Monthly Archives: December 2007

FDA Steps Up Warnings on Certain Epilepsy Drugs

The FDA has strengthened its warnings on the epilepsy drugs Carbatrol by Shire PLC, Tegretol by Novartis AG, and Equetro by Validus Pharmaceuticals Inc. Carbamazepine is the other name for the drug which is used to treat epilepsy, bipolar disorder, and nerve pain. The drug can cause a rare but potentially life threatening skin disease. The disease manifests itself in toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, and itching. In its statement, the FDA pointed out that those of Asian ancestry should be tested before starting any treatment regimen with carbamazepine since their risk of contracting the skin disease is 10 times higher than in the general population.

Mayo Clinic Study Links Anemia Drugs with Leukemia

A recent Mayo Clinic study has shown a potential link between an increased risk in leukemia and the anemia drugs Aranesp, Epogen, and Procrit. According to Dr. Ayalew Tefferi, Mayo Clinic hematologist, “While we cannot take these findings as an absolute, at the same time, they cannot be ignored, treatment decisions regarding the use of anemia drugs in patients with primary myelofibrosis should carefully be evaluated.”

butyl benzyl phthalate linked to an Increase in Breast Cancer

Butyl benzyl phthalate or BBP is a man-made chemical that is used in millions of products from lipstick and nail polish to plastics. Consumers come into contact with the chemical on a regular basis. Yet, BBP has been linked to an increased risk of developing breast cancer. Previously, BBP has been associated with birth defects, kidney problems, and infertility. The chemical mimicks the female hormone estrogen. Health advocates have called on the cosmetics industry to ban the chemical which is used to make products glossy. The plastics industry uses the chemical to make plastic softer. However, the health risks associated with BBP far outweigh any consumer advantage.

Medtronic Under Federal Investigation for Payments to Doctors

Medtronic is under federal investigation for payments to physicians concerning its Sprint Fidelis defibrillator. The Justice Department has asked Medtronic to provide it with information about any payments it may have made to foreign doctors in violation of the U.S. Foreign Corrupt Practices Act.
A Senate panel is investigating the FDA’s monitoring of medical device components including defibrillators. Medtronic has had difficulty with its Sprint Fidelis defibrillator leads after complaints surfaced that the leads were fracturing causing abnormal or malfunctioning of the electrical impulse sent to the heart to restore a normal rhythm.

Bed Wetting Drug Linked to Potentially Lethal Seizures

A drug used to curb bedwetting in children has been linked to potentially fatal seizures. the FDA has issued a warning concerning desmopressin intranasal formulations which are no longer allowed to treat bedwetting. Desmopressin can lead to hyponatremia, an abnormally low level of sodium in the blood. The drug is designed to limit the amount of water eliminated in urine. In issuing the warning, the FDA stated that it has received 61 reports of seizures including 2 deaths.

Navy Priest Faces Sexual Misconduct Charges

A Navy priest who tested HIV positive stands accused of sodomy, aggravated assault, indecent assault, fraternization and conduct unbecoming a military officer. His court martial will be held at Marine Corps Base, Quanitco, Va. Lt. Cmdr. John Thomas Matthew Lee, 42, was ordained a Catholic priest for the Archdiocese of Washington DC in 1993. He was on loan to the Archdiocese for the Military Services. More than 25 priests from the Archdiocese for the Military Services have been accused of sexual abuse in the last 30 years.

Catholic Church in Davenport Settles Sex Abuse Claims for $37 Million

The Catholic Diocese of Davenport has agreed to settle 156 claims of sexual abuse by priests for $37 million after an intense 4 day mediation in Chicago. The priest sexual abuse claims date back as far as the late 1930’s. Some of the settlement will be put aside for future claims. The Diocese of Davenport is the last of five dioceses and archdioceses in the United States to reach a settlement after filing for bankruptcy. In September 2007, the Archdiocese of Portland in Oregon settled its abuse claims for $51million with an additional $20 million set aside for future victims. The Dioceses of Spokane and Tuscon settled claims for $48 million and $22 million respectively.
However, the Davenport agreement is unique in that the survivors of sexual abuse will be able to speak about their experiences in church as well as to the press. This is perhaps a major victory in putting an end to the sexual exploitation and abuse of children in the Catholic Church.

Avastin Questionable as a Breast Cancer Drug

In considering whether to allow Genentech to market Avastin as a breast cancer drug, the FDA is now saying that the drug has not proven to prolong the lives of those with advanced breast cancer. Furthermore, Avastin carries with it some serious side effects including cardiovascular problems, bowel perforations, and possible death. Avastin was approved by the FDA to treat colon cancer in 2004.