FDA Panel Advises Strict Limits on Testosterone Prescriptions

FDA Warning sign

Assuming the FDA adopts the advice of the panel, the drug companies will be forced to severely alter marketing strategies and the number of men prescribed these drugs will be significantly reduced. The recommendations might also impact insurance coverage of testosterone prescriptions.

On June 19, 2014 the FDA announced that labels for these drugs are now required to include warnings pertaining to the risk of blood clots.

Questions remain concerning the long-term risks of testosterone and prior studies have linked the medication to increased rates of heart disease. The same panel  voted 20 – 1 for the FDA  to require further studies be conducted related to cardiovascular risk and testosterone use. On Thursday, September 18th, the panel voted 18 – 3 against the approval of the oral testosterone drug Rextoro; the panel concluded that the risk-benefit ratio fails to support FDA approval.

GM Ignition-Switch Defect Now Linked to at Least 21 Deaths

Ignition assembly of GM vehicleGM has establish a Voluntary Compensation Fund for victims of the defective ignition switch in GM vehicles. The program is intended to cover victims killed or seriously injured when the airbag failed to deploy because a defect in the ignition switch causes the vehicle to stall, disabling air bags.

The program was launched on August 5, 2014. According to a report from Kenneth Feinberg, the administrator of the fund, 21 deaths and 16 claims of serious injures have been determined eligible for compensation from the fund. As of Friday, September 19th, 143 death claims have been received. A recent article from Reuters disclosed that $400 million has been set aside by GM to cover compensation costs for the victims of the recalled ignition switch.

Based on Feinberg’s announcement outlining the details of the compensation fund, the deadline for submitting claims is December 31, 2014. The full text of the announcement is available at www.GMIgnitionCompensation.com

For more information about the ignition defect and the vehicles covered by the recall see the GM Ignition Recall Safety Information  website and the NHTSA Consumer Alert.