FDA orders warning on Phenergan

Diana Levine fought drugmaker Wyeth all the way to the Supreme Court and won. But what she really wanted after her landmark March victory was just a few small words from government bureaucracy.

Today, she got them. Or at least some of them, in the form of a U.S. Food and Drug Administration order to makers of a drug that caused Levine, a Vermont musician, to lose her arm.

"I'm thrilled," she said in a phone interview, but she added that she was not sure the proposed changes went far enough.

In spring 2000, Levine had a migraine headache and got the drug Phenergan to treat associated nausea. The drug was administered via a method known as intravenous push, which can cause infection and gangrene. That happened to Levine, and doctors amputated her lower right arm.

She sued Wyeth. The case wound up in the Supreme Court, and the decision in Levine's favor was viewed as upholding all consumers' rights to sue drug companies.

A spokesman for Wyeth, which has large operations in Collegeville, would say only that the company no longer sells Phenergan.

But many makers of generic drugs do, and today the FDA ordered them to put the strongest warning possible about the risks of IV push and Phenergan, also known as promethazine, on the drug label.

The stronger warning, sometimes called a "black box," would tell medical professionals that the preferred way to administer promethazine is through intramuscular injection.

Levine said she had hoped the proposed label change would go further and ban IV push. FDA spokeswoman Karen Riley said language highlighting the preferred method and saying that medical professionals who use intravenous methods should do so at low doses would, in effect, eliminate IV push.