Bextra: Two Women's Stories

Sueanne Gatto from Port Charlotte, Florida was prescribed Bextra when she broke her shoulder and again for carpal tunnel syndrome. All together, she was taking Bextra for more than two years, until she suffered a stroke in April, 2005. She is 50 years old.

"I woke up one morning and couldn't see, I couldn't even find the phone to call anyone," says Gatto. "My husband came home for lunch and immediately took me to emergency. They did some tests, my blood pressure was going crazy and after repeated CAT scans, they found that areas in the occipital lobe of my brain were damaged." Gatto was terrified. And she has no family history of high blood pressure or heart problems.

The tests couldn't determine the cause of her stroke but she stopped taking Bextra. "Today I feel OK but I can't work. I can take care of the house now but it took some time." Her quality of life has greatly decreased. "I can't go outside by myself too much, and I can no longer drive."

Regina Woolley's doctor gave her free samples of Bextra for arthritis three years ago. "I took them for a few months, then on Dec 3, 2002 I had a heart attack at home and I didn't know what was going on," she says. She had severe chest and back pain but because of her chronic arthritis, she didn't realize that it was a heart attack.

"When my husband came home, he drove me to the hospital. They took me into ER and I had another heart attack while getting an EKG, so then I had an angiogram and had a stent inserted," says Woolley. She had a blockage in the main right artery of her heart. "I was scared to death. They told me that I would have died if I hadn't come to the hospital right away."

This past June she had another heart attack. "I felt bad again -- my heart was pounding so I went straight to the hospital and I had another blockage right below the stent."

"I think Bextra is related to my heart attack. It was strange to me that I had a heart attack at 49 years old, when my only health problem was arthritis. I was in excellent health, never sick," says Woolley. "I never went to a doctor for anything except when I had my kids." Woolley can no longer work, and on some days can barely get around.

Taking Bextra has proven to be a double-edged sword: "I can't take arthritis medication anymore because of my heart so I am in constant pain."

Bextra wasn't removed from the US market until April, 2005. It was approved by the FDA in November, 2001. In just over three years that this drug was on the market, thousands of people unknowingly risked their lives while taking Bextra to prevent inflammation and reduce pain associated with arthritis.

Even after clinical studies indicated that Bextra increased the risk of heart attack and stroke (and also associated the drug with a potentially fatal skin disease known as Stevens-Johnson Syndrome), the manufacturer Pfizer defended its product. The drug company denied claims, citing that a clinical trial did not prove any relationship to Bextra and heart attacks and/or strokes. However, the study only monitored Bextra for less than 52 weeks and it is now known that the risks increase with longer use.

How much longer can drug companies place products on the market without extensive clinical trials? How can Pfizer defend itself when countless people like Sueanne Gatto and Regina Woolley have ruined their lives?