Show #42, August 2005
Show #42, August 2005
|New Vaccines for Pertussis in Teens and Adults|
FDA recently approved two new vaccines that provide a booster immunization against whooping cough, in combination with tetanus and diphtheria immunization. One is called Boostrix and the other is Adacel.
Boostrix is approved for use in adolescents age 10 - 18 and it's made by GlaxoSmithKline. Adacel is approved for adolescents and adults up to 64 years of age. It will be distributed by Aventis Pasteur. These two new vaccines are the first ones approved for use in adolescents and adults.
Since 1980, the rates of reported pertussis cases have been increasing in adolescents and adults, as well as in young infants. Pertussis can be especially serious or possibly even fatal in these very young infants. So part of the rationale for immunizing adolescents and adults is to make it less likely that they'll transmit the disease to infants. In other words, older people would be immunized to protect children.
- Product Approval Information – Licensing Action - Boostrix®.
- Product Approval Information – Licensing Action - ADACEL™.
|New Drug for Restless Legs Syndrome|
The FDA recently approved a drug called Requip (ropinorole) to treat moderate to severe restless legs syndrome (RLS), a neurologic disorder characterized by uncomfortable sensations in the legs that appear at rest, usually at night, and that induces a strong desire to move the legs. This can result in chronic insomnia and sleep deprivation. Requip is manufactured by GlaxoSmithKline. The drug is a dopamine agonist and it was first approved in 1997 to treat Parkinson's disease.
Requip was found to be effective in treating RLS in three randomized, double-blind, placebo-controlled studies. The label for the drug will caution that Requip can have sedating effects, and that syncope and symptomatic hypotension can occur, especially during initial treatment.
|Certain Guidant Implantable Defibrillators Recalled|
Guidant Corporation is recalling certain models of the company's implantable defibrillators and cardiac resynchronization therapy devices. Several different problems have led to these actions.
The first problem applies to three device models: THE PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002; THE CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004; and THE CONTAK RENEWAL 2, Model H155, also manufactured on or before August 26, 2004. These devices can develop an internal short circuit without warning, which can result in failure to deliver a shock during periods of arrhythmia.
In a second action, Guidant has also notified physicians and patients about a possible component failure in a different set of defibrillators. The affected devices are the CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF. A magnetic switch in these devices may become stuck in the closed position, and that may inhibit the device's ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.
In a third action, Guidant has notified physicians that certain implants with atrial therapy capability may experience a memory error that could limit available therapy. The affected devices are the PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT.
- FDA MedWatch Safety Alert 2005 - Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators.
- Guidant Corp Physician Communications.
|Update on the Potential Dangers of Using Vail Enclosed Bed Systems|
FDA has updated its notification that warned about using Vail enclosed bed systems, models 500, 1000 and 2000. These beds were designed as an alternative to restraints for patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders.
But using the beds poses a public health risk because patients can become entrapped and suffocate. FDA is aware of approximately 30 reports of entrapments, falls and other incidents with the beds, including at least 8 deaths. More than half of these incidents involved children 16 and under.
Vail Products, Inc. has now publicly stated that it is permanently ceasing the manufacture, sale and distribution of these beds, and will no longer be able to provide accessories, replacement parts, or retrofit kits. The company mailed revised instruction manuals and warning labels to its direct customers and distributors.
FDA's advice to hospitals and nursing homes that have Vail enclosed bed systems remains the same: stop using them and move patients to alternative beds. Consumers using these beds at home should consult with their physicians about other options.
If continuing to use the Vail enclosed bed system is the only option, it's very important to follow the safety precautions recommended in the company's mailing in order to minimize the risk of entrapment or falls. It's especially important to note that the company now contraindicates the beds for patients who weigh less than 46 pounds or who are less than 45 inches in height.
- FDA Preliminary Public Health Notification: Vail Products Enclosed Bed Systems.
- FDA Press Release - FDA Notifies Public that Vail Products, Inc., Issues Nationwide Recall of Enclosed Bed Systems.
|Sustiva and Neural Tube Defects|
Bristol-Myers Squibb and FDA are notifying healthcare professionals about the possibility of neural tube defects when Sustiva (efavirenz) is given to women in the first trimester of pregnancy. This drug is used to treat HIV-1 infection.
The company's letter notes that the pregnancy category for Sustiva has been changed to Category D, “Positive Evidence of Fetal Risk.” This is based on four reports of neural tube defects in infants born to women who were exposed to the drug during the first trimester.
The letter goes on to warn that pregnancy should be avoided in women receiving Sustiva. It recommends that women of childbearing age undergo pregnancy testing before receiving the drug, and that if a woman becomes pregnant while on Sustiva, she should be told of the potential risk to the fetus. The letter says that Sustiva should be used during the first trimester only if the potential benefit outweighs the risk to the fetus, such as in women with HIV who have no other therapeutic options.
|Nationwide Recall of Drugs Made by Able Laboratories|
FDA is notifying health care professionals and consumers about a nationwide recall of all drugs manufactured by Able Laboratories of Cranbury, NJ. Able Laboratories makes mostly generic prescription drugs, including drugs containing acetaminophen.
The drugs are being recalled because of serious concerns that they weren't produced according to quality assurance standards. The company has stopped all current production.
Patients who have been taking drugs produced by Able Laboratories should continue taking their medications until they've spoken to their doctor or pharmacist to get a replacement drug.
|Updated Mortality Information for Natrecor|
In a recent letter, Scios, Inc. notified health professionals about newly published reports on the safety of the drug Natrecor (nesiritide) which is used to treat acutely decompensated congestive heart failure. The reports raise the question of whether Natrecor may have adverse effects on survival and kidney function compared with standard medications such as nitroglycerin and diuretics.
Scios has changed the “Important Safety Information” section of the labeling for Natrecor to describe the mortality data more fully. The company also convened an expert panel to review and analyze the safety data. The panel made several recommendations on the use of the drug, what information to provide to health care professionals, and obtaining further safety data.
|Buying Medicines Safely over the Internet|
Many patients are now buying medicines and medical products on line. This can be convenient way to shop, but unless people are very careful, getting medicines on line can be a hazardous proposition. The FDA has a new brochure that can help guide people safely through the process. It's called “Buying Prescription Medicine Online: a Consumer Safety Guide."
There are documented cases where drugs bought on the Internet were fake, or substandard in potency, or unapproved by the FDA, or counterfeits of approved drugs, or just plain dangerous.
For example, in 2001, soon after the anthrax contamination incident in a Washington postal center, there was great demand for the drug Cipro. Fearing an anthrax attack, many people tried to purchase the drug and stockpile it. To satisfy that demand, Cipro - or products claiming to be Cipro - were suddenly offered on foreign web sites. There was no way of knowing whether what was being sold was manufactured properly, or even whether it was actually Cipro.
For a later example, earlier this year, FDA warned consumers not to use a wide variety of home diagnostic kits which had not been reviewed or approved by FDA. The kits, sold on the Internet by a company called Globus Media, included home tests for pregnancy, syphilis and HIV. Again, there was no way to know whether these kits actually worked, and the manufacturer wasn't even identified in the packaging. So people could be testing themselves for HIV and getting erroneous results - and that could be tragic in many ways.
The new brochure advises people to be sure to buy from a reputable site. To help do this, they should be sure the site is licensed by a State Board of Pharmacy. Some sites display a so-called “VIPPS® seal” (Verified Internet Pharmacy Practice Sites™ Seal), which shows that they meet State and federal rules. And consumers should be sure the site has a registered pharmacist to answer questions.
|Alert on Certain Children's Tylenol Products|
McNeil Specialty Pharmaceuticals is alerting consumers and healthcare professionals about certain children's Tylenol products because the packaging is potentially confusing. This could lead to children getting the wrong dose, including a possible overdose.
The affected products include all lots and all flavors of Children's TYLENOL Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOL SoftChews 80mg packaged in blisters, and Junior TYLENOL Meltaways 160mg packaged in blisters. There are two ways that confusion might arise.
The first concerns the way the individual tablets are packaged and labeled. Each tablet of Children's Tylenol Meltaways and SoftChews contains 80 mg of acetaminophen. Some of the blister cavities contain one of these 80 mg tablets, and some contain two. This allows parents to adjust their child's dose by selecting the correct number of individual tablets, using the dosing chart on the carton.
The confusion arises because the back of the two-tablet blister cavity is labeled "80 mg," which is intended to mean that each of the two tablets in the blister contains 80 mg. But consumers may interpret this to mean that the two tablets in the blister taken together contain 80 mg. And that could lead to accidentally doubling the child's dose. To resolve the confusion, the company is removing these Tylenol products from store shelves and correcting the way they're labeled.
The second possible source of confusion is the way the carton is labeled. The carton for some Children's Tylenol Meltaways and the Junior Tylenol Meltaways identifies the product strength as "medicine per dose" rather than "medicine per tablet". The company has proposed to change the labeling on the cartons to clear up the possible confusion. In the meantime, given the possibility of an acetaminophen overdose, it's important to remind parents that the labeled strength of acetaminophen in these products is per tablet. They should be sure to follow the dose directions in the "Drug Facts" labeling to determine the correct number of individual tablets to be given per dose, based on the child's age and weight.
- ISMP Medication Safety Alert - Unsafe Tylenol packaging.
- McNeil Consumer & Specialty Pharmaceuticals – Tylenol.
- FDA MedWatch Safety Alert 2005 - Recall of Children's Tylenol
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