Tamoxifen Drug

Barr Laboratories Inc. must delay introducing its version of AstraZeneca's tamoxifen cancer drug, the Food and Drug Administration said. The maker of generic drugs said it would sue the agency. Barr sells tamoxifen through an agreement with AstraZeneca and had hoped to introduce its formula Aug. 20. The FDA ruling would postpone that to February.

Final results from a large study comparing two drugs for preventing breast cancer challenge the government's claim that raloxifene is safer than the old standby, tamoxifen. In April, the National Cancer Institute, which paid for the $88-million study, said users of raloxifene had fewer uterine cancers and blood clots. But study results released in Atlanta showed that the number of uterine cancer cases differed so little that they could have happened by chance.

Women who take the drug tamoxifen after having cancer removed from one breast may run a higher risk of developing a relatively more dangerous form of cancer in the other breast, according to a new study. The findings contradict previous research and are drawn from the analysis of a small number of patients, which increases the chance they may be a fluke.

The osteoporosis drug raloxifene is as effective as the drug now used to prevent breast cancer in high-risk post-menopausal women, but it has a much lower risk of producing life-threatening uterine cancer and blood clots, according to a new government study comparing the two drugs.

"When I saw her scar for the first time, it looked like a large block of skin, folded over. I would sometimes sit in her room while she got dressed, seeing her place the prosthetic in her bra. Other people would take me places, to school, to gymnastics, but not her. She couldn't do it, she was too sick, especially after the chemo. Her hair fell out. I could hear her retching on the other side of the closed bathroom door, and it made me feel disgusted and revolted.

The National Cancer Institute on Thursday warned against prolonged use of the widely prescribed breast cancer drug tamoxifen, saying that taking it provides little benefit after five years and could be harmful. New studies showed no difference in benefit for women with early breast cancer who stopped after five years on the drug, compared to those who continued longer, the institute said.

Tamoxifen, the first drug touted as a powerful preventive against breast cancer, won a reluctant nod Wednesday from government scientists advising the Food and Drug Administration. But in recommending that the federal agency approve tamoxifen's use for preventing breast cancer in high-risk women, an FDA advisory panel expressed concern that the drug may do less--and for fewer women--than originally hoped.

Women who are at high risk for breast cancer can cut their chances of developing the disease by about half, at least over the short term, by taking the drug tamoxifen. That finding is the main conclusion of the Breast Cancer Prevention Trial, a huge federally funded study that was halted last week when the benefit of the drug became obvious to scientists and officials overseeing it.

Medical researchers will begin the first large-scale breast cancer prevention study for high-risk women using the most widely prescribed cancer drug in the world, the National Cancer Institute announced Wednesday. The trial, expected to involve 16,000 women ages 35 and older and to last from five to eight years, will try to determine whether the drug tamoxifen can reduce the incidence of breast cancer in women at greatest risk of developing the disease.

A noted cancer researcher accused of scientific wrongdoing has been vindicated. "This now permits me to go more full steam," Dr. Bernard Fisher said Thursday. "We have so much data that is just sitting there waiting to be looked at and studied and analyzed." The University of Pittsburgh apologized for removing him as director of the National Surgical Adjuvant Breast and Bowel Project in 1994 after he was accused of being too slow in revealing problems in the study.

While leading cancer researchers are suggesting that 2 million U.S. women are good candidates for tamoxifen to reduce their risk of breast cancer, some doctors and consumer health advocates are questioning the soundness of that advice. Because the drug is known to raise the risk of uterine cancer, stroke and blood clots, they caution that women should wait to begin such therapy until more is known about the medication's long-term effects.

Using tamoxifen in hopes of preventing breast cancer would benefit about 2.4 million women despite the drug's serious side effects, federal researchers reported Tuesday. Tamoxifen is a breast cancer treatment that also can cut by almost half a still-healthy woman's risk of developing the disease. Deciding to use it preventively is a difficult choice, however, because tamoxifen can cause uterine cancer and potentially fatal blood clots.

Barr Laboratories Inc. must delay introducing its version of AstraZeneca's tamoxifen cancer drug, the Food and Drug Administration said. The maker of generic drugs said it would sue the agency. Barr sells tamoxifen through an agreement with AstraZeneca and had hoped to introduce its formula Aug. 20. The FDA ruling would postpone that to February.

For post-menopausal women with estrogen-sensitive breast cancer, chemotherapy may offer no benefit, and a five-year course after surgery of tamoxifen, which blocks the hormone, may be the only treatment needed, a study shows.

An expert panel recommended Sunday that doctors stick with tamoxifen as the time-tested treatment for early-stage breast cancer, despite evidence that newer drugs may do a better job of preventing recurrence. The decision affects the care of about 700,000 women in the U.S. who take tamoxifen to prevent their breast cancer from coming back.

Reducing the risk of recurrent breast cancer in women treated for the disease or keeping the cancer at bay in those who are predisposed have been issues facing doctors for decades. Tamoxifen, prescribed for more than 20 years as a medication to reduce the risk of the disease, is a reliable choice for doctors treating breast cancer patients. And, as a major study three years ago showed, the drug works well stopping cancer before it starts in women at high risk.

Using tamoxifen in hopes of preventing breast cancer would benefit about 2.4 million women despite the drug's serious side effects, federal researchers reported Tuesday. Tamoxifen is a breast cancer treatment that also can cut by almost half a still-healthy woman's risk of developing the disease. Deciding to use it preventively is a difficult choice, however, because tamoxifen can cause uterine cancer and potentially fatal blood clots.

A federal advisory panel recommended Friday that the Food and Drug Administration reject a proposal to undertake a ground-breaking U.S.-Soviet study of 20,000 women to determine whether a hormonal drug can prevent breast cancer. The FDA's Oncology Drugs Advisory Committee agreed that a long-term study should be conducted to determine the effect of the hormonal drug tamoxifen in preventing breast cancer and other cancers in healthy women.

Women who take the drug tamoxifen after having cancer removed from one breast may run a higher risk of developing a relatively more dangerous form of cancer in the other breast, according to a new study. The findings contradict previous research and are drawn from the analysis of a small number of patients, which increases the chance they may be a fluke.

A coalition of consumer groups continued its legal offensive against the pharmaceutical industry Wednesday, asserting in lawsuits that AstraZeneca and Barr Laboratories conspired to inflate the price of the widely used breast cancer drug tamoxifen. The suits, filed in federal court in New York and seven state courts around the country, are part of a broader assault that has turned the drug industry into a magnet for class actions.