Health

The US Food and Drug Administration (FDA) is warning doctors and patients that an anti-seizure drug, Lamictal, can cause rare inflammation of the brain and spinal cord. The FDA said last Thursday it was working with the British drugmaker, GlaxoSmithKline PLC, to add new warnings and labelling information to Lamictal.

The FDA said it has received reports of 40 cases of aseptic meningitis between 1994, when Lamictal was approved, and last November. Thirty-five patients needed to be hospitalised, the agency said in a statement. The symptoms usually emerged within the first month and a half of treatment.

GlaxoSmithKline said in a statement it will add language about the risk to a medication guide distributed to patients. According to the company, aseptic meningitis is a "very rarely reported event."

Aseptic meningitis is a dangerous inflammation of the brain and spinal cord that can cause headache, fever, chills and vomiting. The problem can be caused by viruses, toxins and certain medications. Treatment for the illness, which usually resolves itself in two weeks, generally involves pain medications. Lamictal is part of the anti-seizure family of medications and is also approved by the FDA to treat manic depression.

- Source: The Associated Press

Emergency contraception approved

The US Food and Drug Administration last week approved ella (ulipristal acetate) tablets for emergency contraception. The prescrip-tion-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne. An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-centre, open-label, single-arm trial conducted in the United States; the other was a randomised, multi-centre, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.

- Source: The US Food and Drug Administration