A drug's comeback
Published: Sunday, April 14, 2013 at 6:01 a.m.
Last Modified: Friday, April 12, 2013 at 3:35 p.m.
My mother was livid, not the reaction that you typically associate with the latest pharmaceutical news.
She had just emailed me an Associated Press story reporting that a morning-sickness drug pulled off the market 30 years ago has again won Food and Drug Administration approval.
It was called Bendectin back then, but will return to U.S. pharmacies under the name Diclegis.
"If it's so safe, why did they change the name?" my mom said.
When she was pregnant with me, she took Bendectin. She had been so nauseated from morning sickness that it made going to work difficult.
When I was born with clubfeet, she suspected the drug was the cause. Other parents also believed their children's birth defects were related to the drug, leading to hundreds of lawsuits that forced Bendectin off the market in 1983.
The AP story referred to the safety scare as a "false alarm." In the last few decades, the drug has undergone more scrutiny than any other drug used during pregnancy, according to the report.
The ingredients of the drug seem innocuous and obstetricians have been telling patients for years how to mix the right dose themselves. Its reintroduction was praised by the medical director of the March of Dimes.
But in the dark corners of the Internet, the news received a less enthusiastic response from parents who claimed it caused problems in their children ranging from bipolar disorder to heart defects.
The nonprofit group Birth Defects Research for Children's website cites reports questioning its safety and a scathing decision from a judge who ruled against the maker of the drug. Group director Betty Mekdeci took Bendectin during pregnancy and gave birth to a son missing a hand, leading her to file one of the first lawsuits.
I called Mekdeci and, suffice it to say, she's not convinced the drug is safe to be reintroduced. She questioned the fact it had been tested on just 261 women who were pregnant at least seven weeks, which she said left out the early stage of pregnancy when defects can happen.
I also spoke with Dr. W. Thomas Smith, director of the University of Florida's online programs in pharmaceutical outcomes and policy. While not specifically familiar with the the drug's reintroduction, he knew about the legal history of Bendectin because it led the U.S. Supreme Court to rule that judges must keep junk science out of courts.
He outlined the rigorous process required before a drug gets U.S. approval. While there are multiple levels of tests to assure a drug is safe, he said, there are still cases in which it wasn't tested in certain populations or for off-label uses later found to cause problems.
I'm a big believer in modern medicine and think it's dangerous to use junk science to suggest things like children shouldn't get immunizations. But I also feel that people turn too quickly to pharmaceuticals, when lifestyle changes and traditional therapies sometimes work better.
Smith said the approval process helps assure drugs are safe, but that doesn't mean they're without risk.
"The only way to make sure a drug is 100 percent safe is to not to take it at all," he said.