My, my! The US FDA is very busy these days with new drugs and safety review of approved drugs – all linked to heart health. Let us take a look at what the regulators are up to.
Forest Pharmaceuticals agrees to guilty plea for violating FDA laws
The drugmaker Forest Pharmaceuticals, Inc. has agreed to pay more than $300 million as settlement for “criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.” Among the drugs in question are Levothroid (levothyroxine sodium tablets, thyroid hormone replacement), and Celexa (citalopram), a selective serotonin reuptake inhibitor (SSRI) drug for the treatment of adult depression.
FDA advisors say sibutramine’s CV risks warrant harsher restrictions or withdrawal
The weight-loss drug sibutramine (Meridia) is in big trouble. An FDA advisory panel has recommended adding tougher warnings to its labeling. The other alternative is a full withdrawal from the US market. Postmarketing studies have shown that Meridia has an increased cardiovascular risk profile. Meridia is manufactured by Abbott Laboratories.
FDA issues new dosing guide for children using Valcyte
The US FDA also update the pediatric dosing of Valcyte (valganciclovir) oral tablets and solution for children and adolescents receiving a kidney or heart transplant. The new dosing is now in the product label.
FDA approves new drug for gout
The drug Krystexxa (pegloticase) was approved by the US FDA this week for the indication gout, when patients do not respond to conventional therapy. Gout a painful condition that is caused by “an excess of the bodily waste uric acid, which is eventually deposited as needle-like crystals in the joints or in soft tissue. These crystals can cause intermittent swelling, redness, heat, pain and stiffness in the joints. Gout is strongly associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease. “
FDA will be in dabigatran’s corner at next Monday’s advisory panel meeting
Things are looking positive for the new oral anticoagulant dabigatran etexilate (Boehringer Ingelheim) which is due to be reviewed at next week’s advisory panel meeting. The US FDA thinks the drug should be approved for the prevention of stroke in patients with atrial fibrillation. However, not all members of the panel may agree to this due to controversies about the results of Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial.
FDA approves devices for heart failure patients
It is not only drugs but also medical devices that the US FDA are busy with. It recently approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D). CRT-D is used in the treatment of heart failure. The new indication is for the management of “left bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle.” The CRT-D works as a two-in-one device. It functions as an implantable cardioverter defibrillator (ICD) and as a cardiac resynchronization device that coordinates the beating of the left and right ventricles of the heart.