EMEA recommendation on use of angiotensin II receptor antagonists during pregnancy

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has recommended that the product information of all centrally authorised angiotensin II receptor antagonists be harmonised, regarding their use during pregnancy. Following a review of the safety of these medicines during pregnancy, the EMEA's Committee for Medicinal Products for Human Use (CHMP), at its April 2008 meeting, recommended that the product information should state that the use of angiotensin II receptor antagonists should be avoided in the first three months of pregnancy.

The CHMP also confirmed that angiotensin II receptor antagonists must not be used during the second and the third trimester of pregnancy and that the contraindication already in place should therefore be maintained.

Angiotensin II receptor antagonists are used in the treatment of patients with essential hypertension (high blood pressure that has no identifiable cause).

The CHMP conclusions stem from a safety review conducted by the EMEA's Pharmacovigilance Working Party. This review included also a large number of non-centrally authorised medicines. Implementation of the recommendations for non-centrally authorised medicines will follow through the appropriate national procedures.

For more information, visit:
http://www.emea.europa.eu

Most Popular Now

Pfizer and BioNTech complete submission to Europea…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted biva...

AstraZeneca to acquire TeneoTwo and its clinical-s…

AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluatio...

Lilly will supply an additional 150,000 doses of b…

Eli Lilly and Company (NYSE: LLY) announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately...

Bayer to sell men's health product Nebido™ to Grün…

Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer's men's health product Nebido™ (testosterone undecanoate), for a purchase price ...

Demonstration of a potent, universal coronavirus m…

The SARS-CoV-2 that causes COVID-19 has killed 6.3 million people worldwide since 2019, painfully highlighting the vulnerability of humanity to novel coronaviruses. Re...

Vaccine protection against COVID-19 short-lived, b…

Since COVID-19 vaccines first became available to protect against infection and severe illness, there has been much uncertainty about how long the protection lasts, and w...

SARS-CoV-2 hijacks nanotubes between neurons to in…

COVID-19 often leads to neurological symptoms, such as a loss of taste or smell, or cognitive impairments (including memory loss and concentration difficulties), both dur...

Anti-inflammatory compound shows potential in trea…

An anti-inflammatory compound may have the potential to treat systemic inflammation and brain injury in patients with severe COVID-19 and significantly reduce their chanc...

Pfizer and BioNTech advance COVID-19 vaccine strat…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to...

Vaccine-induced immune response to omicron wanes s…

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substan...

Scientists develop new biomimetic formulation for …

Glioblastoma multiforme (GBM) is an aggressive brain cancer with a poor prognosis and few treatment options. New and effective approaches for GBM treatment are therefore ...

New needle-free nasal vaccine shows promise for CO…

New research shows that a needle-free mucosal bacteriophage (phage) T4-based COVID-19 vaccine is effective against SARS-CoV-2 infection. The findings were published in mB...