It was a perplexing situation when a blood pressure medication was withdrawn from the market after people reported finding the wrong pills in the packaged bottle.
This happened in late August 2018 when Accord Healthcare Inc recalled specific batches of 100-pill bottles filled with Spironolactone tablets USP 25 mg, which were supposed to be containing Hydrochlorothiazide USP 12.5 mg blood pressure medication.
These types of injuries often pose unique challenges, but The Law Offices of Sean M. Cleary can help you if you were harmed by a defective drug.
Spironolactone treats congestive heart failure and liver cirrhosis. The officials of the Food and Drug Administration (FDA) said that the effects of the intake of incorrect medication could be either limited or life-threatening and depend on the individual.
- A few weeks before this incident, numerous blood pressure medications, including valsartan, Irbesartan, and Losartan were recalled because they were found to have an unexpected contaminant called N-nitrosodimethylamine (NDMA), a probable carcinogen. The FDA stated that the presence of NDMA was unexpected and changes in the manufacturing process were speculated as to the reason for the impurity.
According to the U.S. Environmental Protection Agency (EPA), NDMA is a by-product of industrial processes and laboratory studies have shown this to be a dangerous chemical. Chronic exposure to high levels of NDMA is likely to cause damage to the liver. Further, FDA has started investigations regarding the amount of NDMA that was present in the recalled medications and the subsequent effects that might have occurred in patients exposed through medications.
- Recently, on October 26, 2018, the FDA announced the recall of 22 batches of Irbesartan by Aurobindo Pharma Limited. Some of the batches of Irbesartan tablets manufactured by ScieGen Pharmaceuticals were impacted too. Sandoz Inc, the generic division of Novartis has voluntarily recalled Losartan tablets earlier this month because it had chances of containing an impurity called N-nitrosodiethylamine (NDEA), which the International Agency for Research on Cancer (IARC) regarded as a probable human carcinogen.
The patients who are currently being treated with this medication will need to consult their physician before discontinuing its use because the risk of stopping the medication abruptly outweighs the possible risk of developing cancer. It is said that the affected batches of Losartan included 100mg/25mg tablets bearing the lot number JB8912 manufactured by Zhejiang Huahai Pharmaceutical Co. in Linhai, China, and was released to the market only after October 8, 2018. The patients should be proactive and ascertain whether their medication has been recalled by looking at the name of the drug and company mentioned in the prescription label.
The drug manufacturing companies need to evaluate their products thoroughly for safety to obtain approval from the FDA. Despite the scrutiny, many drugs get recalled and labeled as dangerous after being released to the market and used by patients. This eventually directs us to the fact that FDA approval solely does not guarantee consumers a safe drug.
What Does it Mean When a Drug Has a Black Box Warning?
FDA's strictest warning added to the labeling of any prescription drug is the black box warning or boxed warning. A boxed warning is a warning with a black box around it, hence the name, based on clinical or serious animal toxicity data.
What you need to know about the black box warning is:
- The warning is designed to call attention to significant risks or even life-threatening adverse effects.
- Prescription drugs with a black box warning have either caused or are expected to cause a serious adverse event or death.
- The FDA requires the warning to be placed in the package insert so that practitioners can heed the warnings and monitor regularly the patients who are on these medications.
- A boxed warning is implemented in collaboration with the pharmaceutical company that produced the drug - after the FDA confirms the serious risks and depending on the severity of adverse events.
- The warning does not mean the drug should not be used, but it is a means of communication highlighting the drug's risk.
If you have concerns regarding your prescriptions, you should discuss these with your physician.
How Can a Miami Personal Injury Attorney Help With Your Pharmaceutical Claim?
If the use of dangerous prescription drugs hurt you, you would need an experienced and resourceful personal injury lawyer to understand the problems caused by your medicinal regimen, determine the strength of your case, and define potentially liable parties.
Our Miami-based law firm, The Law Offices of Sean M. Cleary is experienced in representing clients who have suffered medication-related injuries throughout the state of Florida.Sean M. Cleary specializes in product liability litigation and has represented clients who have suffered serious adverse events due to the intake of defective medication.
At The Law Offices of Sean M. Cleary, we work with medical experts and develop strong claims to secure maximum eligible compensation from the pharmaceutical companies for any injury or side effect resulting from defective medication.
If you, or your family member, have been a victim of defective medication, both prescription or over the counter drugs, get in touch with our product liability lawyer right away as there are time limits within which a claim has to be filed. We will evaluate your case free of cost and will let you know of the compensation and benefits you may receive. Call us today to protect your right to recovery before legal deadlines expire.