J&J COVID-19 Vaccine Possibly Linked With New Type of Blood Clotting

The European Medicines Agency (EMA)’s safety committee said Johnson & Johnson’s (J&J) COVID-19 vaccine might be associated with cases of deep vein blood clotting — such as the leg, arm or groin — and recommended adding the rare side effect to the shot’s product information.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) noted the very rare side effect is separate from the blood clots and low blood platelets previously seen in some recipients of the  J&J and AstraZeneca COVID-19 vaccines, which previously prompted the expert panel to call for adding a warning to the labeling information for those products.

During its late September meeting, the committee also assessed cases of J&J and AstraZeneca shot recipients experiencing immune thrombocytopenia, a bleeding disorder caused by the immune system targeting blood platelets. This side effect was also found to be very rare, but the committee called for adding a warning to both vaccines’ product information.

In other work, PRAC launched a review of nomegestrol- and chlormadinone-containing medicines for the risk of meningioma, a tumor that grows from the membrane surrounding the brain and spinal cord. Though such tumors are usually noncancerous, their location on the body mean they could cause serious problems for patients.

Drugs containing nomegestrol or chormadine are used to treat a range of gynecological conditions, such as menstrual disorders, uterine bleeding or endometriosis, and are also used in hormone replacement therapy and birth control.

French drug regulators requested the review after receiving data from two epidemiological studies of women taking medications with these active substances.

PRAC said it will examine the data and recommend whether EU marking authorizations for the drugs should be withdrawn. ― Jason Scott