HEALTH ALERT
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Too Many Doctors in the House
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Doctors Warned of Infection, Worsening Heart Failure, and Death in Patients Taking Remicade— Reviewed by Michael W. Smith, MD
Oct. 24, 2001 -- Earlier this month, drug maker Centocor sent letters to doctors and other healthcare workers to warn them of the following problems in some patients taking Remicade:
First, when the drug is used to treat rheumatoid arthritis and Crohn's disease, there have been serious cases of infection, including tuberculosis (TB), and fungal infections.
In some cases, the complications were fatal. After 84 instances of tuberculosis happened worldwide between Aug. 24, 1998 and June 30, 2001, and 14 people were reported to have died, a warning was added to the drug information to tell doctors to be watching for possible infections. Doctors are urged to give patients taking Remicade a skin TB test. And, in places where the fungal infection histoplasmosis is common, doctors are urged to weigh the possible benefits of taking this drug against the risk of serious infection.
See a copy of the warning letter to doctors outlining the infection warnings on the FDA web site.
Also in October, Centocor sent a warning letter to doctors to tell them about what researchers have found when people with moderate or severe congestive heart failure (CHF) took Remicade. In a study of 150 patients, more people with CHF died or needed to go to the hospital for worsening symptoms if they took the drug, compared to patients who did not get it. The risk seemed especially pronounced in people who received the higher dose of the drug: 10 mg/kg. Seven of the 101 patients given Remicade died, compared to no fatalities among those who received a placebo.
In the warning letter sent to doctors, Centocor warned:
- Patients with CHF should not start Remicade therapy.
- Those with CHF who are taking the drug to treat Crohn's disease or rheumatoid arthritis should be reevaluated.
- Doctors should consider stopping Remicade treatment in patients with CHF, but if they decide to continue, patients need to have their heart function closely monitored.
- In patients with worsening CHF, Remicade treatment should be stopped.
See a copy of the warning letter to doctors outlining the instructions about Remicade and CHF patients.
About Remicade
Brand name: Remicade
Generic name: infliximab
How it works: This drug is a genetically engineered substance, grown from elements of the human immune system. It is designed to bind to some of the products that are produced when the body is injured. It is hoped that when Remicade binds, it prevents some of the damage that makes rheumatoid arthritis, Crohn's disease, and other inflammatory illnesses so severe. Since the body makes similar products as heart failure develops, scientists have been trying to determine if the drug can help CHF patients as well.
Drug Alert: FDA Warns Pepcid Linked to Lethargy in Kidney Patients — Reviewed by Dr. Dominique S. Walton
On March 28, 2001, the FDA issued a warning to doctors and their patients about the prescription form of the heartburn drug Pepcid. The federal health regulators received reports that in patients with moderately compromised kidney function, the drug was associated with problems with the central nervous system, causing lethargy. Because elderly people have a higher risk of kidney problems than younger ones, the FDA says doctors should be especially careful in prescribing the drug to their older patients. The warning applies only to the prescription version of Pepcid. The FDA is still determining if such a warning should be given to the over-the-counter formulation as well. Here is more information about the new FDA alert:
It is available in several formulations: as liquids, tablets, or by injection. Over-the-counter tablets have a smaller dose of the medicine and, at the time of the warning, were not affected by it.
The current drug label tells doctors to be careful prescribing the drug to patients who have severe kidney dysfunction. But the new warning is based on reports that even patients with moderate kidney problems need special attention in determining the appropriate dose for them. Doctors know that it takes the body a long time to process the medicine and remove it from the body even in patients with normal kidney function. But in patients with decreased kidney function, the drug remains in the body for longer amounts of time. This higher level of medication could lead to lethargy.
The current label tells doctors that for kidney patients whose organs cleared less than 10 mL of the waste product creatinine, they need to find a dose that would not produce the side effects. Patients may need to go a longer time between doses or take smaller ones. The FDA is now warning doctors that patients with moderate kidney disease may need to follow the same recommendations. These patients have kidneys that clear less than 50 mL of creatinine per minute. The label will be changed to reflect these new recommendations.
Drug Alert: FDA Says Nail-Fungus Drugs Need Stronger Warnings of Liver, Heart Damage
On May 9, 2001, the FDA warned that two prescription drugs used to treat fungal infections of the skin and nails could potentially cause organ damage. Government regulators are requiring drugmakers producing the following two antifungal drugs to update their warning labels regarding these risks.
Doctors are being told that they should get lab tests to confirm a patient has a fungal infection before prescribing either of these two drugs. The manufacturers of the drugs are sending physicians a letter explaining the new labels.
Here are more details about these two antifungal drugs:
Brand name: Sporanox
Generic name: itraconazole
Risk: The FDA says the maker of this drug, Janssen Pharmaceutica Inc of Titusville, N.J., must include a stronger warning of the possibility of suffering liver damage while using this medication -- including liver failure and death. The FDA has reviewed 24 cases, including 11 deaths, in which Sporanox could have contributed to liver failure.
Also, new labels will state that patients with heart disease should not use this drug. The FDA announced that there was a "small but real risk of developing congestive heart failure associated with the use of Sporanox." The government based its announcement on studies that showed when some people used the drug, their heart lost some of its squeezing power and could not pump blood as well as usual. The effect was reversed when these people stopped using Sporanox.
In all, the FDA believes that the drug was a contributor to the development of congestive heart failure in 58 of 94 reported cases since 1992. There also were 13 deaths, but whether Sporanox was responsible, the FDA says, "is very unclear." It is difficult to attribute the cause of death because nearly all of these patients had other serious health problems at the same time.
Brand name: Lamisil Tablets
Generic name: terbinafine hydrochloride
Note: The new warning applies only to the tablets. The cream and solution versions of Lamisil are not affected by this FDA warning.
Risk: The FDA is requiring the maker of this drug, Novartis Pharmaceuticals of East Hanover, N.J., to strengthen its warning label about the chance of developing liver damage, which can include liver failure or death. The agency said it had reviewed 16 cases in which Lamisil could have contributed to the development of liver failure, including 11 deaths.
What to do: Talk to your doctor at once if you are taking either of these antifungal drugs, especially if you have heart disease or liver problems.
© 2001 WebMD Corporation. All rights reserved
FDA Strengthens Warning About Painkiller OxyContin Reviewed by Dr. Dominique S. Walton
The drugmaker has told 800,000 doctors about the new warnings as well.
OxyContin is intended to treat people experiencing severe pain, such as cancer patients and others with serious illnesses. It's not to be used by people with temporary pain from dental or surgical procedures. The worry is that leftover pills can find their way into the hands of substance abusers, who have learned to crush the pill, snort it, or inject it for a quick, but potentially fatal, high. More than 100 deaths have been linked to it.
Here is more information about this issue:
Brand name of the drug: OxyContin
Generic name: oxycodone hcl controlled release
Manufacturer: Purdue Pharma
The pill is designed to release the painkilling drug over a 12-hour period. But chewing or crushing the pill destroys the time-release delivery and causes more of the drug to be used all at once.
Pockets of rural America have been hit especially hard by OxyContin abuse. There have been many reports of problems in Maine, Virginia, West Virginia, Ohio, Kentucky, and Maryland.
Drug Alert: New Warning to Women Taking Blood Thinners and Vaginal Antifungals Containing Miconazole— Reviewed by Dr. Aman Shah
On Feb. 28, 2001, the FDA announced it is telling all companies that make over-the-counter vaginal creams or suppositories containing the antifungal drug miconazole to add a warning label to their product packaging. Doctors have found that women who use these products while taking the blood-thinning drug warfarin can show increased reactions to the blood thinner as well as suffer bleeding or bruising.
"Ask a doctor or pharmacist before use if you aretaking the prescription blood-thinning medicine warfarin, because bleeding or bruising may occur."
The FDA also asked the manufacturers to notify doctors about the possibility of this drug interaction and the need to monitor patients more closely when they take these drugs together.
Background: Blood thinners work by slowing the clotting action of the blood. The FDA has learned from two adverse event reports that when some women use these miconazole products at the same time to treat a vaginal yeast infection, they can experience increased reactions to their blood-thinning therapy. Some women showed an increase in the amount of time it took for their blood to clot, beyond what the blood thinner would cause by itself. One woman increased her clotting time and also developed bruises, bleeding gums, and a nosebleed.
Read the FDA advisory, which includes references to two medical articles about this drug interaction that you can bring to your doctor.
Read an FDA talk paper on the new information to be provided about this drug interaction.
The FDA says that the packaging information for warfarin already contains warnings about its interactions with miconazole taken systemically -- orally or by injection.
What to Do: Some patients might need to use a miconazole product while on blood-clotting therapy. In this case, both the prescribing physician and the patient should know that appropriate monitoring is necessary so the increased effects of the blood thinners will not happen.
