More Problems after Fast Drug Approvals A new study adds to the evidence that serious side effects of new drugs often show up later. It also shows that drugs approved through a fast-track process may be more likely to have problems. The study looked recent drug approvals in Canada and what was learned about the drugs after approval. Researchers focused on 434 drugs. They were approved between 1995 and 2010. Most drugs went through a 300-day standard approval process. About 1 out of 4 went through a 180-day process. The fast process is used if a condition has no good treatments, or if the new drug may offer a major advantage over current treatments. Of the drugs that went through the standard process, one-fifth became the subject of a serious safety warning or were withdrawn from the market. These problems occurred for about one-third of drugs that went through the fast approval process. The journal Archives of Internal Medicine published the study online. Canada's National Post newspaper wrote about it October 11.

By Mary Pickett, M.D.
Harvard Medical School

What Is the Doctor's Reaction?

Americans are taking vastly more drugs today than we did in previous generations. And this decade has been an age for new drugs. In just the first several years of the 2000s, the U.S. Food and Drug Administration (FDA) approved roughly 100 new drugs. This was remarkable. It was about the same number of drugs that were approved during the 20 years leading up to 2000. And more new drugs continue to come on to the market in a steady stream.

In order to get approval, drugs must be studied and shown to be both helpful and safe. But there are pressures on the FDA to hurry approvals.

Pre-approval drug studies show short-term safety, but they can't look at safety over the long term. For this, we need to try out new drugs and see what happens with long-term use.

How safe are new drugs?

A study from Canada gives us a hint at this answer. Researchers looked at drugs approved in Canada from 1995 to 2010. Here is what they found:

• About 1 in 5 drugs approved through a standard review process was later found to have a serious safety issue. These were the kind of issues that would lead to a "black box warning" on the label by our FDA.
• Some drugs, such as cancer drugs, go through a more hurried process. The purpose is to make them available as quickly as possible. Drugs that went through this faster review process were even more likely to have problems. About 1 in 3 of these drugs was found later to have a serious safety issue.

As a doctor, I like to let a good deal of time pass before I prescribe a new drug. Old drugs are not only more trustworthy, they also usually cost less.

One problem for doctors is to keep track of the many ways that medicines can interact with each other. This is a tough job when the list of medicines is ever growing.

Each new drug is a welcome tool to fight symptoms or disease. But the more drugs we have, the more drug combinations are possible.

Drug interactions are not always predictable. Some are discovered only with trial and error, long after a drug is approved.

What Changes Can I Make Now?

• Let other people be the first to try a new medicine for your condition. You can learn a lot about a drug if you have the patience to watch and wait for a few years. Then you can see how well doctors, patients and the FDA rate the drug after it has been out on the market for a while.



• Keep your drug list simple. This is not always easy. For example, 12% of women over 65 years old take more than 10 medicines regularly. But it helps to cut out medicines you take "as needed," if you truly need them only rarely. Another way to limit your drug list is to take only those that you and your doctor both consider to be high priority for you.



• Be careful about advertising. Direct-to-consumer advertising can educate the public about a disease. Ads on TV, for example, might encourage someone to seek treatment for a condition that otherwise would not be addressed. However, direct marketing is also a hazard. Ads can be misleading. Medical evidence is complex. Advertisers simplify information in ways that are not always fair. Medicines that are heavily advertised tend to be new, and they tend to be expensive. They may or may not be the most practical choice for you.

What Can I Expect Looking to the Future?

Fortunately, some of the new medicines that are destined to appear on the market soon are generic versions of several "blockbuster" medicines. They should help with one other big problem that our many medicines cause: the pill bill.