- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Sanofi charged with Manslaughter over birth defects linked to its epilepsy drug Depakine
The charges relate to the drug valproate, marketed as Depakine among other trade names, which studies say has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant.
Paris: French prosecutors have indicted pharma giant Sanofi for manslaughter over birth defects linked to an epilepsy drug, the company said Monday, in a long-running case that has also seen it charged with fraud.
The charges relate to the drug valproate, marketed as Depakine among other trade names, which studies say has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant.
On the market since 1967, the drug is used to treat epilepsy, migraines and bipolar disorder.
But research found that when pregnant women took the drug, their children had an elevated risk -- between 10 to 40 per cent -- of congenital malformations, autism and learning difficulties.
Sanofi is facing separate charges of aggravated fraud and unintentionally causing injury in 42 cases filed by families, but insists it had warned health authorities of the drug's risks already in the 1980s.
On Monday, the company confirmed a report in Le Monde newspaper that prosecutors have now also charged it with manslaughter.
But in a statement sent to AFP it insisted it had "fulfilled its obligation" of providing information on the drug and its side-effects, and said it "contests the validity of these proceedings."
Sanofi said it has filed a legal challenge to the indictment.
Under the French legal system, charges do not automatically result in a trial as prosecutors can decide not to proceed based on a lack of evidence.
Last month, a French court ordered the state to pay thousands of euros in damages over the scandal, saying officials should have ensured the drug was not taken by pregnant women.
The court found that health officials knew about the risk of birth defects from Depakine already in 1983, and of learning disabilities and autism from 2004.
Another 500 complaints have been lodged with France's national compensation agency for medical accidents, which has already proposed a 6.5-million-euro ($7.6-million) package for Depakine victims.
Sanofi, a France-based multinational, is working on a candidate vaccine against the novel coronavirus with Britain's GSK, for which it will receive up to $2.1 billion from the US government.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Next Story