FDA asks Ariad Pharmaceuticals to suspend sales, marketing of Iclusig amid side-effect concerns
SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.
The FDA issued a notification concerning the drug Iclusig (ponatinib), saying it had found an increased frequency of life-threatening blood clots and severe narrowing of blood vessels in patients taking the drug since its December 2012 approval. Patients taking the drug should discuss with their providers the risks and benefits of continuing treatment with it.
"We will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks," FDA Division of Drug Information pharmacist Sadhna Khatri said in a podcast on the FDA website.
The agency said Ariad had agreed to the request and recommended that patients taking Iclusig and not responding stop taking it and discuss alternative treatment options; that patients taking the drug and responding discuss it with their providers; and that prescribers not start treating new patients with it unless there are no other treatment options available and all other therapies have failed.
Drug for hypertension in children launched
DENVER — Silvergate Pharmaceuticals has launched a new drug for treating high blood pressure in children, the company said Monday.
The drug maker announced the availability of Epaned (enalapril maleate) powder for oral suspension, for treating hypertension in patients older than 1 month. Enalapril is one of the most commonly prescribed medicines in the United States for high blood pressure. Epaned was approved in August 2013 as a flavored liquid solution to appeal to children and others who have difficulty swallowing enalapril tablets.
"We’re pleased to launch Epaned so quickly after receiving FDA approval," Silvergate president and CEO Frank Segrave said. "Silvergate is happy to take the lead in developing FDA-approved medicines for children, an area of drug development that is often overlooked."
Good Neighbor Pharmacy, KaBOOM! and the Community YMCA design, build dream play space for children
RED BANK, N.J. — In less than eight hours, a play space was built at the Community YMCA’s Family Health and Wellness Center with the help of more than 200 volunteers from the Community YMCA, Good Neighbor Pharmacy and non profit KaBOOM!, the companies announced Monday. The new playground — which was made possible by funds donated by Good Neighbor Pharmacy and matched by its parent company, AmerisourceBergen — will serve hundreds of children in the community for years to come.
“The Community YMCA is truly grateful to KaBOOM! and Good Neighbor Pharmacy for their generosity and commitment to ensuring that all children have a safe place to play,” stated the Community YMCA president and CEO Rhonda Anderson. “We thank them and the many hardworking volunteers and local businesses who supported this project. Together, we are making a lasting impact for children in our community.”
Planning for the playground began at a design day event held on Sept. 3, where local children and community leaders met with organizers from KaBOOM! and Good Neighbor Pharmacy to design their dream playground. The children’s drawings were then used to create the final playground design.
“Good Neighbor Pharmacy is thrilled to have the opportunity to give back to local communities like Red Bank through our partnership with KaBOOM!,” stated AJ Caffentzis, SVP sales and marketing, at AmerisourceBergen. “We are committed to the health and well-being of our customers, employees and communities. Our Good Neighbor Pharmacy members, in particular, remain cornerstones of their respective communities, working to improve patient access and patient health in local neighborhoods across the country. We view our partnership with KaBOOM! as an extension of our commitment to local communities.”
The playground is the first of five that will be built together by KaBOOM! and Good Neighbor Pharmacy, the companies noted.