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Do Benefits of Newly Approved Injectable Drug for Alcoholism (VIVITROL) Outweigh Its Considerable Risks?

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By Steven DiJoseph

On April 14, the FDA approved a once-a-month injectable drug known as VIVITROL (naltrexone) for the treatment of alcoholism. While a 24-week clinical trial seemed to indicate the drug could be beneficial, a review of the information on the FDA Web site raises questions as to the risks and dangers associated with the medication. http://www.fda.gov/cder/foi/label/2006/021897lbl.pdf

In determining whether a drug should be approved, an analysis must find that its benefits outweigh its risks. Thus, a beneficial drug that cures a minor medical problem will be unsuitable for marketing if it kills people, while a viable treatment for a deadly disease will often be approved even if it has potentially fatal side-effects.

A problem arises, however, when the risk/benefit analysis goes awry and medications are approved to treat conditions that are far less serious than the drug’s potential side-effects and adverse reactions. The current FDA approval and review process is quite troublesome in that there has been a dramatic increase in the harm or risk that will be tolerated when weighing the potential benefits of a prescription drug.

Traditionally, even drugs which promised significant benefits would be subjected to greater testing over longer periods of time when significant side-effects or adverse reactions were possible. If the drug was developed to treat a relatively minor condition, the possibility of dangerous side effects usually spelled the end of the drug in terms of FDA approval for marketing.

Today, however, drugs are routinely given FDA approval without sufficient long-term testing using large study groups and without adequate warnings despite evidence of significant side-effects and adverse reactions. Drugs are also permitted to remain on the market far longer than they should be once significant problems are suspected or even confirmed.

This has repeatedly resulted either in the need for upgraded warnings one or more times after a drug is already on the market or in dangerous drugs being pulled from the market only after causing numerous serious injuries or deaths.

Probably the most alarming situation today, however, is when a drug designed to treat a relatively minor condition is approved by the FDA and permitted to remain on the market despite clear evidence of significant side effects or adverse reactions.

In such cases, the risk versus benefit equation has all but vanished from the pharmaceutical companies’ consideration and the FDA’s standards. Accutane is an example of such a drug.

For years, that drug has been under siege from numerous medical experts, consumer watchdog groups, and even many officials within the FDA itself because of the numerous Accutane side effects.

For all of the positive results it might have achieved, Accutane is still nothing more than an acne drug.

Accutane has been linked to serious potential side-effects including: birth defects; psychological problems including possible suicide; neurological problems; stomach, bone and muscle problems; hearing and vision problems; ulcerative colitis; Crohn’s disease; inflammatory bowel disorder; rectal bleeding; central nervous system injuries; bone and muscle loss; cardiovascular injuries; liver and kidney damage; pancreatitis; immune system disorder; lupus; thyroid disorders; and various allergic reactions.

By January 2001, the FDA had received reports concerning 66 suicides and 1,373 cases of psychiatric problems.

Birth defects are perhaps the most severe side effects to be linked to Accutane.  The list of possible birth defects include: hydrocephaly (enlargement of the fluid-filled spaces of the brain); microcephaly (small head); heart defects; facial deformities; and mental retardation.

Since its approval, there have been 2,000 incidences of pregnancies among users, many of which ended in abortion.  The FDA, however, has calculated that more than 160 babies were born with defects directly attributable to Accutane usage.

Reports of suicides and birth defects relating to Accutane continue to surface and a study published in 2005 in the American Journal of Psychiatry suggested that Accutane can actually change brain functioning.

Accutane is by no means the only drug that has been approved and marketed despite being more dangerous than the condition it was designed to treat. The approval this week of VIVITROL has again brought that issue to the forefront.

While alcohol dependence can be a serious problem, a reading of the published data with respect to VIVITROL reveals a number of factors that should raise questions as to the actual value of the drug as a treatment for alcoholism. In no particular order, those revelations are as follow.

VIVITROL is a powerful opioid antagonist that will act to blockade the effects of opiates and opioid-containing medications. This would include all opioid analgesics, and opioid –containing medications such as cough, cold, and antidiarrheal drugs. As a result, a number of serious problems can occur.

One is that patients taking VIVITROL will attempt (on their own) to overcome the blockade by administering inappropriately high doses of exogenous opioids. This is dangerous and could lead to a potentially fatal overdose, respiratory arrest, or circulatory collapse.

Another is that the drug will be used for its opioid-blockading effect as a treatment for opiate dependence. VIVITROL is not approved for that purpose and can cause fatal consequences if used inappropriately.

Once VIVITROL has been used as a treatment for alcohol dependence, it may make the patient responsive to lower doses of opioids than previously taken. This increased sensitivity to opioids could lead to life-threatening opioid intoxication, respiratory compromise, or circulatory collapse if the patient were to take opioid-containing medications in the dosages that had previously been safe.

VIVITROL is associated with liver damage and hepatitis. Its hepatotoxicity has the capacity to cause “hepatocellular injury” when taken in high doses. In short, the drug can cause liver injury or liver failure in patients with liver disease.

Because of its opioid-blocking properties, patients should always carry documentation that would alert medical professionals of the fact that VIVITROL is being taken. This could avoid potentially life threatening situations where a patient needs pain medication in an emergency or while unconscious and an opioid analgesic is being considered.

If pain management becomes necessary and an opioid analgesic is required, the amount needed to be effective may be considerably higher than normal in order to overcome the opioid-blocking effect of the VIVITROL. Thus, the drug chosen to reverse the VIVITROL blockade must be monitored by “appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation.”

The clinical trial found VIVITROL users twice as likely as those taking a placebo to suffer depression or mood variations.

There was also an increased rate of suicidality among the VIVITROL subjects, with two completed suicides among the group. As a result: “Families and caregivers of patients being treated with VIVITROL should be alerted to the need to monitor patients for the emergence of symptoms of depression and suicidality and to report such symptoms to the patient’s health care provider.”

VIVITROL is associated with an increased risk of eosinophilic (allergic) pneumonia.

Since the drug may cause an unintended precipitation of opioid withdrawal (“acute abstinence syndrome”) the patient must be “opioid free” for a minimum of 7 to 10 days prior to starting VIVITROL treatment.

Clinical drug interaction studies with VIVITROL have not been performed; neither have appropriate carcinogenesis, mutagenesis, teratogenesis, or fertility studies. There are, however, disturbing findings that relate to these areas.

Insofar as carcinogenesis studies, there was an increase in the number of testicular mesotheliomas (cancers) in male rats and tumors of vascular origin in male and female rats. The “clinical significance of these findings is not known.”

With respect to fertility in rats, there was a significant increase in pseudopregnancy and a decrease in pregnancy rates. The relationship of these findings to humans is not known.

Possible teratogenic effects included increased fetal deaths in rats and rabbits. Since no studies have been done in pregnant women using VIVITROL or naltrexone, women who are pregnant or intend to become pregnant should be warned about the possibility of fetal complications and treatment should only be considered if the benefit to the patient outweighed the risk to the fetus.

Tests have shown that, as to nursing mothers, there is a transfer of naltrexone and 6b-naltrexol into human milk. Coupled with the tumorigenicity in animal studies and potential serious adverse reactions in nursing infants, discontinuance of VIVITROL should be considered in any case involving a nursing mother. No pediatric studies have been done with VIVITROL.

There is insufficient data with respect to geriatric patients.

VIVITROL can aggravate pre-existing kidney problems and impact negatively on those with hemophilia or bleeding problems.

Since VIVITROL is injected intramuscularly and is not released by an implanted pump, once administered it cannot be removed from the body.

VIVITROL may cause dizziness and, thus, may make it inadvisable to drive, work with machines, or perform other dangerous activities while taking the drug.

Other side effects include; a reaction (which may be serious) at the injection site, nausea, headache, fatigue, vomiting, decreased appetite, painful joints, and muscle cramps.

Based on this information that comes straight out of the manufacturer’s (Alkermes, Inc. of Cambridge Massachusetts) filing with the FDA, it would seem that VIVITROL has the potential to turn out to be one of those drugs that is far more dangerous than the condition it was designed to treat.  As one attorney familiar with pharmaceutical litigation we spoke with put it: “This could be a drug whose future may be anything but rosy.”

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