TWO Drug Alerts: Seroquel and Digoxin
#1 Seroquel
Last year we had articles about a number of veterans treated by the
VA in West Virginia who died in their sleep.
They were taking a drug cocktail which included Seroquel.
The families of those dead veterans are still looking for answers.
And now, two of the families testified before an FDA panel looking into
allowing expanded use of Seroquel.
More info on Seroquel is here...
Latest story below:
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http://www.philly.com/inquirer/business/20
090409_A_minor_victory_in_Seroquel_battle.html
A minor victory in Seroquel battle
By Miriam Hill
Inquirer Staff Writer
WASHINGTON - A government panel opened the door a crack yesterday toward
allowing AstraZeneca P.L.C. to sell its Seroquel XR more widely, after
an emotional meeting that included stories from two families who say
their loved ones died after taking the powerful antipsychotic.
The Food and Drug Administration advisory committee recommended the
agency approve Seroquel XR for use as an additional therapy in patients
suffering from depression who do not respond adequately to their current
medications.
AstraZeneca, whose U.S. headquarters is in Wilmington, had asked the
panel to approve Seroquel much more broadly, to treat depression and
anxiety as a single therapy.
Recommending the broader use would have dramatically expanded the market
for Seroquel. The drug is currently approved to treat schizophrenia
and bipolar disorder, relatively rare diseases, and generates $4.47
billion in yearly sales.
Depression and anxiety, by contrast, affect 10 percent to 20 percent
of the population. Wyeth's Effexor XR, one of the world's top-selling
antidepressants, generates about $4 billion in sales annually.
"It's certainly going to help their bottom line, but it's not
the great victory they had hoped for," said Daniel Carlat, a Tufts
University psychiatrist who was not on the advisory panel. He said companies
could use such narrow approvals to market a drug more widely.
Bristol-Myers Squibb, for example, has heavily advertised its schizophrenia
drug Abilify in TV ads since winning approval for its use as an add-on
treatment for depression.
The FDA could still decide to approve Seroquel for even broader uses,
but the agency usually follows the recommendations of its advisory panels.
In a statement, Howard Hutchinson, chief medical officer of AstraZeneca,
said, "We are pleased that the committee found Seroquel XR to be
effective and acceptably safe for use as adjunctive therapy for treatment
of [depression]. . . . We look forward to having further discussions
with the FDA."
Panel members, including scientists from outside the FDA and consumer
advocates, said Seroquel's risks in depression and anxiety outweighed
its benefits. The drug leads to weight gain, and some research suggests
it can trigger diabetes and heart problems.
Schizophrenia and bipolar disorder are more serious psychiatric illnesses
than depression and anxiety, which seemed to change the risk-benefit
calculations for several panelists.
"The risks are fairly well-documented, and I don't think they
are acceptable for this use," said Richard Malone, a panel member
and Drexel University scientist.
Another member, James Neaton, a biostatistics professor at the University
of Minnesota, agreed.
"The bar should be higher," Neaton said. "Twenty-five
to 30 percent of these patients would be treated chronically, and the
longest study was 48 weeks. I accept the fact that the drug is better
than placebo, but the effect is modest, and the cardiovascular risk
is uncertain."
AstraZeneca scientists presented reams of data asserting that Seroquel
was safe and effective for treating depression and anxiety, but several
panelists said they would like to see studies that tracked patients
for several years, because some cardiovascular diseases take that long
to develop.
Allen Jones, a former fraud investigator with the Pennsylvania Inspector
General's Office whose work led to the conviction of a state psychiatrist
for taking bribes from drug companies, asked the FDA to force AstraZeneca
to release every shred of data on Seroquel. He cited documents uncovered
by lawyers suing AstraZeneca on behalf of clients who say they were
injured by Seroquel.
Those documents, released in a court case earlier this year, include
company e-mails in which AstraZeneca employees discussed "buried"
studies and congratulated one another for doing "nice smoke-and-mirrors"
jobs on Seroquel data.
Janette Layne believes Seroquel may have contributed to the death of
her husband, Eric, who was prescribed the drug, along with several others,
to treat the post-traumatic stress disorder he developed after serving
in Iraq.
Eric Layne died at home in West Virginia in January 2008 while his
wife was pregnant with their second child, Jubilee, who accompanied
her mother to yesterday's hearing.
"I am the widow of Sgt. Eric Layne. I found my husband dead when
our son, Shamus, was 17 months old," Janette Layne told the committee
between her tears.
"In summer of 2007, he began taking Klonopin and Seroquel. He
ate excessively and would fall asleep with food in his mouth. He had
tremors and was extremely lethargic. His speech was slurred to the point
I couldn't tell what he was saying. Eric did not have any of these problems
before he took these medications."
She showed a short video of her husband slumped over a table in their
home and barely able to respond to her questions on Christmas, shortly
before he died at age 29.
Stan and Shirley White, also of West Virginia, testified that their
23-year-old son, Andrew, died suddenly after taking the same drugs Layne
did. Some researchers suspect that Seroquel can trigger sudden cardiac
death, and the Whites have asked Congress to look into the unexpected
deaths of about 40 young members of the armed services.
The Veterans Administration determined that White and Layne died "from
combined drug intoxication involving prescribed and nonprescribed medications,"
and said it could not "draw conclusions about the relationship
between medication regimens and these deaths."
"He was told, and I as his mother was told, 'These medications
will not harm you,' " Shirley White told the panel. "I trusted
the doctors to do what was best for my son, and he died in his sleep."
2. Drug Alert Digoxin
A veteran sent me the above photo of a VA prescription vial. The vet
told me he had found out, on his own, that the drug had been recalled,
but he hadn't heard word one from his VA pharmacy.
The drug listed, Digoxin 0.25mg with NDC# 57664-0441-18, has been recalled
by the manufacturer. (see below)
But, to our knowledge, it has not yet been recalled by the VA. It is
not listed on the VA's Medication Safety News page, here...
http://www.pbm.va.gov/VACenterFo
rMedicationSafety-Index.aspx
To double-check on this, I called my VA pharmacy (West Coast). They
knew nothing about it. When I gave them the NDC#, they checked and said
no vets were given that lot number.
I wondered about that.
So, I called the VA pharmacy where the prescription was filled (East
Coast). The VA pharmacist told me the same thing... they knew nothing
about a recall... and they did not fill any Digoxin prescriptions with
that NDC#. How can that be? I'm not sure.
I talked with Veterans' Advocate Jim Strickland who told me that this
is a Class 1 recall, defined this way: Class I recalls go all the way
down to the consumer level and are for dangerous or defective products
that predictably could cause serious health problems or death.
And, this is from a former FDA investigator:
VA departments like VA hospitals and VA District Offices tend to operate
as independent fiefdoms. When you contact the VA people you know, they
may know nothing of the recall and you will have to explain it to them.
You may probably find the recall notice was sent to the department
that purchases the drugs and they never sent it to any pharmacy. The
main VA supply depot may not have forwarded this to the pharmacy's or
notified VA Administrators so the medical staff was alerted. Or the
VA is unaware that this alert is down to the patient-consumer lever
and can injure heart patients.
The doctors may only become aware of the problem when they read it
in medical journals two months after the fact.
Well, we don't want you to find out two months after the fact.
If you are a veteran taking Digoxin with the NDC codes (lot numbers)
listed below, here is what you should do.
1. CONTINUE TAKING THIS MEDICATION. Discontinuing Digoxin could cause
very serious problems.
2. Contact your VA physician immediately and seek guidance regarding
your supply of Digoxin.
And, another complication. There is a Digoxin shortage right now because
of a number of recalls. In fact, one manufacturer has stopped production.
Recall information is below:
The FDA recall page for this drug is here...
http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html
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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals
from the firms involved as a service to consumers, the media, and other
interested parties. FDA does not endorse either the product or the company.
Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary
Recall of All Lots of Digoxin Tablets Due to Size Variability
Contact:
Daniel Movens: (313) 871-8400
Thomas Versosky: (313) 556-4150
FOR IMMEDIATE RELEASE -- DETROIT, March 31, 2009 -- Caraco Pharmaceutical
Laboratories, Ltd. (NYSE AMEX: CPD), a generic pharmaceutical company,
announced today that all tablets of Caraco brand Digoxin, USP, 0.125
mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009,
which are not expired and are within the expiration date of September,
2011, are being voluntarily recalled to the consumer level. The tablets
are being recalled because they may differ in size and therefore could
have more or less of the active ingredient, digoxin. The recalled tablets
were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall
is being conducted with the knowledge of the Food and Drug Administration.
Digoxin is a drug product used to treat heart failure and abnormal
heart rhythms. It has a narrow therapeutic index and the existence of
higher than labeled dose may pose a risk of digoxin toxicity in patients
with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness,
low blood pressure, cardiac instability, and bradycardia. Death can
also result from excessive digoxin intake. A lower than labeled dose
may pose a risk of lack of efficacy potentially resulting in cardiac
instability. Consequently, as a precautionary measure, Caraco is recalling
these tablets to the consumer level to minimize any potential risk to
patients.
Consumers with the products with the following NDC codes that are within
expiration should return these products to their pharmacy or place of
purchase.
Product Identification
Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted
with “437”
Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted
with “441”
NDC Numbers:
Digoxin Tablets, USP, 0.125 mg
57664-437-88 (100-count)
57664-437-18 (1000-count)
Digoxin Tablets, USP, 0.25 mg
57664-441-88 (100-count)
57664-441-18 (1000-count)
Patients using Caraco's Digoxin tablets, USP, 0.125 mg or 0.25 mg,
who have medical questions should contact their healthcare provider
for additional instructions or guidance.
Retailers who have this product should return the product to their
place of purchase. Retailers can call Caraco customer service at (800)
818-4555, Monday through Friday, 8:00 a.m. – 5:00 p.m. EST, for
instructions on how to return the affected product or for any other
inquiries related to this action.
Any adverse reactions experienced with the use of all affected product,
and/or quality problems should also be reported to the FDA's MedWatch
Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail
at Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on
the MedWatch website at www.fda.gov/medwatch.
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