Pharmaceuticals Attorneys Blog

Published on: September 28, 2023

FDA Advisory Panel Determines that Phenylephrine Doesn’t Get Rid of Congestion

woman-698964_1280-e1695661666719 Phenylephrine is an ingredient in popular oral decongestants branded as Vicks Nyquil Sinex Nighttime Sinus Relief, Sudafed PE, and Benadryl Allergy Plus Congestion. It was believed that the drug worked to reduce blood vessel swelling in the nasal passages, and that this got rid of congestion. These decongestants generated nearly $1.8 billion in sales in 2022. A Food and Drug Administration (FDA) advisory panel has advised that data shows over-the-counter cold and allergy medications that contain phenylephrine don’t effectively eliminate nasal congestion. A unanimous vote by the panel declared that the drug is not useful.

Call Moll Law Group About Dangerous Drug Claims

The FDA only started to review over-the-counter cold medicines in 1976. Over the last 30 years, Florida pharmacy professors have pressured the FDA to do something about the efficacy of phenylephrine. Back in 1993, Dr. Leslie Hendeles wrote a paper published in a medical journal that phenylephrine didn’t work because it was destroyed in the stomach and never made it to the bloodstream. Further research over the years determined the drug was not any better than a placebo. Pandemic legislation changes FDA staffing and procedures so that they’re more in line with the rules surrounding prescription drugs, and this caused the FDA to produce an 89-page review.

While the FDA makes final decisions about drugs, they sometimes use advisory committees to give them advice and recommendations. FDA considers a committee’s advice and recommendations when deciding; in this case the advisory committee’s opinion was based on the FDA’s 89-page review.

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Published on: August 23, 2021

FDA Notifies Amazon It Is Distributing Defective Drugs

By Moll Law Group

In spite of its efforts to stop the distribution of dangerous weight loss and sexual enhancement products, the Food and Drug Administration (FDA) continues to discover weight loss and sexual enhancement products that violate the federal Food, Drug, and Cosmetic Act at various online stores. Consumers in Chicago and elsewhere should be wary of purchasing these types of products online.

The FDA has warned consumers about dangerous products available at online retailers for a decade, but in spite of efforts to improve safety in these spaces, violations persist. On July 26, 2021, the FDA issued a letter to let Amazon know that it was distributing weight loss and sexual enhancement products that violate the federal Food, Drug, and Cosmetic Act. The distributed products include hidden ingredients that could have harmful medical consequences.

The FDA sampled 26 products it bought on Amazon. It also sampled 25 products it bought on eBay. Alarmingly, the FDA found that all 26 of the drugs bought on Amazon contained undeclared active ingredients. 20 of 25 products purchased on eBay also did. None of the potentially harmful ingredients in these products is declared in the product labeling so that consumers know to seek physician supervision and advice with regard to them. For instance, an FDA lab analysis confirmed that X Rated Honey for Men includes tadalafil, which is the active ingredient in the erectile dysfunction drug Cialis. Likewise, analysis found tadalafil, the active ingredient in the FDA-approved prescription drug Cialis, in Adam’s Secret Extra Strength 2000 sold through online retailers.

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Published on: April 6, 2020

The Food and Drug Administration Pulls Zantac from Pharmacy Shelves

By Moll Law Group

FDA Recall Earlier this week, the U.S. Food and Drug Administration issued a news release requesting manufacturers to withdraw all products containing the popular heartburn drug, ranitidine, the active ingredient in the medication, Zantac. The order applies to both prescription and over-the-counter medications. In light of the ongoing COVID-19 national emergency, those who have medicine containing ranitidine on hand are being asked not to return the product to the pharmacy, as is typically recommended. Instead, the FDA is recommending the medication be destroyed according to the disposal suggestion contained in the medication guide or package insert. All formulations of ranitidine are impacted, including pills, injections, and compounded medications that include ranitidine.

The recent recall is the latest step in an escalating investigation surrounding a contaminant known as N-Nitrosodimethylamine (NDMA), which is commonly found in ranitidine. Through its research, the FDA found that the impurities in some ranitidine products increase over time when stored at higher temperatures, potentially resulting in dangerous levels of NDMA.

In its official statement, the FDA explained that it didn’t see unacceptable levels of NDMA in the many samples they tested. Nevertheless, since they did not know how or for how long the product might have been stored they decided that it should not be available to consumers and patients unless its quality could be assured.

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Published on: October 17, 2016

FDA Issues Warning About Potentially Fatal Baby Teething Products

By Moll Law Group

The U.S. Food and Drug Administration recently issued a warning indicating that benzocaine, an anesthetic commonly used in over-the-counter teething gels for infants as well as liquid medications, can cause serious injuries and even death. Commonly found in products like Anbesol or Baby Orajel, the local anesthetic has in some cases led to a serious condition known as methemoglobinemia. This condition reduces the quantity of oxygen that travels through the patient’s bloodstream. Parents who have products containing benzocaine are promptly advised to stop using them on children younger than two and should seek a consultation with a health care official immediately.

In many instances, parents and other consumers presume that products marketed as homeopathic remedies are safe and pose fewer risks than pharmaceuticals and similarly derived products. A maker of such products, Hyland’s, which offers a benzocaine teething product, announced that it has discontinued making such products. According to a statement, the company stopped manufacturing the products due to the FDA’s warning. Major international drug store Walgreen’s has also discontinued its offering of products containing benzocaine.

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Published on: October 7, 2016

Cancer Patients File Lawsuit Against Taxotere Maker After Suffering Permanent Hair Loss

By Moll Law Group

A substantial number of breast cancer patients in the U.S. have received treatment using a drug called Taxotere, which is manufactured by a company called Sanofi. Unlike other cancer drugs that required weekly appointments, Taxotere required treatment only once every three weeks. For cancer patients who are still busy juggling other commitments, this was an appealing option. In addition to being used to treat breast cancer, the drug has also been employed to treat stomach cancer, non-small cell lung cancer, neck cancer, head cancer, and metastatic prostate cancer.

Soon after the drug became a popular treatment, numerous reports surfaced from patients claiming that they suffered permanent hair loss as a result of taking the drug. According to the slew of lawsuits that were filed after the reports became widespread, the plaintiffs largely alleged that the drug maker failed to provide appropriate warnings and disclosures regarding the drug’s potentially disfiguring side effects. Other allegations included failing to conduct appropriate investigations into the safety and potential side effects of the drug, concealing information from consumers, and failing to fully and accurately communicate the severity of the dangers that could arise from taking the drug.

In addition to the adverse reaction reports that surfaced, studies have shown that nearly 10 percent of breast cancer patients who took Taxotere suffered alopecia that persisted for 10 years or more. This caused a variety of injuries and consequences, including emotional distress, pain and suffering, social anxiety, and disfigurement.

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Published on: August 1, 2016

FDA Increases Warnings Associated with Fluoroquinolone Antibiotics, Including Cipro and Levaquin

By Moll Law Group

The U.S. Food and Drug Administration recently issued a new warning increasing the cautions associated with fluoroquinolone-based medications, concluding that this class of antibiotics may be too strong to address bronchitis, sinus infections, and urinary tract infections. The FDA has received a number of complaints regarding the drugs and has concluded that dangerous side effects include disabling and potentially irreversible tendon, muscle, joint, nerve, and central nervous system pain. The warning label for these drug products has been updated to reflect these new risks.

The agency also stated in its warning that fluoroquinolones should only be prescribed to patients who have no other medical recourse for acute bacterial exacerbation of chronic bronchitis, uncomplicated urinary tract infections, or acute bacterial sinusitis. More specifically, health care professionals should immediately stop prescribing these medications for patients who have any of these conditions and support any serious adverse reactions as soon as possible. The current Boxed Warning for fluoroquinolone medicines applies to a number of conditions like tendon rupture, myasthenia gravis, and tendinitis, as well as peripheral neuropathy and a variety of other conditions.

Patients who have been injured as a result of taking dangerous pharmaceuticals can file a product liability or negligence claim against the drug manufacturer. The FDA requires drug manufacturers to comply with extensive regulations regarding the development, testing, approval, and marketing of new drugs. In many instances, companies that manufacture and sell dangerous pharmaceuticals have failed to comply with some of the testing requirements or even hidden information from the FDA about adverse side effects associated with the drugs when seeking approval.

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Published on: July 11, 2016

Philadelphia Jury Awards $70 Million Verdict in Risperdal Breast Growth Case

By Moll Law Group

A Philadelphia jury recently returned a verdict awarding a 16-year-old teenager who suffered injuries after taking Risperdal $70 million in compensation. The manufacturer of the drug is Johnson & Johnson, a major international pharmaceutical and health care products company. According to the teenager’s complaint, Johnson & Johnson failed to provide appropriate warnings with the drug that it could cause him to grow breasts, referred to in the medical community as gynecomastia. According to his complaint, the plaintiff started taking Risperdal when he was five years old to address a psychiatric disorder.

The plaintiff also alleged that Johnson & Johnson intentionally prevented doctors and health care professionals from seeing the adverse results of a study about Risperdal that showed it could cause abnormal breast growth in boys.

Risperdal is an antipsychotic medication used to treat a number of mental disorders like bipolar disorder, schizophrenia, and irritability in autism patients. Signs of gynecomastia include puffy nipples, enlarged nipples, painful breasts, nipple discharge, and breast growth. The results of gynecomastia in boys can be devastating, resulting in serious emotional and mental pain while also frequently requiring a mastectomy to remove the breast growth.

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Published on: July 5, 2016

Moll Law Group Files First Lawsuit Against AstraZeneca For Injuries Sustained from Nexium Use

By Moll Law Group

Moll Law Group has filed its first lawsuit against the maker of Nexium, AstraZeneca, on behalf of a Tennessee resident who suffered severe and life-threatening injuries after being prescribed and taking the drug Nexium. Filed in the Western District of Tennessee, the complaint alleges that the defendants knew or should have known that Nexium poses a serious risk of kidney injuries and that the drug maker failed to provide adequate instructions regarding the potentially life-threatening consequences that could result from the use of the drug.

The plaintiff started taking Nexium in 2003 and continued using it until 2008, when he was diagnosed with a severe and drug-induced case of Acute Interstitial Nephritis following a biopsy. As a result of his condition, he was required to undergo dialysis three times a week and is awaiting a kidney transplant.

Nexium is a type of proton pump inhibitor (PPI) that is used to decrease the amount of acid that the stomach produces. This type of drug is commonly used to treat gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD). Originally approved under the name Losec in 1988, Nexium is a second-generation PPI drug and was intended to be an improvement on the first-generation version, commonly referred to as Prilosec.

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Published on: June 20, 2016

Fluoroquinolone Antibiotics Linked to Aortic Aneurysms, Achilles Tendon Ruptures, Detached Retinas, and Fatalities

By Moll Law Group

Recently, a rash of cases has sprung up involving fluoroquinolone (FQ) antibiotics. Marketed under a variety of names like Cipro, Levaquin, or Avelox, these drugs are used to treat a wide variety of infections. Some sources estimate that roughly 26 million Americans are prescribed FQ antibiotics each year for a wide range of ailments, including pneumonia, urinary tract infections, and more.

According to a Consumer Report, the drugs may cause some serious side effects like aortic aneurysms, nerve damage, or dissections. As the largest blood vessel in the human body, damage to the aorta can cause serious implications for a patient’s health, such as strokes or heart attacks and even death in some serious cases. A dissection happens when the aortic walls deteriorate, which permits blood to seep into the outer layers of tissue. An aneurysm, on the other hand, is a bulging or enlarged part of the aorta. In many situations, these aneurysms have no symptoms and are incredibly difficult to identify. It is often not until the aneurysm bursts that the victim can tell something is wrong. Once it bursts, the victim has a 50 percent chance of surviving the event. For either an aneurysm or an aortic dissection, surgery is often required as well as a lifetime of additional medical treatment and observation.

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Published on: June 10, 2016

First Bellwether Trials in Xarelto Multi-District Litigation Scheduled for Early 2017

By Moll Law Group

The first batch of cases in the Xarelto multi-district litigation are set to go forward in early 2017. Situated in the Eastern District of Louisiana, the multi-district litigation includes numerous cases from plaintiffs alleging that they suffered serious injuries as a result of taking Xarelto, an anti-coagulant drug manufactured by Johnson & Johnson. A multi-district litigation, or MDL, is similar to a class action in that multiple claims are grouped together when there are sufficient similarities. Unlike in a class action, however, the plaintiffs in an MDL maintain their status as separate cases, and each plaintiff must still prove his or her individual case. Damages are not awarded to the class in general but are awarded to each plaintiff depending on the strength and merit of each individual case.

In early 2017, about four so-called bellwether cases will be tried. A bellwether case is a term used in MDL actions to describe the initial test cases that are litigated in the action. These cases typically represent common factual scenarios and damages suffered by the broader group of cases in the MDL. The outcome of these bellwether cases will serve as guidance for the parties as they negotiate a global settlement of the claims. The first two cases will be tried in Lousiana, with the third trial taking place in Mississippi and the final bellwether trial for 2017 taking place in Texas during late spring 2017. These dates are tentative and could be revised or canceled during the coming months as the parties perform discovery and prepare for the trials.

The drug was intended to serve as an alternative to Warfarin and was initially prescribed in cases involving patients who received knee surgeries or hip replacements. It was also prescribed as a way to fend off deep vein thrombosis and to prevent strokes in patients experiencing atrial fibrillation. A number of reports quickly arose indicating that patients suffered serious complications after taking Xarelto. As a result, the U.S. Food and Drug Administration issued multiple black box warnings for the drug.

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