Dangerous Drugs

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If you are sick or need medication to control an existing condition, your natural instinct is to trust your doctor and the medication they are prescribing you. Sometimes, however, that medication causes severe adverse reactions, sometimes leading to death. When that happens, you are certainly looking for answers. Our experienced dangerous drug attorneys here at Malloy Law Offices are skilled with litigating against insurance companies, healthcare facilities, and medical professionals to obtain justice for our clients. If you have suffered as the result of being prescribed a dangerous drug, contact us today for representation.

How Drugs are Regulated

When a pharmaceutical company is developing a new drug, they must go through a rigorous testing and approval process set by the Food and Drug Administration (FDA). Manufacturers must also submit the results of their own safety testing. When they are first beginning the human testing process, an Investigational New Drug Application must be submitted to the FDA. This report contains all data from their animal testing, laboratory testing, toxicity data, information regarding manufacturing, study protocols, any data from previous human research, and investigator information. The FDA then assembles a review team made up of a pharmacologist, pharmakineticist, project manager, medical officer, statistician, microbiologist, and chemist. Each team member will review their portion of the new drug, and within thirty days review the original IND submission. If they give their approval, the drug will move onto clinical trials.

If all research is positive, the pharmaceutical company can then file something called a New Drug Application (NDA), which is an application to market the drug. The NDA must include information regarding safety updates, labeling, information regarding drug abuse, patent information, data from any international study that had been conducted, compliance information from institutional review board, and directions for use. If the NDA is complete, the FDA review team has six to ten months to make a decision on whether or not to approve the drug. If it is approved, all individual reports that have been made by the review team get assembled into one action package, which now serves as the record for FDA review.

Black Box Warning

A black box warning is the warning put on drug packaging that describes all serious and potentially fatal adverse effects the drug may cause. The FDA may order a pharmaceutical company to include these warnings on their packaging if the potential effects are serious enough. This warning also helps those who may consume the medication determine whether the benefits outweigh the risks. Prescribers may also use this black box warning to determine whether that is the correct drug to prescribe a patient based on warnings, potential risks, and anything the patient consumes that may interact with the drug or serve as a catalyst for adverse side effects, including previous medical history and conditions a patient may be pre-inclined to having develop.

Difference between Market Withdrawal and Drug Recall

When a manufacturer decides to withdraw from the market, there may be several reasons. They may have discovered minor violations that do not require legal action from the FDA, or from a business perspective, lack of sales may be driving product revenue down. Instead of recalling the product, they will simply cease production or distribution, which gradually removes it from the market as supply dwindles.

A drug recall, on the other hand, is a much more serious matter that can either take place as the result of the manufacturing company FDA making the decision. Certain criteria have been met to necessitate partially or completely removing the drug from the market, including contamination, mislabeling, misbranding, and under-warning of adverse side effects, as well as others.

Recall Classifications

When a drug is recalled either by the FDA or the manufacturer themselves, there are three levels of classifications it can fall under. The most severe type is called a Class I recall. Class I recalls indicate that either having exposure to or using the drug will cause adverse reactions or potentially even death. Class II recalls are less severe, in that the adverse side effects from consuming the drug are usually temporary or reversible. Class III recalls are the least severe. Typically, adverse side effects are unlikely to occur with drug usage, but may potentially do so.

Recall Process

The recall process begins with identifying the problem with the drug. If the FDA decides after review that a drug needs to be recalled, it can be one of two ways, mandatory or voluntary. If the manufacturer is recalling their own product, then they must submit all information to the FDA, including relevant drug information, a minimum of two drug samples (fully packaged), and a description of the problem, its discovery, and the reason why the problem occurred. The FDA will then conduct a Health Hazard Assessment to determine the level of recall classification. Once the recall has been completed, the drugs will either be repackaged with the appropriate label warnings and branding, or they will be destroyed in a controlled environment.

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Common Dangerous Drugs

Some of the most commonly known dangerous drugs are ones that are prescribed by medical professionals every day. They are used to treat a number of different conditions, from type 2 diabetes to depression. Below is an abbreviated list of the drugs, their manufacturers, and any adverse effects or even recalls they have been part of.

  • Risperdal: Risperdal is an anti-psychotic drug manufactured by Johnson and Johnson. It is used to treat conditions such as psychosis, bipolar disorder, and schizophrenia, but unfortunately has very serious side effects. Due to misbranding for unapproved uses, as well as downplaying risks and paying kickbacks to doctors and Omnicare, Johnson and Johnson agreed to pay over $2.2 billion to resolve criminal and civil investigations against the company in 2013. This is one of the largest penalties ever brought against a company for healthcare fraud.
  • Pradaxa: Pradaxa is an anti-coagulant, or blood thinner, that is manufactured by Boehringer Ingelheim for conditions such as atrial fibrillation. Its competitors are Coumadin and warfarin, both anti-coagulants that require strict monitoring and diet modifications. Unlike either, Pradaxa allows for much more freedom in diet and does not require weekly blood tests. However, it is also the drug most commonly linked to complications and deaths through serious bleeding.
  • Invokana: Invokana is manufactured by Janssen Pharmaceuticals, a division of Johnson and Johnson, and has been used to treat type 2 diabetes. Unfortunately, it has also been shown to cause diabetic ketoacidosis in patients with type 1 diabetes as well those who have type 2, which is a life-threatening condition that increases the acidity of the blood.
  • Lipitor: Lipitor is a medication commonly prescribed for monitoring cholesterol levels. Manufactured by Pfizer, its adverse effects include, shockingly enough, type 2 diabetes, liver damage, and memory loss. Lawsuits against Lipitor include failure to warn about dangers and label warnings lacking information regarding the risks for type 2 diabetes.
  • Xarelto: this is another anti-coagulant, manufactured by Johnson and Johnson and co-marketed by Bayer, also meant to replace warfarin and Coumadin. Like Pradaxa, there is less restriction when a patient uses Xarelto. Problems arose when patients taking it began experiencing internal bleeding. Unlike warfarin and Coumadin, Xarelto has no antidote. This means that if someone is experiencing internal bleeding and they are using Xarelto, there is a much higher chance that bleeding will be uncontrollable and they could die.
  • Talcum Powder: although talcum powder is not a traditional drug like the others listed above, it has gained heavy media attention through the ongoing lawsuits with one of its manufacturers, Johnson and Johnson, over alleged cases of ovarian cancer. Women who have used talcum powder consistently over years in their undergarments or around their genitals may be at a higher risk for developing ovarian cancer, as the talc particles may travel up into the ovaries. However, data is unclear as to whether talcum powder definitively causes ovarian cancer, though there is some suggestion of a possible increased risk.

Contact an Experienced Dangerous Drugs Attorney

If you or a loved one was prescribed a medication that then led to severe adverse effects, or even death, contact a highly skilled dangerous drugs lawyer as soon as possible. They will go over all medical records and product information to determine whether the manufacturer misbranded, mislabeled, or under-reported risks, and fight to get you the compensation you deserve. Call Malloy Law Offices today for your free consultation regarding your case.

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