The U.S. Food and Drug Administration has issued a warning about the drug Limbrel. Limbrel is a prescription medication that, according to its packaging, is prescribed to help patients with osteoarthritis. Primus Pharmaceuticals, the manufacturer of Limbrel, marketed the drug as being beneficial for managing the metabolic processes related to this condition.
However, according to the FDA, Limbrel has been associated with 194 adverse reactions. Two of the possible side effects may be life-threatening. Hypersensitivity pneumonitis, as well as liver injuries, have been reported by some Limbrel users. Hypersensitivity pneumonitis is a lung condition in which the alveoli become inflamed.
Of the 194 adverse events that have been reported to the FDA, 57 provided enough information for officials to determine whether they were related to Limbrel. Further, in 30 of the events, enough information was provided so that the administration could implement the causality assessment method of the Council for International Organizations of Medical Sciences. Using this method, officials could determine how likely it was that Limbrel was associated with the serious symptoms reported by patients.
Based on the results of the FDA’s investigation thus far, it recommends:
- Medical professionals who have patients taking Limbrel should tell them to stop taking it immediately.
- Patients who are taking Limbrel should stop taking it and speak with their medical professionals as soon as possible.
Those who take Limbrel and suffer drug-induced liver damage or hypersensitivity pneumonitis should report these symptoms to their medical providers. Both medical professionals and affected patients are encouraged to report any symptoms to the FDA through MedWatch.
Limbrel comes in two dosages: 250 mg and 500 mg. Each contains two different flavonoids, Catechin and Baicalin. Catechin is derived from Acadia catechu, and baicalin is derived from Scutellaria Baicalensis. In addition to flavonoids, Limbrel also contains zinc. These flavonoids have demonstrated an inhibitory effect on pro-inflammatory enzymes lipoxygenase 5, as well as COX-1 and COX-2.
The FDA has been in touch with Primus Pharmaceuticals about Limbrel. The FDA has requested detailed information about Limbrel and is currently reviewing it. The FDA released a statement, saying, “In the interim, the agency is alerting consumers and healthcare providers about the potential impact to health and advising consumers not to use Limbrel. The FDA is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.”
One medical professional noted that many were optimistic that Limbrel would be a viable alternative to NSAIDs for those suffering osteoarthritis of the knees. NSAIDs, which stands for “nonsteroidal anti-inflammatory drugs,” are not recommended for everyone, such as those with an allergy to NSAIDs.
Limbrel was approved and regulated by the FDA after its clinical trial results were reviewed. Limbrel is a medical food, which generally means that it is a plant-derived substance or has some type of bioactive characteristics. The FDA has designated these as GRAS, which stands for Generally Recognized as Safe.
Limbrel was tested in a placebo-controlled double-blind study of more than 200 patients that took place over a 12-week period. An open-label study of 1,067 subjects that took 60 days was also conducted. However, this was a relatively small number of individuals examined under the controlled conditions. Additionally, a long-term follow-up was not conducted.
In 2012, reports of liver failure were noted. There were 4 cases that year, as well as 7 reports of hypersensitivity pneumonitis. These cases were reported from the 270,000 individuals who were exposed to the drug by 2010, which is the equivalent of 2 to 3 cases per 100,000.
Drug Manufacturers Have a Duty to Ensure Their Drugs Are Safe for Consumption
All manufacturers, including drug companies, must take as many steps as possible to ensure their products are safe for the public to use. If it is discovered that a product is not safe and causes consumers harm, those consumers may be able to file a claim for damages.
Generally, in a defective drug claim, the consumer must show:
- The drug injured the consumer.
- The drug is defective.
- The drug’s defect caused the consumer’s injuries.
- The consumer was using the drug as it was intended.
If a consumer cannot prove one of these elements, the claim may fail.
The elements of a defective drug claim also apply to drug injury claims. The consumer must prove that the drug was defective and that it caused injuries.
If a consumer is injured by a defective drug (prescription or over the counter), he should immediately consult with an experienced drug injury attorney. These attorneys are skilled in handling these complex claims and work hard to ensure their clients obtain the largest amount of compensation available under the law. There are deadlines in place that limit how much time a claimant must file a claim; therefore, speaking with an attorney from Parker Waichman LLP as soon as possible is imperative.
How do I Prove That Limbrel Caused My Injuries?
Your drug injury attorney will gather as much evidence as possible to show the extent of the injuries you suffered. Your drug injury attorney will gather documents, interview witnesses, and consult with experts to ensure a strong case is built on your behalf.
Some of the evidence considered in a drug injury case includes:
- Medical records
- Medical bills
- Video footage
- Deposition transcripts
- Expert witness reports
- Company records, such as clinical trial reports
- FDA documents
- Witness statements
Drug injury cases may require the careful examination of hundreds of pages of documents.
How Long Does a Drug Injury Case Take?
The amount of time a drug injury case takes to be resolved depends on many circumstances, such as how many people the drug allegedly injured.
Throughout the drug injury claim, the parties exchange evidence back and forth and attempt to negotiate a settlement agreement. The parties should not attempt to settle the claim until they have all the relevant evidence in the case, which can be a lengthy process. For example, it can take a few weeks or months to gather all the medical records in a drug injury claim.
What Types of Damages Are Available in a Drug Injury Case?
In a drug injury case, the following types of damages may be available, depending on the specific circumstances of the claim:
- Medical costs, such as hospital bills and surgery bills
- Lost wages, if the plaintiff had to take time off from work to recover
- The expense of any future medical care that may be necessary
- Remodeling expenses, such as wheelchair ramps or chair lifts
- Loss of consortium, which compensates family members for the harm their relationship with the plaintiff has endured
- Pain and suffering, which compensates the plaintiff for the physical discomfort he has suffered
- Emotional distress, such as anxiety or depression caused by the incident
If You Have Suffered an Injury Taking Limbrel, contact Parker Waichman LLP Today
At Parker Waichman LLP, our drug injury attorneys are experienced in these complex claims and have achieved outstanding results for many of our clients. We will evaluate your case and, if you retain our services, will devote our resources and talents to your recovery. To receive your free consultation with our experienced legal team, call 1-800-YOURLAWYER (1-800-968-7529).