FDA warns against use of Fentora by non-cancer patients
WASHINGTON The Food and Drug Administration on Friday said that allowing Cephalon to sell its cancer pain drug Fentora to patients without cancer could lead to potentially fatal abuse, according to published reports.
The company is looking for approval to market the drug for sudden pain bouts in non-cancer patients. The FDA staff concluded that the risks of an “unintentional potentially fatal overdose,” as well as of misuse and abuse, are “extremely high” and raise “serious safety concerns,” an FDA document said.
The drug has been prescribed “off label” to treat ailments such as migraine headaches, sports injuries and back pain. The agency has said that it is dangerous to use Fentora to treat short-term pain such as migraines, and only patients who take opioids regularly and have developed a tolerance to narcotic pain medicines should use Fentora.
An FDA advisory panel will meet Tuesday to discuss the expanded use. Cephalon expects the FDA to make a final decision by Sept. 13.
Hormone deemed effective in male birth-control pill
TORRANCE, Calif. According to published reports, one of the two government-funded research centers in the U.S. for male contraceptives has discovered hormone pills that block sperm production in men and has found them to be safe and reversible.
The hormone combination that proved most successful halts testosterone production in the testicles, but fakes the body into believing that testosterone levels are the same, according to the study. The progestin, typically a female hormone, speeds the process and improves the effectiveness of the drug, research shows. The hormones can be taken in a pill or injection form.
As with female birth control, the male contraceptives don’t prevent sexually transmitted disease. But they have proven as effective as female pills in preventing pregnancy, according to the study.
The next goal is to find pharmaceutical companies that want to conduct final development of the drug, but so far companies have been unwillingly to take part because of the regulatory requirement involved in manufacturing a contraceptive.
Federal appeals court lets Washington state Plan B ruling stand
LOS ANGELES A federal appeals court on Thursday left in place a lower court’s ruling that allowed Washington state pharmacists to refuse to sell Duramed’s emergency contraceptive pill Plan B on religious grounds, according to Reuters.
A federal judge in Seattle suspended state rules that required pharmacies to dispense the drug and other emergency contraceptives that prevent fertilized eggs from implanting, which some people believe is the same as abortion.
U.S. District Judge Ronald Leighton found that the state rules force pharmacists into an unconstitutional choice between their religious beliefs and their work.
State officials and several women had asked the Ninth U.S. Circuit Court of Appeals to suspend the judge’s preliminary injunction, which bars them from enforcing the law, while they appeal his ruling.
In a split decision, the appeals court denied that request, finding that the state and the women did not show that they would suffer irreparable harm if the injunction stayed in place pending the appeal.