FDA approves label change to reflect potential hearing loss from E.D. drugs
WASHINGTON The Food and Drug Administration has approved labeling changes for erectile dysfunction drugs to add a new warning for the potential risk of sudden hearing loss.
The drugs included are Cialis, Viagra, Levitra and Revatio, which is used to treat pulmonary arterial hypertension. Patients taking any of the drugs besides Revatio are being told to discontinue taking the medication and contact their prescriber immediately if they begin experiencing any type of hearing loss.
In most cases discovered, the hearing loss is in one ear and it was either partial or complete loss of usual hearing. About one third of the cases were temporary and as of now the hearing loss continued in the other reported cases.
FDA approves label changes for Accutane and its generics
The Food and Drug Administration has approved label changes to Roche’s acne medication Accutane and its generic isotretinoin, manufactured by Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories.
The label changes were made to improve the management of the iPledge pregnancy risk management program. Pregnant women are not allowed to take the medication due to risk of birth defects.
Roche, who proposed the changes, said they are intended to enhance the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function.
The changes are planned to go into effect on Dec. 2.
FDA approves Ixempra for breast cancer
WASHINGTON The Food and Drug Administration has approved Bristol-Myers Squibb’s Ixempra monotherapy for the treatment of patients with metastatic or locally advanced breast cancer whose tumors are resistant or refractory to anthracyclines, taxanes and capecitabine.
The FDA has also granted approval of Ixempra in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to an anthracycline and a taxane or whose cancer is taxane-resistant and for whom further anthracycline therapy is contraindicated.
BMS anticipates Ixempra will be available soon.