By Peter C. Gøtzsche at Brownstone dot org.

As a young doctor, I joked about a general warning that can still be seen in Danish package inserts for drugs: "Caution is advised during pregnancy." What does that mean? If you take a pill, it is too late to be cautious, and if you don't take it, you don't need to be cautious because you will be totally safe. My joke was that caution meant placing the pill between the legs instead of swallowing it, which would also make it more difficult to become pregnant.

The authorities passed the buck. If your child is malformed, they can say that they did warn you.

Official statements that antidepressants are safe to take during pregnancy should be distrusted. No drug is safe. If drugs were safe, they would not be the leading cause of death, ahead of cardiovascular diseases and cancer. In this article, I shall explain why it is wrong to recommend or take antidepressants during pregnancy.

The Role of Serotonin in the Body

SSRIs stands for Selective Serotonin Reuptake Inhibitors, which is a misnomer. They are not selective at all. They have multiple effects throughout the body and are not directed against any chemical abnormality. People do not become depressed because they have too little serotonin in the body but mainly because they live depressing lives.

Serotonin plays a very important role for many processes in the body, also in many primitive organisms. It is usually a very bad idea to change the blood level of a chemical that has proved so useful during evolution.

Foetal development is a delicate process that can easily go wrong, which is why we tell pregnant women to avoid alcohol. A priori, we would expect any substance that affects serotonin levels to be harmful because serotonin is essential for foetal development. This is basic biology, but we live in a world dominated by financial interests, which is why many pregnant women take antidepressants during pregnancy.

How a Drug Company Fooled the Drug Regulators

The first SSRI approved for use in children was fluoxetine from Eli Lilly. It should never have been approved. When psychiatrist David Healy and I reviewed the confidential internal study reports for the two trials that led to approval of fluoxetine for children with depression, we found that fluoxetine is unsafe and ineffective. In the first trial, the investigators had omitted two suicide attempts on fluoxetine in their published paper, and many of the 48 children on the drug experienced restlessness and had nightmares, which increase the risk of suicide and violence.

In the other trial, one child was severely harmed for every 10 children treated with fluoxetine. Fluoxetine increased the QTc interval on the ECG (P = 0.02), which increases the risk of sudden death, increased serum cholesterol, and was an effective growth inhibitor, reducing the increases in height and weight over just 19 weeks by 1.0 cm and 1.1 kg, respectively (P = 0.008 for both).

The public does not have access to animal experiments with drugs because the drug companies know it would be bad for business if people saw the data. When I got access to Merck's animal studies for their HPV vaccine Gardasil in a US lawsuit where I was an expert witness, I saw that the data supported what the patients had reported: Gardasil can cause serious neurological harms and the vaccine adjuvant is also harmful. However, drug regulators all over the world have declared that both the adjuvant and Gardasil are safe.

The European Medicines Agency (EMA) had serious concerns about approving fluoxetine for use in children, which is clear in an 86-page document about animal studies from August 2005 that is nowhere to be found on the Internet: "Prozac Paediatric Indication. Arbitration Procedure No: EMEA/H/A-6(12)/671. Lilly Response to Questions from EMEA in Document EMEA/CHMP/175191/05". I have uploaded this document in the public interest. It illustrates the extent to which drug companies are willing to bend the truth for an econo...