The U.S. Food and Drug Administration (FDA) is warning the public that the leukemia drug ponatinib—sold under the brand name Iclusig—might cause serious blood-clot side effects.
What Is Iclusig and What Is It Prescribed For?
ARIAD Pharmaceuticals, Inc., a Massachusetts-based company that specializes in cancer drugs, developed ponatinib to treat chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL). The FDA approved Iclusig in December 2012 under an accelerated process.
Iclusig is a “tyrosine-kinase inhibitor,” meaning it interferes with the ability of enzymes in cancer cells to help the cancer spread. Doctors can prescribe it if patients’ cancers are found to be intolerant to other tyrosine-kinase inhibitors because ARIAD designed Iclusig to combat forms of leukemia that are resistant to other forms of treatment. Iclusig comes in the form of 15 mg and 45 mg oral tablets.
Iclusig is controversial for two reasons: One, initial drug trials showed that it could cause arterial thrombosis (blood clots) and hepatoxicity (liver toxicity), leading to a black box warning on the drug’s label when the drug was approved. Two, according to an article in the New York Times, a year of Iclusig treatment can cost more than $100,000.
Iclusig Might Cause Blood-Clot Side Effects
Since before the drug was approved, medical scientists have known that dangerous side effects could accompany Iclusig use. In clinical trials, 8 percent of patients using Iclusig developed arterial blood clots, and 3 percent of patients developed blood clots in their veins. On October 11, 2013, the FDA issued an Iclusig safety announcement informing the public that Iclusig’s most recent clinical trial showed that blood clots formed in 20 percent of patients.
Because Iclusig was approved under an accelerated process, ARIAD was required to conduct additional drug trials after Iclusig received approval. Based on the results and adverse event reports, the FDA warned that the drug might cause the following side effects:
- Heart attacks that sometimes result in death
- Worsening of coronary artery disease
- Narrowing of large arteries in the brain
- Severe narrowing of blood vessels in the extremities necessitating surgical procedures to restore blood flow
- Congestive heart failure
- Loss of blood flow to extremities leading to tissue death and amputation
- Decreased vision
- Blood clots in ocular blood vessels.
These side effects all appeared in patients regardless of age and previous history of congestive heart failure.
Because of these findings, ARIAD announced in a press release that it paused enrollment in its critical trials, subject to an agreement with the FDA. Many patients’ Iclusig dosage will be reduced from 45 mg. Subsequent clinical trials will exclude patients with a history of arterial thrombosis.
Subsequently, on October 31, 2013, the FDA requested ARIAD Pharmaceuticals cease selling and marketing Iclusig because of the risk of blood clots. ARIAD has agreed to the suspension pending the completion of further research by the FDA. The agency recommends physicians not start patients on Iclusig unless no other treatment option exists and other treatments have failed. Patients who are not responding to the drug should consult with their physicians about discontinuing Iclusig therapy, and patients who are responding to Iclusig should consult with their physicians about whether continuing treatment is worthwhile.
The FDA issued another Iclusig drug safety communication on December 20, 2013, discussing the safety changes it would require ARIAD Pharmaceuticals to make before it could sell the drug again. The safety measures include:
- narrowing the drug’s indication
- providing additional warnings and precautions about the risk of blood clots and severe narrowing of blood vessels due to Iclusig use
- revising recommendations about dosage and administration of Iclusig
- updating the patient Medication Guide
- requiring a risk evaluation and mitigation strategy (REMS) by ARIAD
- ARIAD Pharmaceuticals will conduct postmarket investigations
The agency decided to implement these measures after holding hearings and a review of the available data from Iclusig’s phase 1 and 2 clinical trials revealed that 27 percent of the drug’s users reported suffering from life-threatening arterial and venous thrombosis and occlusions.
RLG’s Iclusig Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Iclusig lawsuit on your behalf if necessary. RLG will also keep you up to date on any Iclusig class action lawsuits, additional FDA Iclusig warnings, and Iclusig FDA recall announcements. If you or a loved one took Iclusig, and you believe it caused an injury, contact RLG today.