WASHINGTON (MarketWatch) -- A Food and Drug Administration panel is set to meet Thursday to discuss the safety review of 16 drugs, including flu drug Tamiflu, in pediatric patients.
The pediatric advisory committee will evaluate new and updated reports by the FDA staff that include information on the drugs' safety compiled over a year. The panel will then make recommendations that could include label changes or further investigation of adverse events.
The FDA isn't required to follow the panel's suggestions, but it usually does.
Although the panel was to issue an opinion on Tamiflu's label Thursday, on Tuesday its manufacturer, Roche Holding AG (RHHBY), said it would follow the FDA staff's recommendation in the report and update the label to warn patients of potential abnormal behavior during treatment, including delirium and hallucinations.
In its report, the staff said the label should be changed following a review that found 103 cases of "neuropsychiatric adverse events," including the death of a 14-year-old boy who fell after climbing on his condominium balcony's railing.
According to documents posted on the FDA Web site ahead of Thursday's meeting, eight drugs under review didn't raise any safety concerns. They include cholesterol-lowering medications Lipitor from Pfizer Inc. (PFE) and Zocor from Merck & Co. (MRK), Eli Lilly & Co.'s (LLY) cancer drug Gemzar, and Johnson & Johnson's (JNJ) Ditropan to treat bladder instability.
The other eight drugs either presented new unlabeled safety concerns or "other attributes," including labeled but "serious adverse events of interest" and past safety concerns, the FDA said.
Included in this group are Pfizer's Zyvox, GlaxoSmithKline PLC's (GSK) Zofran and Avandia, Forest Laboratories Inc.'s (FRX) Celexa, Novartis AG's (NVS) Trileptal, Wyeth's (WYE) Rapamune and Abbott Laboratories' (ABT) Norvir.
In an updated report for depression drug Celexa, the FDA staff identified three new cases associated with QT prolongation, which can cause a fatal arrhythmia, since August 2003. The FDA requested the review following a prior report that found a possible association between the drug and the problem in all ages.
"However, this updated review of three new cases...didn't find any well-documented cases of QT prolongation associated with using regular doses of (Celexa) in pediatric patients," the FDA staff concluded.
On Pfizer's Zyvox, which is indicated for treatment of certain bacterial infections, the FDA staff found six unlabeled events of "cardiac nature" during the one-year review. The report, however, said the cases "cannot be definitively associated" with the drug.
In the report on epilepsy drug Trileptal, the FDA staff recorded 84 adverse events in children taking the drug in the year-long review. Those events included one death, 52 unlabeled and 31 labeled cases. The staff said the unlabeled cases were too few to "characterize any one adverse event as a potential safety signal."
On Wyeth's Rapamune, the investigation found 19 pediatric cases of adverse events, including two reports of fluid collection that develops between the lining of the heart and the heart itself, and one report of cerebral bleeding.
Rapamune is indicated for the prophylaxis of organ rejection in patients ages 13 or older receiving a renal transplant. The FDA staff, however, said the majority of children it studied were under 12 years of age.
The report found it was "premature" to determine if the drug "played a clear role" in the adverse events reported.
On Glaxo's Zofran, used to prevent nausea and vomiting associated with chemotherapy and radiotherapy for cancer, the FDA staff identified 20 adverse events over a year, including one death. The report said, however, that most patients had underlying conditions or were taking other medication, making it difficult to link the events to the use of Zofran.
In the review of diabetes drug Avandia, the staff found two adverse cases during the one-year period, one involving accidental ingestion and the other involving behavioral changes. It said there were too few reported events to draw any safety conclusion.
On Abbott Labs' Norvir, used to treat HIV patients, the review found 33 adverse events in children in a period of one year, including skin reactions, anemia and pancreatitis. There were three deaths, none directly related to the use of the drug, the FDA said, adding it didn't find any safety concerns.
In the reports, the staff said it will continue to monitor adverse events related to the drugs. The FDA panel will meet at the agency's headquarters in Rockville, Md.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
In the past year, Pfizer has successfully tagged more than 2 million bottles, 55,000 cases and 400 pallets of Viagra. Now, the drug manufacturer is ready to start tagging another of its top-selling drugs: Celebrex.
In 2007, Pfizer plans to affix UHF Gen 2 RFID tags to all cases and pallets of the drug—a pain reliever and anti-inflammatory—bound for the U.S. market. This is part of an effort to expand the scope of Pfizer's RFID initiative, the drugmaker announced at this week's RFID Health-Care Industry Adoption Summit conference in Washington, D.C. The Celebrex trial will require Pfizer to build out its RFID infrastructure and expertise beyond its plant in France, which produces and packages Viagra, to a much larger plant in Caguas, Puerto Rico.
The initiative will incorporate four assembly lines used to produce and package Celebrex, each of which operate at a speed four times that of a Viagra line. The expansion will enable Pfizer and its trading partners to vet findings established in the past year with the Viagra RFID project. For example, says Byron Bond, director of trade operations and customer service for Pfizer's U.S. pharmaceuticals division, the Celebrex pilot will provide the drugmaker a more accurate picture of tag read rates, which have thus far proven very high in the Viagra trial, involving only one product and one assembly line.
"This will be a little more challenging environment," Bond says. "The higher volumes will help us validate what we've learned and better understand RFID's costs. Celebrex has significant volumes, so for [distributors], as well as us here at Pfizer, who really want to look at operational efficiencies, we'll all be able to get a clearer picture."
Celebrex's annual volumes are significantly higher than Viagra's and, therefore, more costly to tag. As such, Pfizer has opted not to tag at the unit level. Moreover, tagging cases and pallets of Celebrex will allow the manufacturer to test the concept of case-level serialization and authentication, which could help wholesalers identify counterfeit drugs. "I'm not going to tell you we're convinced that case-level validation is the only solution, but it can enable systemic counterfeit detection," Bond says. "You don't always have to go to the expense of item-level tagging."
Labels: No Prescription, Online Pharmacy, Prescription Drugs
The high cost of prescription drugs has everyone looking for ways to save. Hospitals, HMOs and insurance plans are as upset about their pharmacy bills as individual patients are.
One popular solution is to buy generic drugs. Doctors are encouraged to prescribe generic equivalents when possible. Patients may be penalized if they insist on a brand name. The co-pay for branded medications is often double or triple that for generics.
People without insurance often can't afford anything other than generic medicine. How good are these substitutes?
For 30 years we have defended generic drugs. The Food and Drug Administration assured us that its rigorous standards ensured quality. A few years ago, however, we started to get reports from readers about generic-drug failures.
Some parents claimed that when a child with ADHD was shifted from Ritalin to generic methylphenidate, his behavior and attention deteriorated. Patients whose epilepsy was well controlled on the anticonvulsant Dilantin reported seizures when switched to generic phenytoin.
An article in the journal Neurology (Oct. 26, 2004) confirmed that some generic phenytoin did not perform up to standards. The neurologists reported breakthrough seizures in patients under good control for years.
We also heard from people who had problems with irregular heartbeats, hypertension, acid reflux or pain when they were switched. Many found the generic version of their medication seemed less effective than the original.
We were puzzled by this spate of reported problems with generic medicines, so we contacted the FDA to find out how the agency monitors the quality of drugs after they are approved. We were not reassured by what we learned.
As far as we can tell, the pharmaceutical marketplace in the U.S. works on the honor system. The FDA relies on drug companies to be honest.
For such a profitable industry, there is remarkably little oversight. Airplanes, elevators and even restaurants are inspected on a regular basis. But more than 3 billion bottles of pills are dispensed in the U.S. each year, and only a relative handful are actually tested. The FDA says it pulls about 300 pill bottles off shelves to test for content and dosage strength. This amounts to 1 in 10 million.
Where do ingredients for generic drugs come from? More and more often, countries like China and India are getting into the game. The competitive nature of the generic-drug market makes low-cost source materials very attractive. Without constant quality surveillance, we worry that U.S. consumers may not always be getting what they expect.
We have examined the controversy over generic drugs in much greater depth in our new book, Best Choices From The People's Pharmacy (Rodale Books). It offers guidelines for using generic drugs safely. Tips include:
• Record numbers (blood pressure, blood sugar, etc.) that show if the drug is working.
• Monitor lab results (cholesterol, thyroid, INR).
• Observe your subjective response to antidepressants, pain medicine or sleeping pills.
With care, you can use generic drugs safely. If you suspect your medicine is not working properly, notify your doctor immediately. Switching back to the brand name might cost more, but it could preserve your health.
THE PEOPLE'S PHARMACY
Q. I have taken both Viagra and Cialis. They work well, but I do get sinus-pressure headaches when I take these drugs. I feel this has contributed to sinus infections that have required lengthy courses of antibiotics. Is this possible?
A. Nasal stuffiness is a relatively common reaction to drugs for erectile dysfunction like Viagra, Cialis and Levitra. People who experience chronic congestion may develop an infection and sinusitis as a consequence.
Please discuss this issue with your physician. There are other ways to treat erectile dysfunction.
Q. You have suggested that people should check prescriptions carefully to avoid pharmacy errors. How many people read Latin? Why aren't prescriptions written in English? Start a crusade!
A. We have been campaigning against Latin abbreviations in prescriptions for nearly 30 years. There is no excuse for physicians to use this archaic system in the 21st century.
This idea makes some doctors angry, though. One took us to task after we wrote a column calling for prescriptions to be written in legible English: "You do not have a right to tell us to change the standard format in which pharmacists provide service to physicians by saying that we should change the way prescriptions are written and have been forever. Pharmacists are here to serve, not to instruct."
Despite this objection, the leading pharmacology textbook used in medical schools is clear: "The directions to the patient should always be written in English. The use of Latin abbreviations serves no useful purpose."
Q. I have had weakness in my arms and legs, pain in my back, aching arms, loss of memory and fatigue. I have not been able to play golf for more than two years, and I totally lost the quality of life I enjoyed prior to undergoing angioplasty and starting on Lipitor.
If there is to be a class-action suit, I would like to be included. Your article helped me understand the pain and suffering I have endured.
A. Millions of people are able to take cholesterol-lowering drugs like atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor) and simvastatin (Zocor) without complications. But some experience debilitating muscle, nerve or joint pain, weakness, skin rash or memory problems.
The nutrient Coenzyme Q10 may help counteract some of these side effects. You can learn more about how to use it and alternative ways to control cholesterol in our new book, Best Choices From The People's Pharmacy (Rodale Books).
We cannot offer legal advice, though. Several lawsuits have been filed claiming deceptive marketing of statins.
Q. Do nitroglycerin heart tablets lose their potency once the bottle is opened for the first use, or can I go by the expiration date on the bottle? I have gotten conflicting answers from my doctors and my pharmacist. I'm not sure what to believe.
A. Nitroglycerin evaporates easily, which is why these pills should never be left out in the open or in a plastic pillbox. Store them in the original amber glass bottle with the cap screwed down tightly.
If there is cotton in the bottle, take it out and throw it away, as it can absorb the medicine. If you replace the cap firmly as soon as you remove a pill, you should be able to rely on the expiration date on the label.
THE PEOPLE'S HERBAL PHARMACY
Q. I suffer from gout from time to time. Have you ever heard of curry relieving the symptoms? My wife made a soup containing curry, and within one hour after eating it, I could feel the pain going away. I ate the soup the next two nights, and my gout was 95 percent gone. This worked much better than cherries for me.
A. Thanks for the tip. Gout is a painful inflammatory condition in which uric-acid crystals collect in the joints. The yellow spice in curry powder is turmeric. It has been used for centuries in the traditional medical system of India to treat inflammation. Research in animals confirms that turmeric extracts can reduce joint swelling from experimental arthritis (Journal of Natural Products, March 2006).
Q. I am taking a product that contains cascara sagrada to promote healthy digestion and relieve hemorrhoids. How often should I take it?
I took one dose of it at night, and the next afternoon experienced diarrhea. That has me a bit worried about taking it every day.
A. Cascara sagrada is a strong laxative, so we're not surprised it gave you diarrhea. We don't recommend taking stimulant laxatives on a regular basis since they can deplete the body of essential minerals. Daily use also may lead to dependence.
Q. My 8-year-old son has eczema. We have been alarmed by the recent studies about Elidel increasing the risk of cancer.
We also do not want to go back to topical steroids because they might thin his skin too much. Are there any other treatments that we can consider?
A. Besides a good moisturizer to keep the skin from drying out, you might want to consider DermaSmart undergarments and pajamas (
www.dermasmart.com). This special fabric is super-soft and nonirritating.
A firefighter told us that he developed eczema after exposure to mold in an older fire station. When he put on his protective gear the itching nearly drove him crazy. The DermaSmart T-shirt and pants reduced the irritation and itching.
Another interesting product is CamoCare Soothing Cream (
www.CamoCare.com). It contains a camomile-derived oil that is anti-inflammatory.
Q. I take prescription heart and blood-pressure medicine that keeps me awake. My doctor has prescribed Ambien, but my insurance company rations me so I can't take it every night. When I don't take Ambien I don't sleep.
What's the problem with this sleeping pill? What else can you suggest so I can get some sleep?
A. A surprising number of prescription and OTC medicines can cause insomnia. If your doctor could prescribe different drugs, your insomnia might disappear.
If that is not an option, ask your doctor to intervene with the insurance company. Some insurers restrict prescription sleep aids on the grounds that the Food and Drug Administration has not approved these drugs for daily use.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
