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The FDA is warning consumers not to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide, a drug that could have serious, life-threatening consequences for some people. Liqiang 4 has also been called Liqiang Xiao Ke Ling--Liqiang Thirst Quenching Efficacious--in ads in Chinese language publications. The ads promote the substance as being derived from only natural ingredients and as being useful for controlling diabetes.
Glyburide, a drug used to lower blood sugar, is safe and effective when used as labeled in FDA-approved medications. But people who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using this product and seek medical attention, especially if they are being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities. Consumers who have this product should dispose of it immediately.
The FDA learned of the potential problem through an anonymous consumer complaint, and followed up with testing that revealed the presence of glyburide in Liqiang 4. The product is sold as part of a shrink-wrapped two-bottle set. One of the 90-capsule bottles is labeled Liqiang 4 Dietary Supplement Capsules, and the other bottle is promoted as a "bonus pack" of Liqiang 1. The FDA is evaluating Liqiang 1 and other versions of this line of products to determine their composition and safety.
The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge, Calif.
The FDA encourages consumers, health professionals, and caregivers to report adverse events related to this product to MedWatch, the agency's voluntary reporting program. Phone: (800) FDA-1088; Fax: (800) FDA-0178; Online: www.fda.gov/medwatch/report.htm; or Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20857-9787.
The FDA approved updated labeling for the erectile dysfunction drugs Cialis (tadalafil), Levitra (vardenafil hydrochloride), and Viagra (sildenafil citrate) to reflect a small number of sudden vision-loss cases reported after the drugs were marketed. The vision loss in the reports was attributed to a condition called non-arteritic ischemic optic neuropathy (NAION), in which blood flow is blocked to the optic nerve.
The FDA says it is not possible to determine whether these oral erectile dysfunction drugs were the cause of the loss of eyesight or whether the problem is related to other factors. The agency, however, advises patients to stop taking these medicines and to call a doctor immediately if they experience sudden or decreased vision loss in one or both eyes. In addition, those who use or who are considering using the products should tell their health care professionals whether they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk for developing NAION again.
Baxter Healthcare Corp. of Deerfield, Ill., has recalled all models of its Colleague Volumetric Infusion Pumps worldwide because they can shut down while delivering critical medication and fluids to patients. The FDA has determined that this action is a Class I recall. Class I is the most serious type of recall and involves situations in which there is a reasonable probability that use of the affected product will cause serious injury or death. The affected pumps are Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
"Given the widespread use of these pumps and the multiple failure modes, FDA is quickly informing users of this important safety issue," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "We will continue to monitor the situation closely and inform the public immediately of any new developments."
Baxter has stopped shipping the pumps until the problems are resolved. The firm also has advised customers to stop using any pumps that show a failure code beginning with 402, 403, 533, 535, 599, 810:04, or 810:11 until they are inspected by authorized service personnel.
In addition to the shut-down problem, the device may exhibit two additional failure modes:
At this time, users should not return the pumps to Baxter. See www.Baxter.com for more information. Consumers who have questions about the recall may contact Baxter Healthcare at (800) 422-9837; for technical questions, call Baxter at (800) THE-PUMP (843-7867).
If you are a physician or a patient who has experienced a problem with any of these infusion pumps, please send a report to the FDA's MedWatch program and to Baxter. See www.fda.gov/medwatch/ or call (800) FDA-1088 (332-1088).
The FDA has tentatively approved several generic AIDS drugs under a relief plan intended to target prevention, treatment, and care programs to countries that are among the most afflicted by the disease.
Since June 2005, a half dozen drug applications have received tentative FDA approval, meaning that the products will now be available for consideration for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR). The plan, which President Bush first announced in his 2003 State of the Union Address, is providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries. The PEPFAR plan is designed to prevent 7 million new HIV infections, treat at least 2 million HIV-infected people, and care for 10 million people infected and affected by HIV/AIDS, including orphans and other children who are vulnerable.
The FDA's tentative approval of these drugs means that although existing patents and exclusivity prevent them from being marketed in the United States, the drugs meet all the FDA's quality, safety, and effectiveness standards required for marketing in this country. See www.fda.gov/oashi/aids/hiv.html for more information on HIV/AIDS and the drugs used to treat the disease.
With the coming of fall and the "cider season," the FDA is reminding consumers about the risks of drinking juice and cider that has not been treated through pasteurization or other means to ensure its safety. When fruits and vegetables are made into juice, harmful bacteria which may be present on the produce can become part of the juice. Unless the juice is pasteurized or otherwise treated, the bacteria may cause serious and even fatal illness in consumers. Young children, the elderly and persons with weakened immune systems have the highest risk of contracting illness. Parents, school officials, and children's activity leaders need to be aware of this.
When purchasing juice in a store it is easy to tell if it has been treated for safety. Untreated packaged juice products are required to bear the following label: WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems. However, not all juice comes from a retail store. School officials and others often take children to farms and orchards for fall activities. Untreated cider may be served by the glass at these activities. No warning signs or labels are required for juice served by the glass. Therefore, FDA recommends that, when you plan such activities, you ask if untreated juice or cider is served at the location, and if it is avoid giving it to children. Fruit and vegetable juices and cider are nutritious, healthful beverages as long as they are pasteurized or otherwise treated to kill harmful bacteria. By following these recommendations, fall activities can be safe as well as fun.
The FDA has issued a public health advisory on use of the transdermal fentanyl patch in response to reports of deaths in patients using this potent narcotic medication for pain management. A patient information sheet and an alert to health care professionals also were issued identifying several important safety precautions for using the patch.
These safety precautions include patient education regarding signs of overdose, proper patch application, use of other medications while wearing the patch, safeguards for children, and proper storage and disposal.
The FDA is conducting an investigation into the deaths associated with the product, and is trying to determine whether reported adverse events may be related either to inappropriate use of the patch or to factors related to the quality of the product.
The agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.
The Centers for Disease Control and Prevention recommends routine vaccination with Menactra, the newly licensed meningococcal conjugate vaccine for children ages 11 to 12, for previously unvaccinated adolescents at high school entry at about age 15, and for college freshmen living in dormitories.
The new recommendation is designed to help achieve vaccination among those at highest risk for meningococcal disease, which strikes up to 3,000 Americans, killing 300 people every year. Ten to 12 percent of people with meningococcal disease die, and among survivors, up to 15 percent may suffer long-term permanent disabilities including hearing loss, limb amputation, or brain damage.
The disease often begins with symptoms that can be mistaken for the flu and other common illnesses. But meningococcal disease is particularly dangerous because it progresses rapidly and can kill within hours.
Menactra should offer longer protection than previous vaccines. It is given in a single shot, and the most common reaction is a sore arm. But it does not protect people against meningococcal disease caused by serogroup B bacteria, which causes one-third of meningococcal cases in the United States.
Menactra was licensed by the FDA in January 2005 for use in people ages 11 to 55. The vaccine is manufactured by Sanofi Pasteur, a division of Paris-based Sanofi-Aventis. Visit www.cdc.gov/ncidod/dbmd/diseaseinfo/meningococcal_g.htm for more information.
The FDA is investigating recently reported serious adverse events associated with Mifeprex (mifepristone), also known as RU-486. As a result, the FDA has issued a public health advisory highlighting the risk of sepsis, or blood infection, when undergoing a medical abortion using Mifeprex and misoprostol in a manner that is not consistent with the approved labeling. There are now four cases of deaths from infection from September 2003 to June 2005 after a medical abortion with these drugs.
The bacteria thought to have caused the fatal infection have been identified in two of the cases, and the other two cases are under investigation by the FDA, along with the Centers for Disease Control and Prevention, state and local health departments, and Danco Laboratories LLC, the manufacturer of Mifeprex. Doctors are urged to have a higher level of suspicion for sepsis in their patients taking Mifeprex.
Previously, the FDA had received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death. Those reports led to the revision of the black box labeling for Mifeprex, approved by the FDA in 2000. The drug is approved as part of a regimen that calls for at least three visits to a doctor's office or clinic, according to the labeling. On the first visit, the woman receives counseling and a medication guide. Then she takes 600 milligrams of mifepristone by mouth while at the doctor's office. Two days later, she returns to the physician and, if she is still pregnant, takes 400 micrograms of misoprostol by mouth while in the doctor's office. Misoprostol, a prostaglandin, causes the uterine muscles to contract and end the pregnancy.
"The FDA is committed to sharing emerging drug information with the public and we believe it is important to share with health care providers and patients the latest serious reports of infection associated with this drug that we have received," says Steven Galson, M.D., Director of the FDA's Center for Drug Evaluation and Research.
Visit www.fda.gov/cder/drug/infopage/mifepristone for more information.
The FDA has approved Aptivus (tipranavir) capsules to be given with ritonavir for the treatment of adults infected with HIV-1, the virus that causes AIDS. Aptivus, approved in June 2005, is the second drug approved for people with advanced HIV disease and provides a new therapy for those with limited treatment options.
When used together with ritonavir, Aptivus was shown to be an effective treatment for patients who had already used many HIV medicines and who had a type of virus resistant to available anti-HIV medicines. Taking 200 milligrams of ritonavir twice daily was shown to boost the level of Aptivus, and lowered the amount of virus in the blood more than other anti-HIV medicines.
The labeling for Aptivus includes a black box warning indicating that the drug can cause serious liver problems, especially in patients with liver disease. Other adverse events seen in clinical trials include higher cholesterol and triglyceride levels and skin rashes. The rashes were seen more often in women who are HIV-positive when compared with men who are HIV-positive.
Because of potential drug interactions, patients using Aptivus with low-dose ritonavir should tell their doctors about the use of any other prescription drug, nonprescription drug, or herbal products, particularly St. John's wort. Certain medicines should never be given to people taking Aptivus plus ritonavir because serious side effects can occur. These include medicines that treat irregular heart beats (antiarrhythmic), antihistamines, ergot derivatives that are found in some medicines to treat migraine headaches, medicines that speed up the digestive tract, herbal products, some medicines that lower cholesterol levels, and medicines that treat mental problems.
Boehringer Ingelheim Pharmaceuticals Inc., the manufacturer of Aptivus, will conduct additional post-marketing studies. These studies will evaluate drug-drug interactions and how Aptivus works in other patient groups, such as those taking HIV medicines for the first time, children, and women who are HIV-1 positive.
The FDA is alerting parents to the danger of human disease from small turtles, which are illegal as pets. Small turtles are a source of salmonellosis, an infection of the intestines caused by bacteria called Salmonella.
Symptoms of salmonellosis may include diarrhea, stomach pain, nausea, vomiting, fever, and headache. Symptoms begin in six to 72 hours after a person is exposed to Salmonella, and they generally last for two to seven days. Salmonella, which occur naturally in turtles, usually do not make them sick.
Anyone can get salmonellosis, but the risk is highest in infants and young children, older people, and others with weakened immune systems.
The sale of turtles with a shell (carapace) length less than four inches has been banned in the United States since 1975 because of the public health impact of turtle-associated salmonellosis. The FDA enforces this regulation in cooperation with state and local health jurisdictions. Experts estimate that the regulation has prevented about 100,000 cases of salmonellosis a year; however, there has been an increase in the sale of turtles in recent years.
The FDA urges parents and others responsible for the care of children to be alert for any turtles in petting zoos, parks, child day care facilities, or other locations. People who come in contact with turtles or their housing should wash their hands thoroughly with soap and water.
The FDA has approved a new vaccine for adolescents and adults that provides a single booster immunization against whooping cough (pertussis) in combination with tetanus and diphtheria.
Approved in June 2005, Adacel, a tetanus toxoid (T), reduced diphtheria toxoid (d), and acellular pertussis vaccine (ap) absorbed, is marketed by Aventis Pasteur Ltd. of Toronto. Adacel contains the same components as Daptacel, a DTaP vaccine for infants and children manufactured by Aventis Pasteur Ltd., but the diphtheria toxoid and one of the pertussis components are in reduced quantities. Adacel is indicated for use as a single booster dose to adolescents and adults ages 11 to 64.
The FDA approved a similar vaccine called Boostrix, manufactured by GlaxoSmithKline of Philadelphia, for use in adolescents ages 10 to 18.
Whooping cough is a highly contagious and potentially serious illness that can cause prolonged cough. In infants, it is more frequently severe and can be fatal, particularly in those too young to be fully vaccinated. Since 1980, the rates of reported whooping cough cases have been increasing in adolescents and adults, as well as in infants. Adolescents and adults have been implicated as the source of pertussis infection for other susceptible family members.
The FDA is making significant progress in its fight against counterfeit drugs. In its annual update to a report called "Combating Counterfeit Drugs," the FDA says its Office of Criminal Investigations initiated 58 counterfeit drug investigations involving hundreds of thousands of fake dosage units during 2004. These cases represent a dramatic increase from the previous year when 30 such cases were initiated.
The increase is partially due to heightened vigilance and awareness by all parties in the drug distribution system as a result of the FDA's original report, issued in February 2004. More effective coordination with other state, federal, and foreign law enforcement agencies, and improved communication with drug manufacturers, also contributed to the increase in investigations.
"This year's report illustrates how our Special Agents within the FDA's Office of Criminal Investigations are showing criminals that if you counterfeit drugs, the FDA will catch you," says Margaret O'K. Glavin, the FDA's Associate Commissioner for Regulatory Affairs.
In the last year, there has also been tremendous progress with the development and implementation of a standard electronic track and trace system using radio-frequency identification for widespread use in the drug distribution system. Significant advances are also being made in developing an electronic pedigree for drug products. The FDA is optimistic that this progress will continue at a rapid pace and will achieve widespread use in the drug supply chain. These changes will make it more difficult for counterfeit drugs to enter the distribution system.
Also, drug manufacturers are increasing their use of anti-counterfeiting technologies such as holograms, color-shifting inks, and covert markings on drug products and packaging. And several states are beginning to adopt stricter laws regarding the movement of drugs through the supply chain.
The FDA is pursuing several initiatives to further protect the safety and integrity of the U.S. drug supply. These initiatives include strengthening ties with foreign law enforcement agencies and international organizations, and informing the public about the risks of counterfeit drugs through a new consumer education program.
"We believe the United States prescription drug supply is as safe as any in the world, and the FDA is committed to ensuring that this continues," says Randall Lutter, the FDA's Acting Associate Commissioner for Policy and Planning.
For more information on counterfeit drugs, visit the National Consumers League's Web site at http://fraud.org/fakedrugs/
To access the latest report, "Combating Counterfeit Drugs Annual Update," May 2005, visit www.fda.gov/oc/initiatives/counterfeit/update2005.html
The original report, "Combating Counterfeit Drugs," is at www.fda.gov/oc/initiatives/counterfeit/report02_04.html
The FDA has asked Purdue Pharma L.P. of Stamford, Conn., to withdraw the pain drug Palladone (hydromorphone) from the market after the agency acquired new information indicating that potentially fatal adverse reactions can occur when Palladone extended-release capsules are taken with alcohol.
Palladone is a once-a-day pain management drug containing a very potent narcotic. New data from a company-sponsored study testing the potential effects of alcohol use show that when Palladone is taken with alcohol, the extended-release mechanism is harmed, which can lead to dose-dumping. Dose-dumping is a term that describes the rapid release of the active ingredient from an extended-release product into the bloodstream.
The consequences of dose-dumping at the lowest marketed dose--12 milligrams--of Palladone could lead to serious, or even fatal, adverse events in some patients. The risk is even greater for the higher strengths of the product. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the United States, pending further discussions with the agency.
"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk," says Steven Galson, M.D., Director of the FDA's Center for Drug Evaluation and Research. "Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications."
The current labeling for Palladone, approved in September 2004, already includes the standard opioid warning against the use of alcohol and Palladone. But the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and by a risk management plan.
People who currently take Palladone should consult with their physicians for alternative treatments. See www.fda.gov/cder/drug/infopage/palladone/default.htm for more information.
The source for the chart on page 36 of the July-August 2005 issue titled “Examples of Error-Prone Drug Information” is the Institute for Safe Medication Practices.