FDA has warned that the migraine and anti-sizure medication, Topamax (Topiramate), has been linked to birth defects in children of mothers who use the drug during pregnancy. These include cleft lips and cleft palates. 

For more information on the reports see:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245594.htm

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FDA has determined that it will not require a warning on low dose, short term use (14 days or less) over the counter (OTC) proton pump inhibitors (PPIs). PPIs are used primarily to decrease acid in the stomach that can come from heartburn, ulcers or other stomach disorders. Some common PPIs include Prilosec, Protonix, Nexium and Prevacid. 

According to FDA the OTC PPIs are indicated for 14 days or less and are lower doses than at prescription level. If a consumer is taking more than the recommended low dose or is using the PPI for longer than 14 days, he or she should first discuss the risks of osteoporosis and fracture with a physician. FDA is attempting to make healthcare officials aware of the risk for fracture if they are recommending use of the OTC PPIs at higher doses or for longer periods than in the OTC PPI label.

For more information on the news release see PPIFracture at www.fda.gov 

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Diving enthusiasts take note. The Consumer Product Safety Commission and Ocean Technology Systems recalled the $800 Guardian Full-Face diving mask. The mask is black with blue accent colors and the Ocean Technology logo is affixed to the front of the mask.  About 1,700 were sold in the U.S. from September through November of 2010 and involve serial numbers 9051284 through 100070954.

According to the CPSC news release the purge assembly on the diving mask can disengage from the regulator, create a loss of air, and pose a drowning risk to the diver. The company has received one report of a disengaged assembly and that report prompted the recall. 

CPSC warns that consumers should immediately stop using the Guardian Full Face diving masks at issue and notify Ocean Technology for instructions on testing the regulator and returning it for a free repair. 

To see the recall notice, see the link below. 

http://www.cpsc.gov/cpscpub/prerel/prhtml11/11180.html

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In an unanimous opinion, authored by Justice Sotomayor, the United States Supreme Court affirmed the decision of the Ninth Circuit Court of Appeals reversing the dismissal of a securities fraud case against Matrixx Initiatives Inc., et al, the manufacturers of Zicam Cold Remedy. The Court held in part that there was no merit to the Defendant's argument that there was no fraud if they failed to inform investors of the risk of Zicam causing users to lose their senses of smell unless the manufacturer had actual data showing such a risk was statistically significant. If Matrixx had its way the data showing the loss of smell would have had to have first shown there was more than a two-fold risk under statistical review with an acceptable confidence interval. Thus, the collection and epidemiology analysis of the data could have been the subject of months, if not years, of analysis or data mining before investors were told. The Supreme Court rightfully stated that to do so would artificially exclude information that would otherwise be the only reliable indication to an investor that there is something more than the mere existence of adverse reports going on with the product.

This is a significant opinion in favor of investors, in part, because makers of drug products have long tried to convince courts and FDA that the only time they have any duty to act on adverse risk data is when there is a statistically significant placebo-controlled study that shows causation between the adverse event and the drug. Because of the ability to manipulate data in many circumstances, such an approach would rarely result in public knowledge of the risk. The full opinion, Matrixx Initiatives Inc., et al. v. Siracusano, et al., can be read on the Supreme Court website at:

http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf

 

 


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