Two more deaths after abortion pill reported in US

WASHINGTON, Mar 18 (Reuters) Two more women have died after taking the abortion pill RU-486 but officials do not know if the drug played a role in their deaths, US regulators said.

''At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death,'' the Food and Drug Administration (FDA) said yesterday in an advisory to the public.

Four previously reported deaths were linked to complications from a bacterial infection that developed after the women took the abortion pill, which is sold by privately held Danco Laboratories.

The FDA has not attributed those deaths to the drug but is continuing an investigation.

In the two new cases, it is unknown if the women had bacterial infections, and if so, whether they were infected with the same rare bacterium identified in the earlier deaths. The bacterium is called Clostridium sordelli.

One of the women died several days after taking the abortion pill, an FDA spokeswoman said. The other death occurred weeks after the pill was given.

The FDA said it learned of the deaths from Danco, which issued a statement saying it had little information about them. ''We will continue to carefully review information as it becomes available, and to discuss the situation with (FDA),'' the company said.

RU-486, also known as Mifeprex or mifepristone, is approved for terminating a pregnancy of 49 days or less. Another drug, misoprostol, is given two days later to complete the abortion.

About 560,000 women have taken RU-486 since its approval in September 2000, Danco said.

The drug label warns about the possibility of serious or even fatal infections in rare cases, which also can happen after surgical abortions.

In its alert issued yesterday, the FDA urged physicians and patients to be aware of the possibility of infection following RU-486 and to watch for symptoms such as abdominal pain, nausea, vomiting, diarrhea and weakness with or without fever.

Doctors should consider immediate antibiotic treatment if they suspect an infection, the FDA said. They also should think about ordering blood tests to identify infections in patients without symptoms.

Officials cautioned against unapproved dosing regimens. The four earlier deaths occurred after women were given misoprostol vaginally, rather than orally. The approved regimen calls for oral administration of both drugs.

''The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA,'' the agency said.

Planned Parenthood, which operates health clinics that perform abortions, said it would no longer recommend vaginal administration of misoprostol as an option.

Abortion opponents, who fought for years to keep RU-486 out of the United States, have called for a halt to sales while risks are investigated further.

''How many deaths, investigations and warnings will it take before RU-486 is properly labeled as lethal and removed from the market?'' said Rep. Chris Smith, a New Jersey Republican.

The FDA, with the Centers for Disease Control and Prevention and the National Institutes of Health, is due to hold a meeting in May for scientists and public health experts to discuss infections with Clostridium bacteria.

Last November, FDA officials said they had tested batches of RU-486 and misoprostol and found no evidence they were contaminated with bacteria.

REUTERS VJ RAI0506