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.
Approved in 2005, Byetta is an injectable medication used to help lower blood sugar levels of people suffering from Type 2 Diabetes. In 2007 the FDA issued a public warning that there were concerns over a possible link between pancreatitis, a condition associated with the development of pancreatic cancer, and the use of Byetta and other incretin mimetic drugs. A 2011 study from UCLA suggested that Byetta might increase the risk of developing pancreatic cancer and thyroid cancer. According to a report published by The Institute for Safe Medication Practices, 612 of the 1,069 cases of pancreatitis, pancreatic cancer, thyroid cancer or hypersensitivity reaction reported to the FDA in 2012 were linked to Byetta.
These concerns escalated in March of 2013 when a study suggested a connection between the use of Byetta and the development of a precancerous condition called pancreatic duct metaplasia. Although the FDA as yet to confirm that patients taking incretin mimetics such as Byetta are in fact at risk of this disease, research on this concern is ongoing. Both the FDA and the American Diabetes Association have requested more testing of drugs like Byetta to determine additional risks. A recent report in the British Medical Journal suggests that risks associated with incretin memtics have been minimized by drug manufacturers.
Over 60 lawsuits involving the use of Byetta and other incretin mimetic drugs such as Januvia and Victoza are underway in U.S. District Court, Southern District of California. On August 26, 2013 the Judicial Panel on Multidistrict Litigation consolidated these cases (Incretins Products Liability, Sales and Marketing Litigation, MDL 252, United States Judicial Panel on Multidistrict Litigation). The first trial conference is scheduled for October 17, 2013.
McNeil Consumer Healthcare, together with the U.S. Food & Drug Association, has implemented the voluntary recall of infant and children’s liquid Tylenol, Motrin, Zyrtec and Benadryl due to concerns over manufacturing deficiencies. According to the announcement published on the FDA website, some of the products might a have higher concentration of the active ingredient than is specified on the label; others might contain inactive ingredients that have not satisfied testing requirements; and others possibly contain small particles that could be harmful to infants and children.
Although the likelihood of serious medical problems is believed to be remote, the FDA is advising consumers to discontinue using the above products. Consumers are being asked to report any adverse reactions to these products to: FDA’s MedWatch Program by fax 1-800-FDA-0178, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Manufactured by Bayer Healthcare Pharmaceuticals, the Mirena IUD was approved by the FDA in 2000 as a contraceptive and later as treatment for heavy bleeding after childbirth. The device is used by more than 2 million women in the U.S. and 15 million women worldwide. Although considered a safe form of birth control, the FDA has received thousands of reports from women claiming they have suffered serious complications from the device. Recent lawsuits allege that women who use the contraceptive are susceptible to the following risks:
- Perforation of the uterine or cervix wall
- Embedment in vaginal tissue
- Pelvic inflammatory disease
- Ovarian Cysts
- Migration out of the uterus which can result in infection or other injuries
Of the nearly 3 dozen lawsuits filed, the primary allegation is perforation of surrounding tissue. According to the lawsuits, Bayer Healthcare Pharmaceuticals knew or should have known about the risks and neglected to provide adequate warnings to the medical community. Plaintiffs allege that the company withheld information about the risks and made false and deceptive representations concerning the safety of the device. Although the FDA has not yet recommended a recall of the Mirena IUD, it appears likely that the manufacturer will be required to alter the warning label to include more comprehensive information about potential risks.
Click here to access the FDA’s description of the Mirena IUD, including side affects and risks.