Y
Yaps
FDA scientist details problems of five drugs
By Liz Szabo and Rita Rubin, USA TODAY
During a Senate hearing Thursday regarding Vioxx, the arthritis blockbuster pulled off the market in September over concerns about increased risk of heart attacks and strokes, FDA scientist David Graham dropped a bombshell about five other drugs on the U.S. market. Graham, associate director for science in the FDA's Office of Drug Safety, said the five drugs pose serious safety concerns:
? Abbott Laboratories' weight-loss drug Meridia can cause high blood pressure, Graham said. When he raised a question about the drug's usefulness in a report, though, Graham said he was forced to delete it. Abbott spokeswoman Laureen Cassidy defended Meridiaby saying it has been studied in morethan 100 studies and has been used by 15 million patients worldwide. (Related story:Scientist says FDA system 'broken')
? AstraZeneca's Crestor is the "only cholesterol-lowering drug that causes acute kidney failure," Graham said. Emily Denney, a spokeswoman for AstraZeneca, says the drug has been prescribed to more than 3.5 million people worldwide and has been extensively tested.
? Roche's drug Accutane, approved to treat severe acne, is a "20-year regulatory failure," Graham said. Accutane can cause serious birth defects if taken by pregnant women, he said, and the agency's efforts to prevent this problem are ineffective. He said the FDA should institute a system that would restrict the distribution of the drug. Carolyn Glynn, a Roche spokeswoman, said the company will now require all patients ? as well as their doctors and pharmacists ? to register with an independent agency that will track patient use.
? Pfizer's arthritis medicine Bextra is in the same drug class as Vioxx. A recent study showed that the incidence of heart attacks and strokes among Bextra patients was more than double that of patients taking sugar pills. Pfizer spokeswoman Susan Bro says an analysis of previous studies found no increase in "serious cardiovascular events" in nearly 8,000 arthritis patients.
? GlaxoSmithKline's drug Serevent treats asthma and chronic obstructive pulmonary disease. Before the FDA approved this asthma drug, a British study found with 90% certainty that it increased the risk of death from serious asthma complications, Graham said. There have been reports of patients "found dead clutching their Serevent inhaler," he said. GlaxoSmithKline issued a statement defending the medication, saying the FDA "fully considered" safety concerns last year when it issued a black box warning in the medicine's label.
It was clear Thursday that Graham was not speaking on behalf of the FDA. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, told committee members there's no evidence that these five drugs are any more dangerous than others.
Graham's testimony hurt the manufacturers' stock prices. AstraZeneca dropped $3.80 or 8.6%. GlaxoSmithKline dropped $1.45 or 3.2%. Pfizer was down 22 cents, or 0.8%, while Abbott Laboratories was down 28 cents, or 0.6%. Roche, a Swiss company, doesn't trade on U.S. exchanges.
By Liz Szabo and Rita Rubin, USA TODAY
During a Senate hearing Thursday regarding Vioxx, the arthritis blockbuster pulled off the market in September over concerns about increased risk of heart attacks and strokes, FDA scientist David Graham dropped a bombshell about five other drugs on the U.S. market. Graham, associate director for science in the FDA's Office of Drug Safety, said the five drugs pose serious safety concerns:
? Abbott Laboratories' weight-loss drug Meridia can cause high blood pressure, Graham said. When he raised a question about the drug's usefulness in a report, though, Graham said he was forced to delete it. Abbott spokeswoman Laureen Cassidy defended Meridiaby saying it has been studied in morethan 100 studies and has been used by 15 million patients worldwide. (Related story:Scientist says FDA system 'broken')
? AstraZeneca's Crestor is the "only cholesterol-lowering drug that causes acute kidney failure," Graham said. Emily Denney, a spokeswoman for AstraZeneca, says the drug has been prescribed to more than 3.5 million people worldwide and has been extensively tested.
? Roche's drug Accutane, approved to treat severe acne, is a "20-year regulatory failure," Graham said. Accutane can cause serious birth defects if taken by pregnant women, he said, and the agency's efforts to prevent this problem are ineffective. He said the FDA should institute a system that would restrict the distribution of the drug. Carolyn Glynn, a Roche spokeswoman, said the company will now require all patients ? as well as their doctors and pharmacists ? to register with an independent agency that will track patient use.
? Pfizer's arthritis medicine Bextra is in the same drug class as Vioxx. A recent study showed that the incidence of heart attacks and strokes among Bextra patients was more than double that of patients taking sugar pills. Pfizer spokeswoman Susan Bro says an analysis of previous studies found no increase in "serious cardiovascular events" in nearly 8,000 arthritis patients.
? GlaxoSmithKline's drug Serevent treats asthma and chronic obstructive pulmonary disease. Before the FDA approved this asthma drug, a British study found with 90% certainty that it increased the risk of death from serious asthma complications, Graham said. There have been reports of patients "found dead clutching their Serevent inhaler," he said. GlaxoSmithKline issued a statement defending the medication, saying the FDA "fully considered" safety concerns last year when it issued a black box warning in the medicine's label.
It was clear Thursday that Graham was not speaking on behalf of the FDA. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, told committee members there's no evidence that these five drugs are any more dangerous than others.
Graham's testimony hurt the manufacturers' stock prices. AstraZeneca dropped $3.80 or 8.6%. GlaxoSmithKline dropped $1.45 or 3.2%. Pfizer was down 22 cents, or 0.8%, while Abbott Laboratories was down 28 cents, or 0.6%. Roche, a Swiss company, doesn't trade on U.S. exchanges.
