Are My Medications Safe?

There has been a great deal of publicity over the withdrawal of Vioxx due to a link between the medication and heart attacks. As with most of these truly tragic situations, the numbers of people adversely affected represent a very small percentage of all the people who were using the medication.

Rather than delve into the specifics of what happened with Vioxx, it may be more useful to look at the process by which medications are reviewed, look at some of the small number of discontinued drugs, and pose some questions to those readers who use prescription medications.

Over the last 7 years, the FDA has pulled about a dozen medications from the market. The amount of time from application to approval of new medications has dropped to 14.6 months in 2000 from 34.3 months in 1993. Of note, pharmaceutical companies that pay the FDA special fees can get a fast-track review.

Some critics have said that the FDA is approving drugs too rapidly, while others criticize the agency for being too deliberate and slow. The commissioner of the FDA has stated that the number of drug withdrawals is unchanged from when reviews were slower.

A new issue to contend with is the direct advertising of medications. Direct advertising to the general population creates a demand and often implies that the "latest must be the best." This is not always the case and creates problems for physicians and patients due to cost and access issues, and might also accelerate the development of difficulties due to unknown adverse effects.

The following are some of the medications that have been withdrawn, their purpose and the reasons for taking them off the market:

• Vioxx (Arthritis), Heart Attacks
• Pondimin (Obesity), Heart Damage
• Redux (Obesity), Heart Damage
• Baycol (Cholesterol), Muscle Damage
• Rezulin (Diabetes), Liver damage
• Lotrenex (Irritable Bowel), Intestinal Injury
• Trovan (Antibiotic), Liver Damage
• Seldane (Antihistamine), Toxic Cross-Reactions
• Hismanal (Antihistamine), Toxic Cross-Reactions
• Raxar (Antibiotic), Irregular Heartbeats

What's a patient to do?
Consider the following questions:

1. Do I really need this medication? Many prescriptions are written for problems that are largely self-limited. Colds, flu-like illnesses, sore throats and minor injuries can often be managed with no medications.
2. Is there a medication that has been out for sometime that may be just as effective? Newer medications are not always better and usually cost much more.
3. Will this medication cross-react with any other drugs that I am taking (including over-the-counter medications)? Many doctors carry pocket references to look this up on the spot; offices with electronic medical records have built-in programs to check for adverse reactions. Most pharmacists will also advise if that is a problem.
4. What can I change about my lifestyle to remove the need for this medication? People who are willing to lose weight, eat healthily, exercise or quit smoking might then be able to discontinue medications to treat high blood pressure, diabetes, elevated cholesterol, GERD, arthritis, etc.

It's your body, your life, and - as health care costs are increasingly shifted to the consumer - it's your dime. Be a wise and careful consumer.

"Your Health" provides easy-to-understand information about common health conditions.