How many deaths from Vioxx?

So how many people actually died in the US after taking Vioxx? While Merck argues that no one has ever died due to Vioxx, but Dr. David Graham initially estimated that up to 50,000 Americans were dead after taking Vioxx. Earlier this month, he estimated that as many as 60,000 American deaths may be attributed to Vioxx.

In an interesting development, Natural Solutions Foundation, a health freedom advocacy organization, in a press release is estimating that as many as 55,000-188,000 American deaths occured due to Vioxx. They attribute their estimate to FDA.

So how many Americans are dead due to Vioxx? Only time will tell.

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Fentanyl patch recall likely

Looks as if painkillers continue to provide painful news to Americans. All the way from Vioxx, Bextra, and Celebrex to Aleve, Ibuprofen, Arcoxia, Diclofenac, and others, there is plenty of news to worry about if you have pain. Now comes a Public Health Advisory on the Fentanyl Patch.

The FDA is now concerned about the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches.

The FDA is conducting an investigation into the deaths associated with these patches. In other words, it is not a recall of Fentanyl patch yet, but that is what might happen if the FDA learns more about the dangers of the patch and its association with the deaths. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.

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. Fentanyl skin patches are very strong narcotic (opioid) painkillers that may cause death from overdose. The fentanyl skin patch should always be prescribed at the lowest dose needed for pain relief, according to FDA guidelines.

Fentanyl skin patches should not be used to treat short-term pain, pain that is not constant, or for pain after an operation. Fentanyl skin patches should only be used by patients who are already taking other narcotic painkillers (opioid tolerant), and who have chronic pain that is not well controlled with shorter-acting painkillers. (Recommended link: Pain relief drug guide)

Patients who are using the fentanyl skin patch and their caregivers should be told about safe methods for storage and disposal of used, unneeded or defective fentanyl skin patches. Fentanyl skin patches should be stored in a safe place and kept out of the reach of children. Safely dispose of used, unneeded or defective fentanyl skin patches by folding the sticky side of the patch together (until it sticks to itself) and flushing it down the toilet.

Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused. If these signs occur, patients or their caregivers should get medical attention right away.

A patient using the fentanyl skin patch may have a sudden and possible dangerous rise in their body level of fentanyl or have a stronger effect from fentanyl if they: use other medicines that affect brain function; drink alcohol (beer, wine or distilled spirits); have an increase in body temperature or are exposed to heat; or use other medicines that affect how fentanyl is broken down in the body.

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Recall Natrecor, Eric Topol demands

When Dr. Eric Topol speaks, the world listens. He is considered to be an authority on the subject of heart diseases. He is also not shy about saying what is on his mind. Traditionally, it is mostly the scientists who have been interested in what he has to say but after he highlighted the dangers of Vioxx, millions of people worldwide want to know what he thinks.

After his criticism of Vioxx early on did not have much impact on either Merck or FDA, he was proved right later on after more evidence about risks of Vioxx was published. Vioxx was eventually recalled last year.

Now he is on his next mission - to force FDA and Scios (a subsidiary of Johnson & Johnson) to recall Natrecor. He is asking why a drug that causes a lot of side effects on your kidney and costs a fortune ($500 a dose, while cheaper alternatives that cost just ten bucks are available) is still on the market? He shared his thoughts on the matter in an article in the New England Journal of Medicine.

Since Natrecor was approved, a lot of questions have been raised about the safety of the drug, but nothing has changed due to inertia at the FDA. Plus, some doctors refuse to ignore scientific research since administration of Natrecor is so lucrative. Like many other drugs, Natrecor was approved by the FDA based on sketchy safety data and then FDA has chosen to look the other way while the company markets the drug aggressively. (Related article: Natrecor increases risk of death)

Some other statistics will surprise you. Dr. Topol finds that for each American doctor there are five salespeople. He is recommending that Natrecor be recalled despite the fact that a panel at Cleveland Clinic did not act on this matter. In his opinion, "Nesiritide (Natrecor) has not yet met the minimal criteria for safety and efficacy. Until a trial definitively proves that this drug reduces the risk of death or repeated hospitalization for heart failure, there will be questions about the appropriateness of the drug's use or even commercial availability. We need a tune-up of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety." (Related article: Natrecor label revision)

By the way, our friends in Europe do not think that the drug is safe enough to be used by Europeans. In the meantime, Scios has written a letter to doctors to be more careful in prescribing Natrecor.

Recommended article: Natrecor prescription guidelines changed

Viagra, Cialis, Levitra label show blindness risk

The Food and Drug Administration (FDA) has approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

Pfizer, the manufacturer of Viagra, has argued that there is no linkage between Viagra and blindness, and the FDA agrees that at this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.

FDA is advising patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes. Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.

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Prozac-type drugs being investigated by FDA

Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. The issue has been raised off and on but the drug companies have either suppressed the evidence or simply not let it come out. Late last year, there was a big controversy regarding Prozac, but nothing much happened. (Related article: Prozac lawsuits)

Looks like FDA is now acting on thse complaints from consumer groups. FDA has begun a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that:

• Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased.
• Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.

The drugs being reviewed are:
Celexa (citalopram)
Cymbalta (duloxetine)
Effexor (venlafaxine)
Lexapro (escitalopram)
Fluvoxamine
Paxil (paroxetine)
Prozac (fluoxetine)
Remeron (mirtazapine)
Serzone (nefazodone)
Wellbutrin (bupropion)
Zoloft (sertraline)

FDA’s comprehensive review will involve many hundreds of individual clinical trials and many thousands of adult patients. It is expected that this review will require a year or more to complete (likely completion mid-2006) because of the large number of trials and the thousands of adverse events that must be checked for possible evidence of suicidality. The FDA announced that it will make the results of its review available to the public once its analyses are complete, and will update this advisory in the meantime if more definitive information becomes available.

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