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People with some medical conditions may be at risk for serious or life-threatening side effects when using certain over-the-counter (OTC) drug products. The FDA has published new rules to enhance the safe use of such products.
The rules, which became effective in April 2004, require the labeling of oral OTC drugs containing sodium, calcium, magnesium, or potassium to state the amount of the ingredient in each dose (content labeling). The labels must also state that these ingredients might be harmful to people with certain underlying medical conditions (warning labeling). These new warnings provide an extra level of safety for people who may be especially sensitive to these commonly used OTC ingredients. Mouth rinses, fluoride toothpastes, and mouthwashes are not covered by this regulation.
The rules also require new warnings on the label to alert people to consult with their physician before using OTC products if they have kidney stones, decreased kidney function due to kidney disease, or are on sodium, calcium, magnesium, or potassium-restricted diets. In addition, the agency is proposing to extend sodium content labeling requirements to OTC rectal drug products containing sodium phosphates.
For specific dose restrictions, see www.fda.gov/bbs/topics/news/2004/NEW01041.html.
The FDA has approved Taxotere (docetaxel) injection in combination with prednisone (a steroid) for treating men with advanced prostate cancer that no longer responds to hormone therapy (hormone refractory prostate cancer). Taxotere is the first drug approved to treat prostate cancer that has shown it can help extend a man's life.
"We consider this approval an important advance in the treatment of prostate cancer because it can help some patients live longer," Dr. Lester M. Crawford, Acting FDA Commissioner, said in announcing the approval in May 2004. "Patients need as many effective treatment options as possible, and Taxotere, in combination with prednisone, offers hope to certain patients who have not responded to other treatments."
Taxotere works by inhibiting tubulin, a protein essential to cell division, thus preventing cancer cells from dividing and growing in number.
Treatment with Taxotere and prednisone was compared with treatment with the cancer drug mitoxantrone and prednisone in a clinical trial involving more than 1,000 men with hormone refractory prostate cancer that had spread beyond the prostate gland. The men given Taxotere every three weeks lived about 2.5 months longer than the men given mitoxantrone every three weeks. Both groups received prednisone twice a day on a continuous basis.
The most common side effects reported were nausea, hair loss (alopecia), and bone marrow suppression. In addition, fluid retention and tingling sensations in the extremities (peripheral neuropathy), known effects of Taxotere, also were seen.
Prostate cancer is the second leading cause of cancer death in men. The American Cancer Society estimates there will be about 230,900 new cases of prostate cancer in the United States in 2004. About 29,900 men will die of the disease this year alone.
Taxotere is distributed by Aventis Pharmaceuticals Inc. of Bridgewater, N.J.
The first drug for treating dogs with diabetes has been approved by the FDA. Prior to the development of this insulin, the only treatments veterinarians could use on dogs with diabetes were insulin products approved for use in humans. While diabetes in dogs can be controlled with most available insulin products, this new insulin was developed to exactly match the amino acid sequence of natural dog insulin, and the labeling includes dosing and safety information specific to dogs.
Experts estimate that 1 in every 200 dogs will develop diabetes. It usually begins in dogs ages 7 to 9 years old and seems to occur twice as often in females as in males.
The drug, a zinc suspension of purified pig insulin, will be marketed under the trade name Vetsulin by its developer, Intervet Inc. of Millsboro, Del. A veterinarian must prescribe it.
Vetsulin, which is injected just beneath the skin, will be used to improve the control of blood glucose levels and the signs of diabetes in dogs, such as weight loss and excessive thirst, urination, and appetite. Veterinarians will determine the initial treatment dose based on the dog's weight and then will use various tests to adjust the dosage to the optimum level. Dog owners will be given instructions for continuing the treatment at home, as well as an information sheet that outlines the benefits and risks of the treatment.
One of the risks dog owners may face is dangerously low blood glucose levels (hypoglycemia) if they accidentally inject themselves with the insulin. The product contains warning statements on the label about this risk as well as others, such as the need to prevent eye exposure to the insulin.
Vetsulin has already been approved in 20 countries, including the United Kingdom, and should be available in the United States in late summer 2004.
Americans' vulnerability to foodborne illness has been highlighted by large outbreaks in recent years. To increase awareness, an updated educational guide for health care professionals on how to identify, treat, and prevent foodborne illnesses, as well as consumer tips for patients, has been prepared by a group of professional associations and government agencies.
The free, easy-to-read guide, Diagnosis and Management of Foodborne Illnesses: A Primer for Physicians and Other Health Care Professionals, is a revision of a publication originally done in 2001. The updated version contains five new sections on new and re-emerging foodborne illnesses, as well as charts, scenarios, and a continuing medical education section.
After microbes that produce illness are swallowed, they pass through the stomach into the intestine, attach to the cells lining the intestinal walls, and begin to multiply. According to the Centers for Disease Control and Prevention (CDC), some types of microbes stay in the intestine, some produce a toxin that is absorbed into the bloodstream, and some can directly invade the deeper body tissues. The symptoms produced, including diarrhea, abdominal cramps, and nausea, depend greatly on the type of microbe. It is rarely possible to say which microbe is likely to be causing a given illness unless laboratory tests are done to identify the microbe, or unless the illness is part of a recognized outbreak.
"Recent concerns about hepatitis A and norovirus outbreaks have emphasized the need for health professionals to be vigilant for foodborne pathogens, and this need is further emphasized by concerns about intentional contamination of food," says David Acheson, M.D., director of the Food Safety and Security Staff at the FDA's Center for Food Safety and Applied Nutrition.
More than 75 percent of foodborne illness deaths are caused by just three pathogens: salmonella, listeria, and toxoplasma. Greater understanding of foodborne illnesses by nurses and other front-line health care providers is also important for early detection. Collaborators on the primer include the American Medical Association (AMA), American Nurses Association-American Nurses Foundation, the CDC, the FDA's Center for Food Safety and Applied Nutrition, and the U.S. Department of Agriculture's Food Safety and Inspection Service.
Health care professionals can request a free copy of the primer by visiting the AMA Web site. Consumer tips on food safety also are available at this site.
The FDA recently approved the use of oral fluid samples with a rapid HIV diagnostic test kit that provides screening results in about 20 minutes with over 99 percent accuracy. The approval of the OraQuick Rapid HIV-1/2 Antibody Test for use with oral fluid represents a significant new use for a test that was approved previously for use on blood samples. The test can quickly and reliably detect antibodies to HIV-1, can be stored at room temperature, and requires no specialized equipment.
The person being tested for HIV-1 takes the device, which has an absorbent pad at one end, and places the pad above the teeth and against the outer gum. He or she gently swabs completely around the outer gums, both upper and lower, one time around. The tester then takes the device and inserts it into a vial containing a solution. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device.
The original version of this rapid test, manufactured by OraSure Technologies Inc. of Bethlehem, Pa., was approved in 2002 for the detection of antibodies to HIV-1 in blood. In March 2004, the FDA approved the test for detection in blood of HIV-2 (a variant of HIV that is prevalent in parts of Africa but rarely found in the United States).
The Centers for Disease Control and Prevention (CDC) has estimated that one-fourth of the approximately 900,000 people infected with HIV in the United States are not aware that they are infected. Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services have worked with state and other health officials to make the test widely available and to offer technical assistance and training for its use.
As with all HIV screening tests, if the OraQuick test is positive, that result must be confirmed with an additional, more specific test.
The OraQuick test has not been approved to screen blood donors. And although the test is approved to detect antibodies to HIV-1 and HIV-2 when used on blood, the recent FDA approval of the test for use on oral fluid is limited to detection of antibodies to HIV-1.
People with Parkinson's disease now have a new treatment available for episodes of hypomobility, or "off periods" in which the person becomes immobile or unable to perform activities of daily living.
Apokyn (apomorphine) is an injectable drug that must be taken with an anti-nausea drug because Apokyn can cause severe nausea and vomiting. Apokyn must not, however, be taken with one class of very effective anti-nausea drugs, the 5HT3 antagonists (ondansetron and similar drugs), because the combination can lead to very low blood pressure and loss of consciousness.
Apokyn was given priority review because injectable apomorphine is the first therapy approved to treat hypomobility episodes at the time they occur. It is a new molecular entity--a medication containing an active substance that has never before been approved for marketing in any form in the United States. Apokyn also was designated as an orphan product--one that treats a rare disease affecting fewer than 200,000 people in the United States. Although an estimated 1.5 million Americans have Parkinson's disease, about 10 percent--or 150,000 people--experience episodes of hypomobility within three to five years of treatment with standard drugs.
Apokyn's labeling also includes specific warnings about low blood pressure, fainting, hallucinations, and excessive sleepiness. Apokyn is manufactured for Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., by Draxis Pharma Inc. of Kirkland, Québec.
Certain pancreatic drugs must get FDA approval by April 28, 2008, to remain on the market. The FDA decided to require approval of all pancreatic extract drug products (PEPs) as "new drugs" in April 2004 after reviewing data that showed substantial variations among such products now on the market. PEPs aid in the digestion of meals in people who have diseases affecting the function of the pancreas.
The FDA found that variations in formulation, dosage, and manufacturing processes affected the potency of the drugs, which could significantly affect their safety and effectiveness. "Variations in the potency of pancreatic extract drug products are unacceptable," says Dr. Lester M. Crawford, Acting FDA Commissioner. "If the label contains an inaccurate statement about a particular product's potency, then the patient is at risk for receiving too much or too little of the medicine."
PEPs have a long history of use, some preceding the enactment of the Federal Food, Drug, and Cosmetic Act, which requires FDA approval of new drugs. More than three dozen different PEPs are being marketed. Only one of these products has received formal FDA approval, but it is no longer being sold. The other products continue to be available because of their established use to treat serious conditions associated with the pancreas, including cystic fibrosis (CF) and chronic pancreatitis.
CF is a genetic disease that causes the body to produce thick mucus that obstructs the pancreas, preventing enzymes that help digest food from reaching the intestines. About 30,000 Americans are affected with CF, according to the Cystic Fibrosis Foundation. About 14,000 to 28,000 Americans have pancreatitis, a disease that prevents the pancreas from producing enough enzymes to properly digest fat.
More information on pancreatic drugs is available on this Web site.
McNeil Consumer & Specialty Pharmaceuticals has issued an alert that one manufacturing lot of Children's Motrin (ibuprofen) Grape Chewable Tablets may mistakenly contain an adult dose of acetaminophen--Tylenol 8-hour extended release Geltabs.
The lot number being recalled is JAM108, with an expiration date of 1/06. The lot number is embossed on the carton flap and printed on the label of each bottle. The lot was distributed nationwide to wholesale and retail customers between Feb. 5 and April 1, 2004.
The mislabeled bottles appear to be the result of a packaging error for the one lot. There were 75,000 bottles in the lot, but not all the bottles were affected. As of May 2004, two mislabeled bottles had been identified and no injuries had been reported.
Children's Motrin Grape Chewable Tablets are round, purple, scored tablets with the letters MO and the number 50 on the tablet surface. These tablets have a non-glossy finish and a simulated grape-like smell. The Tylenol 8-hour Geltabs are hard, round, gelatin coated, and shiny. The tablets are white on one side, red on the other, with "8 Hour" printed in blue on either side.
Consumers who discover any bottles in this lot should contact McNeil's consumer relationship center at (800) 962-5357. Parents who believe their children may have taken Tylenol 8-hour Geltabs, believing them to be Children's Motrin chewable tablets, should contact their health care provider or a poison control center immediately.
The public and researchers have a new resource for information on gene therapy studies. The Genetic Modification Clinical Research Information System (GeMCRIS) is a Web-accessible database on human gene transfer, also known as gene therapy, developed collaboratively by the National Institutes of Health (NIH) and the FDA.
Patients, research participants, scientists, sponsors, and others can become better informed about human gene transfer research by using GeMCRIS. Through drop-down menus and preformatted reports, people can easily navigate the GeMCRIS site to learn where trials are taking place, which diseases or health conditions are being studied, and what investigational approaches are being taken. And GeMCRIS includes special security features to protect patient privacy and confidential commercial information.
The new system will also serve as an electronic tool to help researchers report and analyze adverse events that occur in human gene therapy trials, improving the government's ability to monitor this research area. Investigators and sponsors conducting human gene transfer trials will be able to submit adverse event reports to the NIH and the FDA using a secure electronic interface on the GeMCRIS system. This will allow both agencies to improve safety oversight in human gene transfer trials through the harmonization of NIH and FDA reporting requirements.
The Centers for Disease Control and Prevention (CDC) has recommended that children who are 6 months to 23 months of age get vaccinated annually against the flu (influenza). This recommendation, which will be in effect for the 2004-2005 influenza season, comes from the Advisory Committee on Immunization Practices, a panel of experts that advises the CDC on issues related to vaccines.
Studies have shown that infants and children younger than 2 years old are at increased risk for flu-related hospitalizations. Preliminary reports from the 2003-2004 flu season indicate that among 143 deaths in children due to the flu, 58 occurred in children younger than 2.
Two doses of inactivated flu vaccine given more than one month apart are recommended for previously unvaccinated children younger than 9. If possible, the second dose should be administered before December of each year. All subsequent annual flu vaccinations require only one dose of vaccine.
In addition to children younger than 2, the recommendations advise that family members and other close contacts of children up to 23 months old receive a flu vaccination. Flu vaccination is not recommended for children younger than 6 months because there are no flu vaccines licensed for use in this age group. The current inactivated flu vaccines are approved for use in children 6 months of age and older. FluMist (influenza virus vaccine live, intranasal), which is sprayed into both nostrils, is not approved for use in children younger than 5.
To ensure that women and health professionals have the most current and complete information available when taking or prescribing Zelnorm (tegaserod maleate) for short-term treatment of irritable bowel syndrome (IBS), the FDA has revised the drug's labeling to include new risk information.
The revisions include:
Made by Novartis Pharmaceuticals Corp. of East Hanover, N.J., Zelnorm increases the movement of stools through the bowels. The drug does not cure IBS, nor does it treat diarrhea-prominent IBS. Rather, it reduces bloating and constipation. Zelnorm should not be taken by women who are currently experiencing or frequently experience diarrhea. Its safety and effectiveness in men is not established.
Some Mexican candy sold in the United States has been associated with lead contamination, and the FDA is advising that it would be prudent to not allow children to eat these products. The health effects of elevated lead levels in children are well documented and can result in learning deficiencies and delayed mental and physical development.
The FDA has compiled information indicating that candy containing significant amounts of chili powder may contain higher lead levels than other types of candy, such as candy that contains predominantly sugar. Examples of chili-containing products include lollipops coated with chili and chili seasoning sold in packets as a snack item. The FDA believes that contamination of chili powder may be occurring at certain steps in the manufacturing process.
Also, tamarind, a popular Mexican candy item, can become contaminated with lead if it is sold in poorly made glazed ceramic vessels that release lead from the glaze into the candy.
The FDA will be working with Mexican government and industry personnel on this issue and plans to establish more stringent guidance for considering regulatory action against candy containing lead.
The FDA has approved the first effective treatment for people with a collection of disorders called myelodysplastic syndrome (MDS), in which bone marrow does not function normally. Genetic abnormalities in people with the syndrome prevent bone marrow cells from maturing, and too many abnormal blood cells are made. Vidaza (azacitidine) injection, approved in May 2004, is thought to work by causing immature, abnormal bone marrow cells to become more mature, resembling normal cells.
The most common side effects of Vidaza reported in clinical trials include nausea, anemia, low platelets in the blood, diarrhea, fatigue, irritation at the injection site, and constipation.
MDS may develop without any known cause or following treatment with drugs or radiation therapy for other diseases. Some forms of MDS can progress to acute myeloid leukemia (AML), a type of cancer in which too many white blood cells are made.
It is estimated that 7,000 to 12,000 new cases of MDS are diagnosed each year in the United States. Though the disease can occur in all age groups, it occurs most often in people over 60. Typical symptoms include weakness, fatigue, infections, easy bruising, bleeding, and fever.
The sponsor and distributor of Vidaza is Pharmion Corp. of Boulder, Colo.
A final rule announced in May 2004 allows the FDA to detain food articles, under the authority of the Bioterrorism Act of 2002, if they present a threat of serious health problems or death. Under the rule, the agency may detain food for up to 30 days on the strength of credible evidence or information resulting from an inspection, examination, or investigation. This rule is part of the FDA's continuing effort to ensure the safety and security of the nation's food supply.
"Identifying and removing contaminated food from the food supply is an essential part of responding to terrorist acts," says Dr. Lester M. Crawford, Acting FDA Commissioner. "This rule describes how the FDA can hold food in place while it initiates legal action in court to seize it and permanently remove it from commerce. Alternately, our experts can determine that the food is safe, and the detention order may be terminated. Either way, consumers are protected."
FDA's fact sheet on the final rule.
An Alabama physician has been sentenced to 57 months in prison after pleading guilty to mail fraud.
Ann Campbell, 46, of Gadsden, Ala., was an investigator conducting a clinical trial for a new antibiotic drug when she falsified data related to the number of people in the study. She then sent the false data to Aventis Pharmaceuticals Inc., the company that sponsored the study. The FDA was able to approve the drug, Ketek, using other available data.
In addition to receiving a jail sentence in March 2004, Campbell was fined $557,251.22 and was given three years supervised release after the prison term is served. Additionally, Campbell was ordered to make restitution to Aventis in the amount of $925,774.61.
Campbell entered her guilty plea to the charge on Oct. 23, 2003. The case was investigated by the FDA's Office of Criminal Investigations and was prosecuted by Assistant U.S. Attorney Herbert H. Henry.