weidemann's cell phone lay somewhere in the bushes. He wondered whether anyone would find him.

A half hour later, fire crews arrived. "They were calming me down," Weidemann said. "They were telling me things were going to be all right, and they were there with me... I was still afraid. I knew it was a severe accident and the injuries were bad."

They used the jaws of life to cut Weidemann from his crushed car and rushed him to the hospital.

"I was in the operating room and I remember the doctor telling me that 'we have to amputate your leg. There's nothing we can do.'" Weidemann was devastated. "The facts hit me. I won't be walking ever again."

After six surgeries, Weidemann believes he will walk again. A metal plate and several pins patched his left leg back together. It is a patchwork of scars, and there is pain, but Weidemann has begun to slowly put weight on that leg.

The next step is a prosthesis for his right leg.

Weidemann isn't talking about the lawsuit filed by his attorney, Jim Morris. Morris is part of the Texas-based law firm that's filed a total of six lawsuits against the maker of the guardrail, Trinity Industries.

The lawsuit filed on behalf of Weidemann claims Trinity, the City of San Marcos, San Diego County, and the State of California were negligent for installing the guardrail, saying they "knew or should have known there was a problem with their unilateral, unapproved modification of its guardrail and end terminal."

The lawsuit specifically mentions the ET Plus guardrail end-terminal, which in 2015 was the subject of a federal lawsuit. Trinity was ordered to pay more than $600 million for making false statements to the government about modifications to the ET Plus over a decade ago.

Although there have been several claims that the modified ET Plus maims or kills people instead of protecting them in crashes, to date, no court has ruled Trinity was negligent in a crash case.

A Team 10 investigation in the days after Weidemann's crash revealed the end terminal was a Trinity product, but was not an ET Plus.

We asked Morris if that would negate the claims in Weidemann's lawsuit. "They can deny that it's an ET Plus and discovery will shine a light on whether or not they're correct about that or not," he said. " What we know is that the guardrail behaved like an ET Plus as modified, because if you've seen the photographs of Mr. Weidemann's car, clearly the guardrail is going straight through his cabin, and that's what amputated his leg."

A spokesman for Trinity disagreed. Jeff Eller questioned whether the lawsuit is viable, saying it won't stand up in court from a factual standpoint.

“If it's not an ET Plus, then his lawsuit doesn’t have merit. It's either an ET Plus or It’s not. At this point, we have reasonable evidence to say that it does not appear to be an ET Plus, and we’re going to be making that fact known to the court at the appropriate time," said Eller.

Eller called the ET Plus "the most crash-tested end terminal system on the roads today. It has an unbroken chain of approval and eligibility by the federal government."

Safety advocate Josh Harman, who is a critic of the modified ET Plus, visited the crash site with Team 10 just days after the crash. He said the ET Plus wasn't in use at the site when Weidemann crashed. He said the type of end unit installed by the City of San Marcos was also dangerous because it had no break-away capabilities.

Team 10 contacted the City of San Marcos for a response to the lawsuit. A spokesperson said a statement would be made available, but that didn't happen. Both a spokesperson for San Diego County and for CalTrans declined to comment on the lawsuit.

The collision report filed by a San Diego County Sheriff's Deputy said Weidemann was driving 90 miles an hour just before the crash. After the crash, he was tested for intoxication. Weidemann tested over the legal limit, and was charged with DUI. A spokesman from the San Diego County District Attorney's office said Weidemann pleaded guilty to a misdemeanor count of DUI and was sentenced to five years probation.

Weidemann is now studying to become a substitute teacher while he recovers from the crash. He'd like to be a coach or a P.E. teacher.

Weidemann said he now appreciates the little things he once took for granted like walking, or being able to go to the bathroom unassisted. His advice for others who find themselves dealing with serious injuries is know that you're not alone. Reach out to others with the same disabilities for advice and comfort, as he has.

Courtesy of KGTV San Diego : ABC 10 News

James Morris Discusses Johnson & Johnson $72 Million Cancer Lawsuit

A jury has ordered Johnson & Johnson to pay $72 million in damages to the family of a woman who claimed she developed cancer after using the company’s baby powder.

Jacqueline Fox, of Tarrant, Alabama, was among 65 women who sued the company in June 2014.

The women claimed they had developed ovarian cancer after using products containing talcum powder.

They alleged their diseases were “a direct and proximate result of the unreasonably dangerous and defective nature of talcum powder,” according to a copy of the lawsuit.

The products named in the lawsuit were Johnson & Johnson’s Baby Powder and Shower to Shower, a feminine hygiene product.

The women claimed that the company knew that talcum powder had been suggested as a link to ovarian cancer as early as 1971, but that the concerns were ignored.

“[Johnson & Johnson] procured and disseminated false, misleading, and biased information regarding the safety of the products to the public and used influence over governmental and regulatory bodies regarding talc,” the lawsuit states.

The case was tried in St. Louis County Circuit Court in Missouri, after which jurors found the company guilty of negligence, conspiracy, and fraud, according to a statement from the Fox family’s law firm Beasley Allen.

Ted G. Meadows, a principal at the firm, said in the statement Fox was an “incredible lady whose life was cut far too short by the callous decisions by the bosses at Johnson and Johnson.”

“Inside J&J folks have known for decades, literally decades, that the talc contained in its products could cause cancer,” he said. “Instead of warning customers, J&J executives made the deliberate decision to hide the risk and keep on selling.”

The mom had used Johnson & Johnson’s products for decades for feminine hygiene when she was diagnosed, according to the law firm.

Her son, Marvin Salter, posted a tribute to his mother on Facebook before the verdict was announced.

“My dear sweet mom,” he wrote. “The pain of [losing] you is so hard but I’m thankful your suffering is over. Forever your prince.”

The case is just one of many filed against the company over the ovarian cancer claims.

About 1,000 lawsuits have been filed against Johnson & Johnson over the cancer claims in Missouri, and 200 have been filed in New Jersey, Reuters reported.

James A. Morris Jr., a Los Angeles-based product liability attorney, told BuzzFeed News he thinks the recent verdict will open the floodgates for multiple cases against Johnson & Johnson over similar claims.

“It’s a huge verdict in what could become a very large mass tort,” he said.

Morris hopes cases like these will “hopefully educate the public” of the alleged risks of using talcum powder, and help those who feel they were affected get compensated, he added.

Studies examining whether talcum powder can lead to an increase in ovarian cancer in women have reported mixed results, according to the American Cancer Society.

“Many studies in women have looked at the possible link between talcum powder and cancer of the ovary,” the organization says on its website. “Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase.”

“Many studies in women have looked at the possible link between talcum powder and cancer of the ovary,” the organization says on its website. “Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase.”

“Many studies in women have looked at the possible link between talcum powder and cancer of the ovary,” the organization says on its website. “Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase.”

“Many studies in women have looked at the possible link between talcum powder and cancer of the ovary,” the organization says on its website. “Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase.”

Courtesy of

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