The recent Amlodipine lawsuit involving generic Amlodipine and Dextromethazine, the generic version of the prescription drug DMAE, was not an isolated event. In fact, it is symptomatic of a much larger problem: the inability of the Food and Drug Administration to regulate the pharmaceutical industry.
The agency allows drug manufacturers to submit drug applications for approval that contains virtually any combination of ingredients they choose, leading to a lack of consistency in the quality of medications on the market.
Amlodipine Lawsuit
One of the most prominent lawsuits involving the use of amlodipine or similar anti-depressants was brought against generic valsartan bacteria with the claim that the product caused a blood pressure medication recall. The FDA did not receive any reports of patient deaths or adverse side effects prior to the recall and identified no contraindications or precautions that should have been taken by patients.
A report from the FDA noted that a patient was diagnosed with congestive heart failure as a result of taking amlodipine. Although there was no causal link to the medication, the FDA received a complaint that the company had not properly notified the FDA of the risk of the combination.
The situation with amlodipine is similar to the one that happened with Losartan lawsuit lawyers.
The company had not provided adequate warnings to patients about the combination of dextrose and amlodipine. As a result, numerous patients became seriously ill and even required hospitalization, leading to the lawsuit.
In the amlodipine lawsuit, the plaintiff was able to prove that the combination caused her to develop serious problems including hypertension, cardiovascular disease, kidney failure, and mental retardation. Furthermore, the FDA failed to conduct any analysis to determine whether the combination of dextrose and amlodipine was safe.
Another case that involves a recall involves the misclassification of stadlan.
Stadlan is also known as Arconic and was manufactured by Freseneway Medical Products. The FDA received reports in 2021 that some of the individuals who had received this high blood pressure medication had died.
Since the FDA failed to conduct a toxicity analysis, it is not clear whether or not the combination of stadlan and amlodipine posed any danger to the patient. There have been no further cases involving these drugs or their combination.
There are many other examples where both amlodipine and stadlan were included in a single product.
For example, amlodipine was distributed together with stadlan to patients who already had a heart condition. Similarly, in a case involving lofexidene, which is known as “the smoking drug,” the manufacturer was able to combine the two medications to create a new prescription drug called vapabalin.
The combination of these two drugs was disastrous for many patients. The plaintiffs in these lawsuits were able to receive compensation for their pain and suffering caused by these tainted medications.
While the FDA is responsible for ensuring that medications are properly and safely distributed, they are not the same entity responsible for determining whether or not they are dangerous.
As an agency within the US Food and Drug Administration, they are prohibited from providing a consumer warning about a recall. They can only issue such a warning if the recall was due to an ingredient or problem with a drug, which has been determined to be unsafe for the public. The FDA will not issue a recall if it believes that there is not a connection between the recalled medication and any potential side effects. Due to the fact that many of these medications are relatively new and have not yet undergone rigorous testing for safety and effectiveness, the FDA cannot determine the extent of the potential hazard posed by the combination of the two medications.
The courts, on the other hand, have the ability to provide much greater protection when it comes to determining whether or not a drug manufacturer was negligent in their actions in providing these medications with known side effects.