Last month, the FDA announced that it would be conducting a safety review of Pradaxa. Pradaxa is a blood thinning drug typically used in patients who suffer from non-valvular atrial fibrillation. The drug is intended to thin the blood to prevent blood clots from traveling to the brain and causing stroke.

Currently the FDA is investigating whether dangerous bleeding in Pradaxa patients is occurring more commonly than should be expected.

While the FDA believes that Pr૚axa provides important benefits, it is urging doctors to closely follow the recommendations on the drug warning label. Patients taking Pradaxa should continue to do so as directed by their doctor and review any concerns or potential warning signs of dangerous side effects with their physicians.

A recent study from the University of Massachusetts Medical School has found a possible link between the use of statin drugs to lower cholesterol and diabetes in postmenopausal women. While the study, published in a recent issue of the Archives of Internal Medicine could not definitively connect an increased risk of diabetes due to statins, this study joins others that have concluded there is a possible link between the potentially dangerous drugs and the disease.

If you take statins and are concerned about your risk of developing Type 2 diabetes then it is important to speak to your doctor about your concerns and about the right treatment for you.

Last week, the results of a new study that looked at the effect of SSRI antidepressants on newborn children were released. The study found that children born to mothers who used SSRIs (such as Prozac and Zoloft) during pregnancy were more likely to be born with pulmonary hypertension or high blood pressure in the lungs. Specifically, women who take SSRIs late in pregnancy were twice as likely to have an infant born with pulmonary hypertension.

Pulmonary hypertension can create difficulties breathing and heart failure. While the study stops short of saying that the SSRIs caused pulmonary hypertension, the researchers are encouraging women to talk to their doctors about their risks and about other possible ways to treat depression during pregnancy.

Recently, the FDA announced that the diabetes drug Actos may be linked to an increase risk of bladder cancer in some patients. Unfortunately, not every Actos user may have gotten the message. If your loved one is taking medication for diabetes, then it is suggested that you ask your loved one if he or she:

• Is taking Actos.
• (If the answer is yes), Is familiar with the FDA’s warning about Actos and bladder cancer.
• Knows the symptoms of bladder cancer.
• Has spoken about the risk of bladder cancer with his or her doctor.

Educating your loved one about the risks of bladder cancer and Actos could eventually save your loved one’s life. Therefore, it is important to take the time to share what you know about the condition with your loved one today.

Last week Vivus, Inc. reported important safety information regarding its weight loss drug Qnexa. Currently, Vivus is seeking FDA approval of Qnexa, a drug that combines topiramate with phentermine.

Prior to approving Qnexa, the FDA is requesting Vivus to conduct an analysis on the safety of topiramate, one of the two main components of Qnexa and the primary ingredient of Johnson & Johnson’s Topamax drug.

According to the Vivus analysis, when topiramate is taken during the first trimester of pregnancy, children are at double the risk of being born with a cleft lip or cleft palate. After studying 15,000 medical claims, Vivus estimates the risk of being born with a cleft lip or cleft palate to be 0.16% for women who used topiramate prior to pregnancy and 0.36% for women who use topiramate during the first trimester of pregnancy.

Vivus is preparing to meet with the FDA again in 2012 regarding approval of Qnexa.