May 6

QuaterWatch: 1,000 + deaths –>Digoxin / Suicide/ Violence –>Chantix

* During the third quarter of 2008 the FDA received 24,872 serious adverse drug event reports identifying 854 different drugs.
 For the third quarter of 2008 reported serious, disabling adverse drug events were 30.5% higher than the same quarter one year ago.

The cases described 2778 patient deaths, 1162 cases of disability and 20,932 cases of other kinds of serious injury.
Reported patient deaths in the third quarter were 41% higher than the same quarter in the previous year.

*More than 1,000 patient deaths have been reported in connection with the recall of the heart drug digoxin, but a year later no testing has been performed to determine how many are directly linked to defective tablets."

*More than 100 cases of serious injuries were reported in connection with a muscle relaxant (Lioresal Intrathecal) that is delivered to the spinal fluid through an implanted pump."

Bear in mind that the adverse drug events reported to the FDA is miniscule–estimated at between 1% and 10% of the actual adverse events related to FDA-approved, marketed prescription drugs. That should, but has not, prompted the FDA to take timely action when a significant number of serious adverse effects are reported about a particular drug.

The ISMP report shows that even as more than 1000 patient deaths have now been reported
in connection with the recall of 800 million Digoxin tablets manufactured by the Actavis Group,
one year after the announcement of the recall, no testing of returned tablets has been performed
to establish how many of these deaths resulted from a manufacturing defect, and how many
might have resulted from other safety problems

The tablets were recalled because of the possibility that the strength of tablets was greater
than labeled and might provide a potentially lethal overdose to patients taking the drug to aid failing hearts.

Furthermore, a new recall of digoxin tablets in March 2009 from another manufacturer—Caraco Pharmaceutical Laboratories—underlines weaknesses in the U.S. system for insuring quality control in the manufacture of generic drugs.

This problem has received little public or official notice in part because the FDA does not require that the size of the product recall be disclosed. And the size can vary from a few thousand tablets to nearly a billion.
As a consequence of FDA’s failure to warn about the scope of the recall, doctors don’t have a clue, and patients who had filled prescriptions prior to the recall are being killed by defective pills.

This drug, prescribed to help people stop smoking, continued to ACCOUNT FOR MORE REPORTS OF
SERIOUS PSYCHIATRIC SIDE EFFECTS than any other prescription drug.

Since Chantix approval, QuarterWatch identified 30 possible cases reporting physical ASSAULT, 148 cases mentioning homicidal thoughts and 331 cases of behavior described as aggression.
The FDA has failed to require prominent warnings about the assaultive behavior triggered by Chantix.

The authors, Thomas J. Moore, Senior Scientist, Drug Safety and Policy, ISMP, Michael R. Cohen, President, ISMP
Curt D. Furberg, MD, PhD, Professor of Public Health Sciences, Wake Forest University School of Medicine,
recommend that the Medication Guide for varenicline (Chantix) should be strengthened to include warnings about risk
of vehicle and other accidents, and of psychiatric side effects involving aggression and violence towards others.

The authors discovered a system-wide error in how case reports were being coded as “initial” or “follow up.”
Numerous reports were coded as “follow up” when  there was no record of an initial report having ever been received.
Some drug manufacturers are using many different names to identify the same drug product in reports submitted in the same quarter. For example, we found one company used 11 different names to describe the drug product leuprolide.

posted by Vera Sharav

QuaterWatch authors’ conclusion:

"It is increasingly clear that the nation is experiencing serious problems in insuring
that generic drugs are manufactured with adequate quality control. In the first quarter of
2008, there were large urgent recalls of most of the nation’s supply of one form of the
drug heparin 2 and of millions of fentanyl patches from several drug manufacturers. 3 In
the second quarter, about 50% of the nation’s unexpired supply of digoxin was recalled
because of potential over strength tablets, and an additional digoxin recall was announced
in March 2009. In the third and fourth quarters of 2008, additional urgent recalls were
announced for morphine sulfate, propafenone, and isosorbide—all drugs where over or
under strength tablets could have significant health consequences. 4 In addition, two
New Jersey plants of the Actavis Group were closed because of manufacturing problems,
and all products manufactured there recalled. In December 2008 KV Pharmaceuticals’
plants were closed to resolve quality control problems.

This problem has received little public or official notice in part because the FDA
does not require that the size of the product recall be disclosed. It can vary from a few
thousand tablets to nearly a billion. For example, neither Caraco Pharmaceutical
Laboratories nor the FDA would reveal how many digoxin tablets were involved in its
March 31, 2009 recall notice.6 The FDA’s current system for inspecting plants, dealing
with violations and managing product recall notices requires systematic independent

We continue to be concerned about the safety profile of varenicline (Chantix)
which continues to account for more psychiatric side effects reported to the FDA than
any other prescription drug. In this report we focus on reports of violence towards others
which are not adequately described in the current Medication Guide for patients. In
addition, no action has been taken to provide a prominent warning about the potential of
varenicline to cause motor vehicle and other types of accidents through its effects on
mood, memory, vision and motor control."

See, full ISMP QuaterWatch report at:

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