Are Old Drugs Safer than New Ones?

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Are Old Drugs Safer than New Ones?

 

Researchers Call on FDA to Raise Threshold for Approval

By Salynn Boyles

 

http://content.health.msn.com/content/article/1689.52756

 

April 30, 2002 -- The average American sees nine commercials a day

touting a new prescription drug. But a rash of deaths and drug recalls

has many questioning whether newly approved drugs have been adequately

tested. Should they be prescribed when older drugs with proven safety

records can be used?

 

 

In a new study, Harvard Medical School researchers called on the FDA to,

" consider raising its threshold for approving new drugs when safe,

effective therapies already exist. " The Harvard group calculated that a

new drug has a one-in-five chance of causing death or serious injury due

to unforeseen side effects. The study was published in the May 1 issue

of The Journal of the American Medical Association.

 

 

" The FDA needs to study these drugs more extensively in the pre-approval

process, and only approve those drugs that appear to be safe and that

really represent an improvement over current therapies, " lead author

Karen E. Lasser, MD, MPH, tells WebMD. " And the public needs to be made

aware that the new drugs they see on television probably don't have

proven safety records. "

 

 

A Thousand Deaths

 

 

In the early 1990s, Congress passed legislation designed to accelerate

the approval process for drugs used to treat " serious or

life-threatening " conditions, in response to demands from the AIDS

community for quicker access to newer and better treatments. Between

1992 and 1999, the FDA approved 232 new drugs, compared with 163

approved during the previous seven-year period.

 

 

According to an investigation by the Los Angeles Times, seven drugs

approved in the 1990s, but later withdrawn, are suspected of having

caused 1,002 deaths. Experts told the paper that the number of deaths

and serious injuries may be much higher, because doctors are not

required to report adverse drug reactions to the FDA.

 

 

The dead included 3-month-old Scott Englebrick, who was given the drug

Propulsid for stomach reflux, a common condition of infancy. Approved in

1993, despite evidence that it caused heart rhythm disorders, Propulsid

was not specifically marketed for infants, but it quickly became the

drug of choice for many pediatricians.

 

 

The infant's 1997 death was, disturbingly, not the first or the last

pediatric death linked to the medication. The LA Times reports that

eight children who had been given Propulsid in studies prior to the

drug's approval had died. By the time it was removed from the market in

March of 2000, the medication had been implicated in more than 300 deaths.

 

 

Other drugs that were approved during the 1990s and later withdrawn from

the market include:

 

 

Redux -- Approved in April 1996 and withdrawn the next year, the weight

control drug has been implicated in 123 deaths due to heart valve

damage. It is estimated that Redux marketer American Home Products

Corp., will end up paying more than 10 billion in damages to people who

took the drug.

Rezulin -- A diabetes drug approved in 1997 and withdrawn in 2000 after

being implicated in more than 60 deaths from liver failure. The LA Times

report suggests the drug may be responsible for almost 400 deaths.

Posicor -- The blood pressure drug was approved in June 1997, despite

FDA findings linking it to heart rhythm problems. It is implicated in

close to 100 deaths.

Duract -- A painkiller withdrawn from the market just 11 months after

approval due to reports of liver toxicity. It is suspected in almost 70

deaths.

Raxar -- The antibiotic was suspected of causing 13 deaths from heart

rhythm problems prior to being taken off the market in October 1999,

just two years after its approval.

FDA Response

 

 

In the newly released Harvard study, Lasser and colleagues examined all

548 drugs approved between 1975 and 1999. They found that one in 10 was

subsequently withdrawn from the market (16) or required additional

safety labeling (45) known as a black box warning. Half of the

withdrawals occurred within two years, and half of all changes occurred

within seven years.

 

 

The researchers call on the FDA to adopt tougher approval standards for

new drugs that offer few advantages over existing ones. But an FDA

spokesperson says new standards are not needed. '

 

 

Robert J. Temple, MD, tells WebMD that the FDA and drug developers can

now reliably identify two major causes of adverse drug reactions --

interaction with other drugs and a potential to cause life-threatening

heart rhythm problems. Temple is associate director for medical policy

at the FDA's Center for Drug Evaluation and Research Policy.

 

 

" These two things will not surprise us again, " he says. " We now know

about the interaction potential for every drug we approve. "

 

 

So how much risk is acceptable? That depends on what the drug is used

for, Temple says, and it is not always easy to calculate. The irritable

bowel drug Lotronex was linked to five deaths prior to being pulled from

the market in November 2000. But pleas from patients with the condition

led to a meeting of an FDA advisory committee that recommended resuming

sale of the drug -- with strict limits.

 

 

" For some of these patients, the potential risks are acceptable, because

this drug allowed them to lead normal lives, " he says. " We accept

massive toxicity in drugs for cancer and AIDS because these diseases are

deadly and there are no safer ways to treat them. We always have to

consider the risks versus benefits. "

 

 

© 2002 WebMD Inc. All rights reserved.