Philadelphia, PA (PRWEB) August 24, 2012
When the Food and Drug Administration (FDA) approved the weight loss pill Qsymia on July 17, it prompted the Anapol Schwartz law firm to form an ongoing review of news and outcomes for the drug. The two main ingredients in Qsymia are topiramate and phentermine. Studies have shown that topiramate, which goes by the brand name “Topamax”©, increases the risk of birth defects* and phentermine has been associated with heart problems and lung disease.
The FDA assigned Qsymia to the Pharmaceutical Pregnancy Category X, which means the drug has a demonstrated ability to produce fetal abnormalities.** Women of childbearing years may not be prescribed the medicine because topiramate, commercially known as Topamax, has been linked to birth defects such as cleft lip and cleft palate.
But Topamax, traditionally prescribed for patients with seizures or migraines, is a Class D Pregnancy Category.*** In other words, it’s OK to prescribe Topamax to women of childbearing years despite the risk for birth defects. This confusing situation can hurt children.
Topamax’s pregnancy classification means that human data indicates a risk, but the benefit of avoiding a seizure may outweigh the danger of a birth defect.**** A seizure can result in serious injury or death. The benefit-risk calculation for women with migraines is less clear.
The potential for confusion abounds in this situation and it’s only made worse by the fact that this marks the second time a drug has been combined with phentermine. The combination medication of fenfluramine and phentermine, commonly known as Fen-Phen, was a popular weight loss medication until it was recalled in 1997.***** Researchers found Fen-Phen caused damage to heart valves in as many as one in three users, and about 18 million prescriptions were written for the drug. In the past, Anapol Schwartz represented hundreds of victims of Fen-Phen, and now we represents kids who were born with cleft lip, cleft palate and other deformities we believe is related to the use of Topamax.
Phentermine by itself is known to cause Primary Pulmonary Hypertention (PPH), a frequently fatal lung disease, in what the company calls “rare cases.” Onset symptoms of PPH include shortness of breath, chest pain or angina, fainting, or swelling of the lower extremities.
Add to the risk of fetal harm and lung disease the fact that the diet pill does not produce substantial results. After one year of risk, dieters on the drug only lost 10 percent of body weight compared to those on placebos who lost two percent.******* Considering that the indication for prescription is a body mass index of at least 27, the risk-reward ratio is questioned by many. Even if the drug was as successful as claimed, users would remain overweight.
“We’re concerned that with the urgency to bring a weight loss pill to market, someone is going to get hurt,” said Jim Ronca of the Anapol Schwartz law firm in Philadelphia. “After the Fen-Phen debacle that seriously injured thousands of people and the withdrawal of Meridia from the market, we just have to come up with a better system to prevent people from serious injury. While the FDA does its best to assure safety with pre-market approval, the number of people tested is very small and much less diverse than the public at large. We have seen many cases of a drug being approved as “safe and effective” only to be withdrawn later because it caused injury and death. A big part of our practice is representing people who have been injured or the families of those who have been killed in this way. ”