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Sanofi has been ordered by a French court to pay more than 400,000 euros ($416,440) in damages to a family whose child was diagnosed with a form of autism caused by epilepsy drug valproate, sold under the name Depakine in France. The family says the drugmaker failed to inform consumers about known side effects.
The court concluded the drugmaker must have known about the risk that the drug could cause malformations and “neuro-behavioral disorders” in children if taken by pregnant women, Reuters reports. The risk should have been mentioned in the drug's attached leaflet, the court found. It’s the first ruling in France to make a link between the drug and autism in an individual patient's case.
Sanofi said it will appeal the decision. The company says it made several demands of the country's health authority to modify the information documents and leaflet. However, in its decision the court “did not take into consideration the refusal of the health authorities at the time to take into account the requested changes,” Sanofi said in an emailed statement.
“The effectiveness of sodium valproate—which is on the list of essential medicines of the World Health Organization—has never been called into question,” a Sanofi spokesperson said. “Moreover, the Court emphasizes that the benefit/risk ratio is positive. This drug remains essential for millions of patients with epilepsy.”
Links:
https://www.fiercepharma.com/pharma/sanofi-ordered-french-court-compensate-epilepsy-drug-side-effects-report
https://bmjopen.bmj.com/content/bmjopen/12/4/e058312.full.pdf
https://www.theguardian.com/society/2017/sep/26/sodium-valproate-birth-defect-risks-known-40-years-ago-campaigners
Warnings to young women who might become pregnant that the epilepsy drug sodium valproate could cause birth defects and developmental problems in their babies could have been made public more than 40 years ago, according to campaigners.
“These warnings could have and should have been given in 1974,” said Catherine Cox from the Fetal Anti-Convulsant Syndrome Association at a public hearing of the European Medicines Agency, which is conducting a risk assessment of the drug. “However, there was a deliberate decision not to publish them.”
Don't Tell: A New Way To Market A Drug
The period after Christmas is traditionally the time of the year when many try to reduce weight, using whatever means available to do so. Many look to so called “Natural Products”, and in the market there are weight reduction products which make claims that are not regulated. It is also well known that active prescription only drugs have been sneaked into many such natural products in an attempt to make a quick buck. This of course involves some drug firms manufacturing the pharmaceutical ingredients in the first place.
According to the FDA, it looks like Sanofi-Aventis (a major European drug company) has secretly introduced a controversial diet drug Zimulti into a diet pill called Phyto Shape. In fact, more than 25 weight loss products against which the FDA warned consumers were found to contain undeclared prescription-strength medicines that could endanger people’s health.
The picture is now becoming sinister, like in a John Grisham novel.
The obesity drug Zimulti was denied approval in the U.S. and in October was pulled off the market in Europe out of concerns over psychiatric side effects, including depression. This drug belongs to a group called rimonabants, and has been sold in Europe under the name of Acomplia.
The FDA says in a Q&A that another powerful drug, Sibutramine, a controlled substance that is the active ingredient in Abbott’s approved prescription weight-loss pill Meridia, has been found in products such as 24 Hours Diet and ProSlim Plus. Some of these diet aids contain more than three times the recommended daily dosage of Sibutramine, putting people at risk of harmful side effects such as increased blood pressure, tachycardia, palpitations, and seizure.
There appears to be a new and serious way to market a drug: DON’T TELL.
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