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Women seek answers on drugs suspected side effects

Women battle for answers to post-drug health problems

by Kay LazarBoston Herald
August 23rd, 1999

Second in a two-part series.

Hundreds of women nationwide, with nowhere else to turn, are forging a campaign against a drug they believe has ruined their health and their lives.

The women charge that Lupron, a drug with few tests for long-term side effects, has wracked their bones, robbed their memories and damaged their vision.

"My knees tremble a lot and get very weak, and I have to use a cane now to go up and down the stairs," said Kimberly Savino, 17, of Easton, who was prescribed Lupron last year for a gynecological problem.

Before taking the drug, Savino said she often rode horses and jogged. Today, three months after stopping Lupron, the teenager has trouble even walking and has been diagnosed with a degenerative arthritis, which usually develops over many years.

Her mother is worried - and suspects Kimberly's strange bone problems were triggered by Lupron.

"It's very hard to see her, all of a sudden, moving around like an old lady with a cane," said Susan Savino. "Now we don't know if she is going to end up in a wheelchair. This shouldn't be happening to someone who is 17."

Deerfield, Ill.-based TAP Pharmaceuticals, the giant drug company that makes Lupron, insists its product is safe. And federal regulators say no studies have linked Lupron to any of the long-term debilitating side effects a growing number of women are reporting.

Undaunted, many of the women - from Massachusetts and California to Canada and Florida - have taken to the Internet (www.delphi.com-afterlupron), organizing a petition they hope will convince federal regulators to take a closer look. At the very least, the women say, they want information added to the drug's packaging, alerting consumers to potential long-term side effects.

The Herald interviewed a dozen of the women, including Kimberly Bradford of Apopka, Fla.

"I'm hoping we can show somebody who has influence that there are a lot of women who this has happened to, and to get them to take a look at what has happened to us," she said.

Bradford, 31, took Lupron seven years ago for endometriosis, a common gynecological disease. Today, she said, she still struggles with vision problems, dizziness and joint and muscle pain that started while she was on the drug.

Lupron is a potent hormone that was first approved by the federal Food and Drug Administration in 1985 for men with advanced prostate cancer who had few treatment options. The drug more recently has been used widely by doctors to treat women for various gynecological problems, including infertility.

To date, the FDA has logged 6,272 complaints filed for suspected adverse side effects from Lupron - 553 of those within the past 20 months.

"You don't want to lose sight of the fact that some patients have a condition where this might be one of the best treatments available to them," said the FDA's Dr. Marianne Mann, deputy director of the division of reproductive and urologic drug products.

Indeed, the International Endometriosis Association, a nonprofit organization with 10,000 members, takes the position that Lupron should be available for women to make their own choices, but warns women the drug may have potential side effects.

Lupron's packaging, in highly technical terms, does list several potential, serious side effects, including memory disorders and depression, but does not say that any of them - except for a "small loss" of bone mass - may be irreversible.

Medical experts say loss of bone mass, typical in older, post-menopausal women, can lead to a variety of problems, including fractures and joint problems.

Many of the young women with long-term problems they attribute to Lupron are reporting a gnawing pain in their bones, and a recent study raises questions about that issue.

In a report submitted by TAP Pharmaceuticals to the FDA in April 1998, researchers wrote that they were "concerned" because more than one-third of the women they studied who took Lupron did not "demonstrate either partial reversibility" or "a trend toward return" of bone mass in the six months after they stopped taking the drug. Further, the researchers noted some women lost as much as 7.3 percent of their bone density during treatment - more than twice the amount the drug's packaging lists in its warnings.

The researchers concluded, "A more complete assessment of the effects of Lupron on (bone density) can only be made with longer term follow-up of these patients."

In an interview, the drug's maker, TAP Pharmaceuticals, said its studies show Lupron is safe.

"We continue to monitor reported side effects through post-marketing surveillance and continuing research studies," said TAP's Kim Modory.

But in Hyde Park, Sister Regina Rowan is worried.

Rowan, who has a master's degree in clinical microbiology, is executive director of the office for responsible investment, for the Medical Mission Sisters.

Rowan is troubled by the reports of Lupron's growing use by doctors in infertility treatments.

The FDA has not approved Lupron for infertility, but it allows drugs the agency has approved for one use to be prescribed for any other use.

"There are many side effects with this drug," Rowan said. "It indicates that this drug has some toxicology in it, and that it should not be used for this purpose."

Rowan's mission buys stock in companies and then brings practices by those companies it considers questionable to shareholder actions. The mission is now focusing on Lupron's manufacturer, TAP Pharmaceuticals, which is a joint venture of Abbott Laboratories and Takeda Chemical Industries, Japan's largest drug company. Rowan's mission owns stock in Abbott.

"We will be writing to the chairman at Abbott and asking questions about Lupron," Rowan said. "I will say that I am concerned and ask for a meeting."

That's the most promising news Lynne Millican has heard in a long time. Millican, 42, a registered nurse who lives in West Roxbury, said she is still battling bone pain and memory loss she said started 10 years ago when she took Lupron.

"Something happened to my body," Millican said. "I want answers."



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