Good Medical Care for the Elderly and How to Get It

FDA Warns About Unapproved Nitroglycerin Tablets

Patients who take nitroglycerin tablets may ask whether they are receiving an unapproved brand subject to recent FDA action, as reported in the New York Times on Friday. The FDA sent warning letters to two major manufacturers of unapproved nitroglycerin: Konec, Inc. and Glenmark Generics, Inc. The drugs are not being recalled; the manufacturers have 180 days to stop shipments.

According to the article, some manufacturers previously argued that they didn't need approval because nitroglycerin was available before the FDA was formed. The FDA says the drugs need prior approval and that some unapproved versions have "significant quality and efficacy problems." Only Pfizer has FDA approval to market nitroglycerin tablets.

Antipsychotics inappropriately prescribed for dementia

Even short-term use of typical or atypical antipsychotic medications in the elderly with dementia produces serious events. If you are a regular reader of this Blog, then you know that I frequently write about the dangers of using antipsychotic medications with the elderly. My earlier posts may be accessed here. A new study, released on May 28, 2008, makes clear that even short-term use of these drugs may cause serious complications and even death for the elderly patient. That study was discussed in my May 27 Blog article, and is discussed in a recent article in Journal Watch Psychiatry June 23, 2008

Antipsychotics prescribed to elderly | Adverse event

Today, the Archives of Internal Medicine published a "retrospective cohort study" in which is is reported that the short-term use of antipsychotic therapy in older people with dementia is often followed by adverse events leading to hospitalization or death.

Shortly after my mother died in November 2000, I filed a report with the FDA's Med Watch --a reporting system for adverse medication reactions causing death and other serious complications. I told the FDA that risperidone, an atypical antipsychotic, prescribed for my mother when she was delirious was a likely contributing factor in her death. What did MedWatch do with this report?

New restrictions on anti-anemia drugs

An FDA advisory panel has recommended further strengthening warnings for the use of erythropoiesis-stimulating agents in cancer treatment, according to news reports.

The panel voted to recommend keeping Aranesp (darbepoetin alfa) and Procrit (epoetin alfa) on the market to treat anemia resulting from chemotherapy. But it said they should be given only to patients with incurable cancer and should not be used for those with breast or head and neck cancer. Evidence that the drugs may increase the risks for death and tumor growth led to the new restrictions.

The panel also advised that patients should sign forms indicating that they consent to receive the drugs after being fully informed of the dangers associated with them, according to the New York Times.

The New York Times story may be read here.

Avoiding an inappropriate psychiatric hospitalization

Recently, a caregiver complained that a hospital would not allow her to elect a transfer to a psychiatric unit for her parent suffering from dementia. The hospital’s position was that the health care power of attorney did not allow the patient advocate to make a psychiatric admission. They said that only the patient could make that choice. The patient was described as being “delusional.” What seemed probable was that this patient was delirious, not psychotic. If that were the case, then a psychiatric admission would potentially be very harmful to the patient.

Avoiding an inappropriate psychiatric hospitalization for an elderly person can be life-saving for that patient.

Heparin warnings

The New York Times reports today that Baxter Healthcare, the manufacturer of about half of the heparin used in the U.S., has stopped making it after hundreds of patients reported severe allergic reactions to the drug. Heparin is a blood thinner widely used in surgery and dialysis. Reportedly, at least four people have died. It's important to note that the complications reported were related to large dosages being injected in patients. Most of the cases were reported in late December or January. 40 percent of the cases were reportedly serious.

Federal regulators say that a shutdown in manufacturing will surely result in shortages of the drug.
Alternative drugs do exist. However, doctors were warned today of serious consequences if heparin becomes truly scarce.

You may read the New York Times article, Problems in Drug Lead to Halt by Factory here.

Commonly prescribed drugs cause most adverse drug events in elders

When I began my research to learn what had caused the death of my mother only 65 days after she had been diagnosed with a simple urinary tract infection, one of my first goals was to learn whether an antipsychotic medication that had been prescribed for her could possibly be linked to her death. I learned that this drug was frequently used in nursing homes to control “behavior problems,” that the drug was intended for use with schizophrenics and that use in the elderly was “off-label” – meaning that the FDA had not approved the drug for that use.

I also learned that research linked use of antipsychotics in the elderly with unacceptable risk of harm to the elderly. In fact, the FDA has since issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., “off-label”) use of certain drugs called “atypical antipsychotic drugs.” No research has demonstrated that antipsychotics are effective in “treating” behavioral problems in the elderly. The side effects of antipsychotics make them particularly dangerous to the elderly. These side effects include anorexia, drowsiness, dizziness, and dangerous “extrapyramidal side effects” such as dystonia (Involuntary movements and prolonged muscle contraction resulting in twisting body motions, tremor, and abnormal posture), Parkinsonism (motor stiffness, difficulty initiating movements, shuffling, stiff gait, resting tremors, and reduced facial movements), and others. EPSs can be life-threatening.

Stronger FDA warnings for Procrit, Epogen, & Aranesp

Additional boxed warnings and label updates for the erythropoiesis-stimulating agents Aranesp, Epogen, and Procrit have been approved by the FDA. Ths issue causing the new warnings relate to drugs dosages that raise hemoglobin levels over 12 g/dL.

Research shows these high dosages stimulated tumor growth and decreased survival in patients with certain cancers: advanced breast, head and neck, lymphoid, and non-small cell lung cancer. It is important to note that researchers have not ruled out higher mortality and tumor progression when hemoglobin rates are raised to levels under 12 g/dL.

Chronic renal failure patients taking these drugs in order to keep hemoglobin levels over 12 g/dL are at increased risk for death, stroke, heart attack, and heart failure. For these patients, the FDA in recommending that hemoglobin levels be maintained between 10 and 12 g/dL.

FDA press release (Free)

Earlier Blog articles related to initial FDA warning, dosing change for erythropoietin

Technorati Tags: Amgen, Epogen, Aranesp

Merck announces plans for new Vioxx-like drug

The Boston Globe reported on March 30, 2007 that Merck is scheduled to appear before the FDA to seek approval for a new painkiller “that is just like Vioxx,” the drug Merck was forced with withdraw from the market in 2004 when research proved that it increased the risk of heart attacks substantially. Just so you know, the new drug is called Arcoxia. While some analysts doubt that the FDA will approve the drug, others are skeptical about the FDA. Legislation is pending that seeks to avoid another Vioxx mess by limiting the type of advertising that can be done with new drugs and to limit the number of doctors who can prescribe them when safety concerns arise after the FDA has already approved a drug.

You can read the entire Globe article here.

Technorati tags: Merck, vioxx, fda, drug safety

Black box warnings for Procrit, Epogen and Aranesp

On March 8, 2007, the FDA issued new warnings and mandated Black Box warnings for Amgen's three medications – Aranesp, Epogen, and also Procrit (the latter is sold by Johnson & Johnson's Ortho-Biotech unit). The black box warnings caution doctors prescribing these drugs for of-label uses treating cancer patients on chemotherapy about dosing levels and the need to monitor red blood cell level. Doctors are cautioned to adjust dosages to maintain the lowest hemoglobin level necessary to avoid the need for blood transfusions. They are also told to carefully weigh the risks associated with these drugs against risks posed by transfusion.

This is the fourth time the labels have been revised.