Innoheptin zaparin sodium side effects
Strength(s): 20,000 IU of anti-Factor Xa per mL, Dosage Form
Subcutaneous injection, Company DuPoint Pharma
December 2008
Celgene issued a warning letter that a study of its drug to
treat dangerous blood clots suggests it may increase the risk of death in
elderly patients. The study was stopped in February 2008 after 350 of the
patients had been followed for three months. By then, 13 percent in the
group getting Innohep had died of various causes. The FDA said it had
received 383 reports of side effects and complications worldwide, including
96 deaths, as of Oct. 15, 2008. [1]

More about Innohep
Pharmion obtained U.S. rights to Innohep(R) from LEO Pharma of Denmark in
July 2002. The U.S. rights were originally licensed to DuPont Pharmaceuticals
by LEO Pharma in 1998. The product received U.S. Food and Drug
Administration (FDA) approval in July 2000 and was initially launched in the U.
S. in October 2000. Following acquisition of DuPont Pharmaceuticals by
Bristol-Myers Squibb in January 2002, Innohep(R) rights were returned to
LEO Pharma. [3] Now, Celgene Corp is the USA marketer. [4]

SOURCE [1] Celgene warns that anticlot drug linked to deaths LINDA A. JOHNSON, AP
Business Writer Linda A. Johnson, Ap Business Writer   – Wed Dec 31, 6:13 pm ET [2]
FDA website December 2008 [3] Pharmion Launches First U.S. Product; New Sales
Force Will Market Innohep -- tinzaparin Thursday, October
3 2002 [4] Tinzaparin sodium - Innohep; low-molecular weight porcine heparin,
enzymatically derivedHeparin, enzymatic deriv. 2008
What is Innohep used for?

Innohep, tinzaparin sodium, is a low molecular weight fragments of heparin derived
from porcine (pig) heparin by enzymatic degradation using heparinase enzymes.  Its
molecular weight is 5500-7500 Dalton. [4]

Innohep is used together with another drug, warfarin, to treat blood clots that have
occurred deep in the veins of hospitalized patients who may or may not have also
experienced the occurrence of blood clots in their lungs (pulmonary embolism).

Who should not be treated with Innohep?

Innohep should not be given to those who:

* are currently experiencing major bleeding
* have a history of heparin causing the blood to have low platelets (thrombocytopenia)
* are allergic to:
o heparin
o sulfites
o benzyl alcohol
o pork products

Tell your health care provider if you have any of these conditions.

Special Warning(s) with Innohep:

Using Innohep or other low molecular weight heparins (LMWHs) to reduce the risk of
problems from blood clots when epidural/spinal anesthesia or spinal puncture is in
use puts patients at risk of developing spinal or epidural injury (hematoma), which
can result in long-term or permanent paralysis.

Innohep, like other drugs that prevent the blood from clotting, is given with extreme
caution in conditions that increase risk of bleeding, such as:

* Inflammation of the heart and/or the tissue surrounding the heart
* severe uncontrolled high blood pressure
* bleeding disorders, including liver failure and certain protein deposits (amyloidosis)
* active ulcerative colitis and other disorders in the stomach and intestines
* bleeding into the brain (hemorrhagic stroke)
* recent brain, spinal or eye surgery
* when taking other medications that prevents the blood from clotting.

Innohep contains a sulfite that may cause a severe allergic reaction including
life-threatening asthma if you are sensitive to sulfites.

General Precautions with Innohep:

Because certain other medications can increase the risk of bleeding with Innohep,
review all medications that you are taking with your health care provider, including
those that you take without a prescription. Tell your doctor or health care provider if
you are taking:

* blood thinners
* salicylates, such as aspirin
* sulfinpyrazone
* dextran
* non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin®), naproxen
sodium (Naprosyn® or Alleve®).

What should I tell my doctor or health care provider?

Tell your doctor or health care provider if you have a history of:

* a tendency to bleed easily
* uncontrolled high blood pressure
* recent stomach ulcer
* eye problems due to diabetes
* recent bleeding
* kidney problems
* hemorrhagic stroke

Because vials of Innohep contain the preservative benzyl alcohol, tell your doctor or
health care provider if you are trying to become pregnant, are already pregnant, or are
breast-feeding. Benzyl alcohol can and may cross the placenta in pregnant women
and cause death in premature babies.

What are some possible side effects of Innohep? (This is NOT a complete list of
side effects reported with Innohep. Your health care provider can discuss with you a
more complete list of side effects.)  

The most common side effect with Innohep is bleeding. [2]