Do you remember the fen-phen debacle in the late 90’s? The Food and Drug Administration (FDA) found that the popular weight loss drug caused serious hear problems and pulled it from the market. Later, the weight loss drug Meridia (sibutrimine) was found to also cause heart problems and could be to be potentially fatal.
These two highly publicized events in weight loss drug history has made the FDA gun shy about the approval of weight loss drugs. Even though there are tons of herbal weight loss remedies that are barely regulated by the already over worked and under funded federal agency, only a couple on the market have actually been given the FDA’s seal of approval. One of these drugs is called Qnexa, produced by pharmaceutical Vivus, one of the smaller drug developers in the scheme of things.
Qnexa and the Heart
The FDA generally approves a drug, any drug, based on review of trials and studies paid for by the developing drug company. The FDA doesn’t have the funding to full test each drug on their own and independent studies are generally not conducted until after the drug has hit the market. Independent studies are mounted unless healthcare professionals or FDA officials have received complaints from patients prescribed the the drug.
Well, the complaint came in and learning from the past about dragging their feet on past obesity drugs, the FDA said that Qnexa was effective at helping people lose weight, but the raised concerns about possible long-term side effects such as birth defects and an unknown impact on the heart.
Now the FDA has opened up a review for the drug for a second time after previously being rejected by the agency in 2010. The agency posted a review of Qnexa on its website today in advance of an advisory panel meeting on Wednesday. The review of the drug includes two-year clinical data rather than one year’s worth of data that was reviewed in 2010.
In the review the FDA compares the drug to defunct Meridia by saying, “A previous example of an obesity therapy, sibutramine, which increased heart rate and blood pressure, was found to be associated with a small but statistically significant increase in the incidence of major cardiac events. In contrast, the small heart rate increases associated with QNEXA occurred in conjunction with significant decreases in systolic and diastolic blood pressure.”
Vivus will face the agency’s endocrinologic and metabolic drugs advisory committee. This panel is comprised of non-FDA medical experts who are supposed to have little to no financial or experiential stake in the drug or its manufacturer. They are being asked to mull over a series of questions including whether the “overall benefit-risk assessment” supports approval of Qnexa.
The FDA posted a notice today that there will be a Qnexa public web event on February 22nd, 2012. The submission date for the public to post questions is February 7th. “But, the date for submission is already passed!” you might say…we did too. The FDA does these unscrupulous things sometimes.
The FDA gives a series of recommendations in their 166 page assessment of the drug and they recommend that the drug stay on the market. The panel votes independently of the recommendations, but since FDA officials often choose to stack panels with experts who are rife with conflicts of interest, more times than not, they get their way.
Qnexa and Birth Defects
To understand the birth defect danger of Qnexa, you need to understand that it is a controlled-release formulation that combines low doses of two older drugs. It combines the stimulant phentermine (the “phen” in fen-phen), topiramate (aka Topamax), which is intended to treat seizures, but has also been found to increase the sense of feeling full.
In 2010 the FDA rejected Qnexa and asked Vivus for an assessment of the drug’s potential to cause birth defects and for evidence that the product doesn’t increase the risk for major adverse cardiovascular events. Studies of topiramate have given a clear connection to an increased birth-defect risk.
The FDA said exposure to topiramate in pregnancy “is likely to be associated with a two- to fivefold increased prevalence of oral clefts.” Otherwise known as “cleft palate.”
Vivus initially proposed limiting use of the drug to men, as well as women of nonchild-bearing age. But Vivus said the FDA asked the company to develop a plan to limit use by pregnant women.
Vivus predicts that, “QNEXA will be available with a risk mitigation program designed to inform prescribers, pharmacists, and patients about the potential serious risks of fetal exposure to QNEXA during pregnancy.”
Defective Drug Attorneys
If you or a loved one has taken Qnexa to lose weight and found that you have run into unexpected heart complications or your newborn child was born with a birth defect as a result of taking the drug, you need council of a good attorney. Phillips Law Firm is a team of experienced defective drug attorneys with a proven track record of successful defective drug litigation. If you or a loved one have experienced serious injuries or death due to the side effects of a generic drug call us today for a free consultation and to find out your legal rights.