Some popular drug products on the market should have consumers on high alert for possible drug safety risks or defects, according to Miami product liability attorney Tod Aronovitz. In the following round-up of product liability news, he points to recent government actions, as well as one study and a pending lawsuit:
Unapproved Prescription Ear Drop (Otic) Products
The FDA recently announced it is taking action against manufacturers and/or distributors of certain unapproved prescription ear drops—known as otic products—labeled to relieve ear pain, infection and inflammation. These products, frequently given to children to treat ear infections, have not been evaluated by the FDA for safety, effectiveness and quality. They may contain: benzocaine; benzocaine and antipyrine; benzocaine, antipyrine and zinc acetate; benzocaine, chloroxylenol and hydrocortisone; chloroxylenol and pramoxine; and chloroxylenol, pramoxine and hydrocortisone. Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives.
Breathing Issues in Children Under 18 Using Codeine Cough-and-Cold Medicines
The FDA has issued a drug safety communication about codeine-containing medicines to treat coughs and colds in children under the age of 18 because of the potential for serious side effects, including slowed or difficult breathing. Children, especially those who already have breathing problems, tend to be more susceptible to serious side effects. In 2013, the FDA warned against using codeine in children who had surgery to remove tonsils and/or adenoids. In 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat coughs and colds in children under 12. The FDA will continue to evaluate this issue and consider the EMA recommendations.
FDA Finds Patients Taking Onglyza May Have Increased Risk of Heart Failure
Preliminary review data of a drug safety study by the FDA showed that there was an increased risk of hospitalization for heart failure noted in patients treated with saxagliptin or Onglyza. Manufactured by AstraZeneca, Onglyza is a new class of diabetes drugs that regulates blood sugar and insulin levels by inhibiting the enzyme dipeptidyl peptidase-4. In the clinical trial called SAVOR, 16,000 patients using the medication were studied. An FDA advisory panel discussed SAVOR’s findings in April and flagged an increased risk—recommending that Onglyza’s label include information about the potential risk of heart failure. Signs and symptoms of heart failure may include shortness of breath (dyspnea), fatigue, weakness, and swelling in the legs, ankles, or feet.
New Xarelto Lawsuit Flags Potential Bleeding Complications Due to Flawed Clinical Trials
Two plaintiffs have jointly filed a lawsuit against Janssen Pharamceuticals, Johnson & Johnson, Bayer Corporation and their related companies for injury caused by Xarelto, a recent Top Class Actions article reported. Approved by the FDA in 2011, Xarelto is a blood thinner used to treat and prevent pulmonary embolism and deep vein thrombosis, and reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The first plaintiff filed on behalf of his late wife who took Xarelto for six months in 2013 until she suffered a gastrointestinal bleed. The second plaintiff from Arkansas also suffered a gastrointestinal bleed after taking the medication for four months in 2013. The plaintiffs allege that the use of the blood thinner not only causes gastrointestinal bleeding, but they have accused the defendants of knowingly overlooking flaws in their clinical trials in order to promote Xarelto as a safe and effective product.
If you believe you have a legal claim as a result of injury from the use of any of these products, the Florida product liability attorneys and ARONOVITZ LAW can advise you of your legal rights in a free consultation.
ARONOVITZ LAW: Miami Product Liability Attorneys
The Miami product liability lawyers at the personal injury law firm of ARONOVITZ LAW pursue justice for citizens across Florida who have been injured by the wrongful actions or omissions of another individual, government agency, or corporation. We can assist you with civil litigation including consumer class action litigation, whistleblower cases, medical malpractice, product liability, and wrongful death cases.
Contact Miami product liability attorney Tod Aronovitz for a confidential discussion of your case.