Painkiller Drugs Safety. They were hailed as wonder drugs, stopping pain without side effects, but their claims turned out to be too good to be true. Up next, the story the pain these painkillers brought to one family.
COSTELLO: For months we’ve heard sometimes conflicting reports on the safety of painkillers, such as Vioxx or Celebrex. Beginning tomorrow, the FDA will hold hearings on the risks and benefits of the drugs and to see if they’re safe enough to sell.
More now from CNN medical correspondent Dr. Sanjay Gupta.
SANJAY GUPTA, CNN SENIOR MEDICAL CORRESPONDENT
nita Glover suffered with arthritis, and, like 20 million other Americans, her doctors prescribed Vioxx. Vioxx, along with Celebrex and Bextra, make up a class of pain drugs called COX-2 inhibitors.
They came on the scene in the late ’90s, and many people considered them to be miracle drugs. They stopped the pain, didn’t bother your stomach, and in the meantime, made millions of dollars for drug companies.
But Robert Glover, Anita’s son, believes Vioxx is behind a tragic day in 2001 that he says he’ll never forget.
ROBERT GLOVER, MOTHER TOOK VIOXX: She collapsed in the hallway on the floor, was having trouble breathing, was in real distress. And at that point we called 911, and we had the ambulance show up. And they took her to emergency. And she passed away of a heart attack.
And it’s just this kind of story that an FDA committee will be investigating this week
GUPTA: And it’s just this kind of story that an FDA committee will be investigating this week as evidence mounts that the COX-2 drugs may do more harm than good.
GLOVER: She read all the drug warnings. She felt that, you know, everything all the research had been done on it, and it was a safe drug for her.
GUPTA: But medical community insiders have been worried about this problem since the drugs came out.
DR. LAURENCE SPERLING, EMORY UNIVERSITY CARDIOLOGIST: Initially, about four years ago or so, there were questions related to the possible heart side effects of these medications.
GUPTA: And now fast-forward to the fall of 2004.
RAYMOND GILMARTIN, CEO, MERCK & CO.: The risk of a cardiovascular event did increase among those on Vioxx. Accordingly, we are voluntarily withdrawing Vioxx, effective today.
GUPTA: Then, just three months after Vioxx was pulled from the market over heart attack concerns, the National Cancer Institute halted a study using a similar drug, saying it found the same increased heart risk in those taking Celebrex.
Pfizer, the makers of Celebrex, said that these results were inconsistent with data in other clinical trials
Pfizer, the makers of Celebrex, said that these results were inconsistent with data in other clinical trials, and decided to keep the drug on the market. But both Pfizer and the FDA warned doctors to consider all of the risks before prescribing it to their patients.
We spoke with one doctor who heeded their warning.
SPERLING: Right now, with our available information, I would say that I’d be a little wary of prescribing Celebrex to you right now.
GUPTA: Four days after problems with Celebrex were announced, another trial was halted over similar heart concerns. This time, the drug in question was Naprosen, the active ingredient in the over-the- counter pain reliever Aleve. But the drug’s manufacturer, Bayer, says Aleve is safe when used as directed.
While these concerns are just being brought to the public’s attention, Robert Glover has been aware of the problems with Vioxx since his mother’s death in 2001.
GLOVER: Unfortunately, she took the drug thinking that, you know, it was going to help her, but she didn’t think it would hurt her.