The voluntary recall has been announced by Takeda Pharmaceutical Co. and Affymax Inc.
The two companies have recalled all Omontys lots which are sold in 20mg and 10mg vials. Doctors have been told not to administer the medication to patients.
All lots of Omontys are affected by this recall:
- 10mg Multi-dose vials
Lots - C18685, C18881, C19258
- 20mg Multi-dose vials
Lots - C18686, C18696
The FDA says that it has been informed about the recall and agrees with the voluntary measure taken by the two companies.
Takeda spokesman, Kazumi Kobayashi, said:
"Our company is working with the FDA and Affymax and decided to voluntarily recall Omontys to put patients' safety first. We will swiftly provide information to patients and health care professionals."
Fresenius Medical Care, USA, said it will halt the Omontys pilot program for the moment, after observing infrequent allergic reactions in patients after their first dose of the medication.
Out of approximately 25,000 patients taking Omontys, 0.02 have had fatal reactions after being administered their first dose., said Takeda. In about 1 in every 500 cases, hypersensitivity reactions (anaphylaxis) have been serious enough to require the attention of a doctor - some of the patients had to be admitted to hospital.
According to a Takeda communiqué, "serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys." The company emphasized that there have been no reports of such reactions after subsequent administrations of drug. In other words, the reactions of concern only occur after the first application of the drug, not second, third, etc.
Takeda says that customers will receive instruction on how to return the medication to the manufacturer for a full refund. If you are a customer and have any queries, you are invited to telephone 1-855-466-6689. The helpdesk is staffed from 9am to 5pm Monday to Friday, Eastern Standard Time.
The FDA invites patients and healthcare professionals to report reactions or quality problems related to Omontys usage to the Agency's MedWatch Adverse Event Reporting program either:
- By fax - 1-800-FDA-0178
- Online at www.fda.gov/medwatch/report.htm
- Regular mail. Use a postage-paid, pre-addressed Form FDA 3500. Mail to the pre-addressed details on the form. The form is available at www.fda.gov/MedWatch/getforms.htm
Actos users' legal representative allege that Takeda either downplayed or ignored concerns regarding the medications potential for causing cancer before it was approved by the FDA in 1999 - Takeda is being accused of misleading the FDA about the medication's risks.
Written by Christian Nordqvist