On September 23, 2013 the FDA published the W.S. Badger Company’s voluntary recall of all lots of 4-ounce SPF 30 baby sunscreen lotion and one lot of its 4-ounce SPF kids sunscreen lotion after tests revealed microbial contamination. The products were discovered to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungus. Badger is a New Hampshire based company that has been manufacturing natural and organic body care products since 1995. As many a 30,000 tubes of the recalled sunscreen has been sold in the U.S. and Canada. It is the Number one selling all natural sunscreen in the U.S.
Although there have been no reports of adverse reactions to the sunscreen, possible risks associated with the contaminants include the following:
Pseudomonas bacteria: can cause skin rash and ear infections and is especially threatening to people with weakened immune systems. Severe illness can develop if the bacteria enters the bloodstream.
Candida parapsilosis: a fungus that can cause mild skin infection and severe infection if it enters the bloodstream.
Acremonium fungican: can lead to infection if it enters the bloodstream through broken or injured skin.
The company founder and chief executive, Bill Whyte, stated that the sunscreens passed all pre-sale tests but routine re-testing revealed that “several lots had been compromised.” Consumers are being advised to return the products to the original place of purchase for complete refund or contact Badger directly at 1-800-603-6100 or email@example.com.
See the FDA website to view the recall announcement, the complete list of lot numbers affected by the recall, and information on where to report adverse events related to the sunscreen products.
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.
In a May 1, 2013 press release Takeda Pharmaceuticals announced that the trial court judge granted the defendant’s motion for non-suit. The ruling nullifies the April 26th jury verdict.
A Los Angeles Superior Court jury awarded $6.5 million to the plaintiff Jack Cooper in the first trial involving the diabetes drug Actos (Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535). The jury found Takeda Pharmaceuticals liable for the failure to warn patients that Actos could cause bladder cancer. The verdict awarded $5 million in compensatory damages to Jack Cooper and $1.5 million to his wife. As many as 3000 similar lawsuits are pending in the United States.
According to the attorney representing Cooper, the Japanese drug company was aware of possible links between Actos and bladder cancer as early as 2004. However, the company waited 7 years before reporting these findings to U.S. regulators. In 2011 Actos was removed from the market in both France and Germany after studies revealed that some patients using Actos have increased risk of developing heart problems and bladder cancer.
In 2012 the British Medical Journal reported that patients who use Actos for 2 years are twice as likely to develop bladder cancer. In the same year the Canadian Medical Association Journal published the results of a study showing that users of Actos have a 20 percent increased risk of developing bladder cancer. Canada has since removed Actos from the list of approved medications.
A “black box” warning, the strongest of the FDA warnings, informing users that Actos is linked to congestive heart failure was added to the label in 2007. In 2011 an FDA Safety Announcement informed the public that the use of Actos for more than one year might result in “increased risk of bladder cancer”. The announcement required the drug manufacturer to add this warning to the drug label.
In response to FDA demands, Takeda launched a ten year study addressing the long term risk of bladder cancer associated with Actos. Data from the first five years of the study showed that patients taking the drug for over a year have a 40 percent higher risk of developing bladder cancer. The study was completed in 2012 and the full results should be available sometime in 2013.
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.