European Medicines Agency started reviewing HPV vaccines safety

EMA confirmed evidence does not support that HPV vaccines cause CRPS or POTS… but the Nordic Cochrane Center said their report is flawed…

image of hpv-vaccine
Concerned by reports of serious adverse effects in young women receiving human papillomavirus (HPV) vaccines, the European Medicines Agency started a safety review. Three HPV vaccines are currently licensed in Europe: Gardasil/Silgard, Gardasil 9, and Cervarix, all of which are approved in the U.S. as well.

July 2015

The European Medicines Agency (EMA) started a review of HPV vaccines to further clarify aspects of their safety profile.

The review looked at available data with a focus on rare reports of two conditions:

  • complex regional pain syndrome (CRPS)
    a chronic pain condition affecting the limbs,
  • postural orthostatic tachycardia syndrome (POTS)
    a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness.

In its review the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) considered the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee decided whether to recommend any changes to product information to better inform patients and healthcare professionals.

November 2015

EMA concluded this review : HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS.

Summer 2016

An official complaint has been filed by the Nordic Cochrane Center against the European Medicines Agency (EMA) over its handling of safety issues concerning human papillomavirus (HPV) vaccines.

In the complaint, which runs to 19 pages, the Nordic group says that the official EMA report is flawed.

  • Complaint to the European Medicines Agency (EMA) over maladministration at the EM, Nordic Cochrane Centre, 26 May 2016.
  • Complaint Filed Over EMA’s Handling of HPV Vaccine Safety Issues, Medscape Medical News, July 05, 2016.

There was NO Benefit with the Use of Diethylstilbestrol in preventing Miscarriages

More the opposite: DES-exposure in utero led to increased rate of miscarriage and preterm birth

Abstract

image of snake-oil-reps
Diethylstilbestrol usage is now obsolete in modern obstetrics practice. The review is historical to buttress the need for adequate and rigorous research into the use of drugs in pregnancy and ensure that they do more good than harm before being introduced for consumption.

Oestrogen supplementation, mainly diethylstilbestrol, for preventing miscarriages and other adverse pregnancy outcomes

BACKGROUND:
Laboratory evidence in the 1940s demonstrated a positive role of placental hormones in the continuation of pregnancy. It was suggested that diethylstilbestrol (DES) was the oestrogen of choice for prevention of miscarriages. Observational studies were carried out with apparently positive results, on which clinical practice was based. This led to a worldwide usage of diethylstilbestrol despite controlled studies with contrary findings.

OBJECTIVES:
To determine the effects of antenatal administration of oestrogens, mainly diethylstilbestrol, on high risk and unselected pregnancy as regards miscarriages and other outcomes.

SEARCH STRATEGY:
We searched the Pregnancy and Childbirth Group Specialised Register of controlled trials in November 2002.

SELECTION CRITERIA:
Randomised and quasi-randomised trials were included.

DATA COLLECTION AND ANALYSIS:
Both reviewers extracted data from the studies identified that met the selection criteria, and the data were analysed using the RevMan software.

MAIN RESULTS:
Miscarriage, preterm labour, low birthweight and stillbirth or neonatal death were not positively influenced by the intervention (diethylstilbestrol) as compared to the control group. Diethylstilbestrol in utero exposure led to increased rate of miscarriage and preterm birth. There was also an increase in the numbers of babies weighing less than 2500 grams. The maternal outcome in terms of pre-eclampsia was not influenced. Exposed female offsprings have a non-significant trend towards more cancer of the genital tract and cancer other than of the genital tract. Primary infertility, adenosis of the vagina/cervix in female offsprings, and testicular abnormality in male offsprings were significantly higher in those exposed to diethylstilbestrol before birth.

REVIEWER’S CONCLUSIONS:
There was no benefit with the use of diethylstilbestrol in preventing miscarriages. Both short and long-term adverse outcomes in exposed offsprings were demonstration of the harm that this intervention caused women and their offspring during its usage.

Sources
  • NCBI, Oestrogen supplementation, mainly diethylstilbestrol, for preventing miscarriages and other adverse pregnancy outcomes, PMID: 12918007, 2003;(3):CD004353.
  • The Cochrane Library, Full Article, DOI: 10.1002/14651858.CD004353, 21 JUL 2003 – PDF
More DES DiEthylStilbestrol Resources