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• How many drugs are currently approved by the Food and Drug Administration?
• How much do pharmaceutical companies spend to research and develop a new drug?
• Does FDA approval mean that a prescription drug is safe?
• How many Americans are hospitalized each year due to adverse reactions to medications?
• What are some of the possible reactions a person might experience if he or she misreads the medication directions or misuses the medication?
• What is a dietary supplement?
• What is a "new dietary ingredient" in a dietary supplement?
• What is the FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
• What information must the manufacturer disclose on the label of a dietary supplement?
• Must all ingredients be declared on the label of a dietary supplement?
• What is an anabolic steroid precursor?
• What is Androstenedione?
• What is Vioxx?
• Did the FDA require the recall of Vioxx?
• What action did the FDA take today?
• What should I do if I am currently taking Vioxx?
• What are the likely long-term health effects, if any, of taking this product?
• What evidence supports the Public Health Advisory?
• Why wasn’t the APPROVe trial stopped earlier?
• What did the FDA know about the risk of heart attack and stroke when it approved Vioxx?
• Is the FDA’s expedited review process putting riskier drugs on the market?
• What other drugs are similar to Vioxx?
• Does today’s action suggest that other drugs in the same class are dangerous?
• Will Vioxx be recalled?
• Can my pharmacist continue to fill my prescription for Vioxx?

To date, more than 5,000 prescription medications are approved by the FDA. An average of five new prescription drugs are added to the list approved each month.

According to the 1993 Congressional Offices of Technology Assessment, drug companies spend an average of $359 million to develop a new drug for the general public. Since the 1993 study was completed, the cost of research and development for new drugs has no doubt skyrocketed.

We wish that were the case; however, the long list of previously approved drugs that are now or have been the subject of recalls and class action lawsuits tells us otherwise.

Each year, an average of 300,000 people are hospitalized due to adverse reactions to medications.

Possible reactions include, but are by no means limited to, the medication losing its effect, leading to patient relapse, or causing serious, adverse reactions to the medication, including death.

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. For an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:

• A vitamin
• A mineral
• An herb or other botanical
• An amino acid
• A dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands)
• A concentrate, metabolite, constituent or extract

A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the United States in a dietary supplement before October 15, 1994.

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from the FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide the FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives and flavors).

Who has the responsibility for ensuring that a dietary supplement is safe?

By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proved safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to the FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, the FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace.

An anabolic steroid is a steroid, such as testosterone, that induces muscle growth. An anabolic steroid precursor is a steroid that does not itself cause muscle growth, but can be converted by the body into such a steroid. Androstenedione is an anabolic steroid precursor because it is converted to testosterone in the body.

Androstenedione is converted to testosterone and estrogen, and when taken in sufficient quantities, androstenedione can cause masculinizing and feminizing effects. Androstenedione is considered an androgenic steroid precursor because testosterone is an androgen, or male hormone.

Vioxx is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults and painful menstrual cycles.

No, Merck made this decision independent of input from the FDA. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.

The FDA plans to work closely with Merck to coordinate the withdrawal of this product from the U.S. market.

The FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co., Inc., voluntarily withdrawing Vioxx from the market due to safety concerns.

The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small. We encourage people taking Vioxx to contact their physician to discuss discontinuing use of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.

The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.

Merck’s decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [Adenomatous Polyp Prevention on VIOXX] trial. In the APPROVe trial, Vioxx was compared with placebo (sugar-pill). The purpose of the trial was to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.

The APPROVe trial began enrollment in 2000. The trial was being monitored by an independent data safety monitoring board (DSMB). It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events on Vioxx.

The FDA originally approved Vioxx in May 1999. The original safety database included approximately 5,000 patients on Vioxx and did not show an increased risk of heart attack or stroke. A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID; the study, however, also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee meeting and the new safety information from this study was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

No. Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding. A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval.

Vioxx is a COX-2 selective, non-steroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you.

The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. All of the NSAIDs have risks when taken chronically, especially of gastrointestinal (stomach) bleeding, but also liver and kidney toxicity. Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a physician.

The FDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.

No. Merck is initiating a market withdrawal in the United States to the pharmacy level. This means Vioxx will no longer be available at pharmacies.

Pharmaceuticals / Dietary Supplements If you think you may need an attorney for such a case in the Tampa Bay, Florida area, [ contact us today ].

DISCLAIMER - Please note that the answers to these questions should not be construed as legal advice as all situations differ, and you should always consult with a lawyer before making any decisions regarding injury claims or other legal matters referred to herein. These answers are intended to provide general information only.