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Drug Side Effects Can Be Funny, Scary

Symptoms Of Medication Can Match Disease

POSTED: Thursday, April 10, 2008

Since the FDA loosened up television direct-to-consumer advertising standards for drug companies in 1997, it's difficult to sit though an evening of watching your favorite shows without seeing an advertisement for some prescription drug.

A humorous side effect of these TV commercials can often be the side effects that come with the drug. Who can't help but crack a smile when they see that Viagra commercial saying if you experience an erection that lasts for more than four hours to call a doctor?


Allergic Reactions | Drug Recalls

Before 1997, drug ads had to list broad information about side effects, which made advertising not particularly viable. But after '97, drug companies only had to list common side effects, which seem to be getting weirder and weirder.

Consumer's Union conducted a poll that shows one in six Americans have taken a prescription drug and experienced a side effect serious enough to require a doctor or hospital visit.

A commercial for Mirapex -- which is given to treat Parkinson's disease as well as restless leg syndrome -- says at the end to tell your doctor if you experience increased gambling, sexual or other intense urges.

Vasotec, given to treat high blood pressure, can cause a loss of taste sensation.

Paxil is a drug that is prescribed for depression, obsessive-compulsive disorder, anxiety disorders, and post-traumatic stress disorder.

According to Drugs.com, possible side effects of Paxil include mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania, thoughts of suicide or hurting yourself.

Are these really any different from the symptoms one suffers through with depression, or perhaps even worse?

Ambien Has Many Effects

Ambien, the most popular prescription sleep aid in the United States with over 26 million users, according the New York Times, has a long list of strange side effects.

You don't have to read more than two sentences on Ambien's Web site before getting a warning: "Until you know how AMBIEN CR will affect you, you shouldn't drive or operate machinery."

Drugs.com lists possible side effects of Ambien, saying, "Some people using this medicine have engaged in activity such as driving, eating or making phone calls and later having no memory of the activity."

The first paragraph of Ambien's Web site also says, "In rare cases, sleep medicines may cause allergic reactions such as swelling of your tongue or throat, shortness of breath or more severe results ... Side effects may include next-day drowsiness, dizziness, and headache."

Like with other medications, the drug may have the same effect as the symptoms it is trying to treat. Is not the biggest result of a restless night of sleep next-day drowsiness?

Making Fun Of Effects

Perhaps the greatest parody of side effects was the old "Saturday Night Live" skit, "Happy Fun Ball." While the skit was about a child's toy and not about prescription drugs, it accurately mirrors the sometimes hilarious list of side effects that come at the end of drug commercials.

A voiceover at the end of the fake commercial says, "Happy Fun Ball contains a liquid core, which, if exposed due to rupture, should not be touched, inhaled or looked at ... Ingredients of Happy Fun Ball include an unknown, glowing substance which fell to Earth, presumably from outer space."

Then comes a long list of side effects that includes itching, vertigo, dizziness, tingling in extremities, loss of balance or coordination, profuse sweating, slurred speech, temporary blindness, heart palpitations and a warning, "Do not taunt Happy Fun Ball."

Why The Warnings?

So, why would a drug company want to advertise its product if it will be ridiculed by late-night talk shows because it has to list sometimes embarrassing side effects?

Take weight-loss aid Alli, for example, which became a late-night punch line when it had an ad that recommended users wear dark pants and bring a change of clothes with them until they understood the drug's gastrointestinal effects.

The reason for the ads, regardless of their embarrassing side effects, is simple.

"The bottom line is, it works," said Susan Herald of Consumer's Union. "True, you still need your doctor to write the prescription, but you can see in the statistics how prescription use has skyrocketed since DTC advertising has been allowed."

A 2006 study by the United States General Accounting Office found that regardless of the safety and effectiveness of a drug, advertising always increases the sale of a drug, and that drug advertising increases sales 20 percent faster than sales for drugs that are not heavily advertised to consumers. In one study of 64 drugs, the GAO found a median increase in sales of $2.20 for every $1 spent on advertising.

Consumer's Union did a study that shows only 35 percent of consumers know they can report adverse side effects to the FDA. Simply reporting the side effect to a doctor does not guarantee that it will get reported to the FDA.

"The only requirement is that the drug makers report adverse events (to the FDA)," said Herold. "So physicians and consumers and pharmacists are not required."

A spokeswoman for the American Medial Association said the AMA has not taken a specific position on the FDA requiring its number to be included in all television advertising.

On its Web site, the AMA does have a page dedicated to its position on DTC advertising.

On the Web site, it says, "The advertisement should exhibit fair balance between benefit and risk information when discussing the use of the drug or implantable medical device product for the disease, disorder, or condition. The amount of time or space devoted to benefit and risk information, as well as its cognitive accessibility, should be comparable."

To help make consumers more aware of the FDA's reporting system, Consumer's Union gathered 56,000 signatures asking that the FDA require its toll-free number and Web site be included in all TV drug ads. FDA regulations at the moment only require them in print ads.

Last year, Congress called for the FDA to conduct a study of TV prescription drug ads and issue any required regulations.

"As far as we can tell they haven't done the study and we're just trying to push them to do this," said Herold. "The way the legislation is written, once they do the study, (Congress) leaves it up to the FDA commissioner to issue regulations."

More Info:

  • No Magic Pill For Drug Safety
  • Can Tests Spot Risky Side Effects?
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