Drug Injury Lawyer Blog

The US Food and Drug Administration (FDA) has strengthened its warning about the risk of heart attack and strokes caused by both prescription and over-the-counter (OTC) anti-inflammatory drugs. The drugs at the heart of the FDA’s warning include common pain relief medications such as Advil and Aleve, and consumers should be wary of increased risks associated with use of these drugs.

FDA Strengthens Warning on use of Anti-Inflammatory Medication

The FDA had already issued a prior warning about the risk of heart attack and stroke associated with use of anti-inflammatory medications, but after further research the agency has decided to strengthen its existing warning. The category of drugs affected by the warning is known as non-steroidal anti-inflammatory drugs (NSAIDs), and includes the following popular OTC pain medications:

  • Ibuprofen such as Motrin and Advil
  • Naproxen such as Aleve
  • Various cold and flu medicines
  • Although aspirin is also an NSAID, the warning does not apply to that drug at this time.

Because of their effectiveness at relieving pain and treating flu symptoms, headaches, muscle aches, minor injuries, and menstrual cramps, OTC NSAIDs are commonly used by millions of Americans. As of 2005, manufacturers have been required to add warnings to boxes and labels about the increased risk of heart attack and stroke, but as a result of the increased warning issued by the FDA all future labels will need to be more specific about the health concerns.

According to the FDA, the risk is strongest among people who have a history of cardiac disease and heart attacks, but given the new information the agency wants all consumers to be aware that use of NSAIDs could lead to heart attack or stroke in anyone. Additionally, the FDA noted that risks appear even in users who just started using the drugs, suggesting that health concerns are not limited to prolonged use of the drugs.

Instructions for Consumers

Despite the increased warning, the FDA informed consumers that they can still take NSAIDs, but they need to be aware of the increased risks of doing so, especially at higher doses. According to Dr. Karen M. Mahoney of the FDA’s Division of Nonprescription Drug Products, consumers should be careful to check the list of active ingredients in a drug and avoid taking products that contains more than one NSAID at a time. Mahoney said of NSAID use, “As always, consumers must carefully read the Drug Facts label for all nonprescription drugs. Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible.”

Consumers with a history of cardiac disease or heart attack should be particularly wary of the use of NSAIDs to treat pain or flu-like symptoms, and the FDA suggested that people at high risk of heart disease consult a doctor before taking any prescription or OTC NSAID. Further, any consumer that uses NSAIDs and subsequently experiences symptoms that suggest they are suffering from heart problems such as chest pain, shortness of breath, sudden weakness in one side of the body, or slurred speech should contact a medical provider immediately.

Medical researchers at Stanford University have found evidence that common heartburn medications used by millions of Americans are associated with increased risk of heart attack. The drugs are known as proton pump inhibitors (PPIs) and include Nexium, Prevacid, and Prilosec, all of which are available over the counter without a doctor prescription.
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A medical panel of the US Food and Drug Administration (FDA) has recommended the agency require new warning labels for two diabetes drugs: Onglyza manufactured by AstraZeneca and Nesina by Takeda Pharmaceuticals. According to the FDA medical panel, both drugs carry increased risks of heart failure that consumers should be aware of before using them as treatment for type 2 diabetes. The FDA is not required to follow the panel’s recommendations, but it usually takes advisory committee reports into account when issuing new regulations.

The recommendation comes from the Endocrinologic and Metabolic Drugs Advisory Committee, which conducted a thorough review of DPP – 4 inhibitors, a class of drugs used to treat diabetes that contains both Onglyza and Nesina, before making its recommendation that the FDA require manufacturers to warn of the risk of heart failure. Although the FDA has not yet acted on the recommendation, the panel’s findings suggest that consumers should be aware of risks before taking the medication.
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Takeda Pharmaceutical Co. is attempting to settle nearly 8,000 Actos lawsuits across the United States by agreeing to pay $2.3 billion. The settlement has been called a good deal for the drug company which will avoid the threat of further litigation and potentially punitive damages awarded to litigants who claim Actos use is linked to the development and spread of cancer. If 95% of the claimants in Actos lawsuits accept the deal, it will be finalized and Takeda will make the payment.

Each plaintiff could receive close to $300,000 to accept the settlement, but that number could change for individuals who have a history of smoking or engaging in other behavior that contributes to the cause of cancer. If accepted, Takeda’s $2.3 billion Actos settlement would be one of the larger agreements by drug manufacturers to resolve litigation.
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Pharmaceutical giant Bayer recently sent out a press release announcing the continued safety of its non-surgical contraceptive, Essure. Earlier this month the New York Times published an article calling to question a study concluding Essure as a safe permanent contraceptive, prompting a public response from Bayer in defense of its product. Bayer’s public stance on Essure comes as the FDA has opened an investigation into claims of harmful side effects suffered by women who underwent the procedure.

Essure procedures were approved for use as a non-surgical alternative to permanent contraceptives in 2002, and have been since re-evaluated by the FDA in 2013 when Bayer purchased Conceptus, the company that designed the Essure device. The Essure device consists of small coils which are placed inside the fallopian tubes. Once in place the coils trigger an inflammatory response that causes scar tissue to form and block the fallopian tubes and prevent sperm from reaching the ovum. Recent legal claims against Bayer allege that manufacture and promotion of Essure has negligently put its users at risk of side effects including heavy periods, severe pelvic pain, and organ perforation.
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Diabetes drugs taken by millions of Americans may be linked to an increased risk of pancreatitis and pancreatic cancer (a disease with one of the lowest cancer survival rates). More than 12 million prescriptions were filled, in the United States, in 2012 alone. These increasingly popular GLP-1 (glucagon-like peptide) drugs (such as Byetta and Victoza) and DPP-4 drugs (such as Junuvai, Onglyza, Nesina and Tradjenta or Trajenta) should be added to the list of diabetes drugs like, Avandia and Actos, among others, that have recently been the subject of causing serious and deadly side effects. Back in April 2012, Public Citizen’s Health Research Group (HRG) petitioned the FDA to ban Victoza after studies found “it puts patients at higher risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure that outweigh any documented clinical benefits.”
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The U.S. Food and Drug Administration (FDA) issued a stern warning to patients who take Janssen Pharmaceutical’s Nizoral (generic name ketoconazole) oral tablets. In fact, the FDA issued a safety release advisiong that Nizoral should not be the initial treatment for any fungal infection. During 2012, approximately 5.2 million ketoconazole prescriptions were dispensed, of which 609,000 were for tablet formulation.
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A federal judge has opened a window for plaintiffs to make a claim for strict liability against prescription drugmakers on a manufacturing defect theory. Despite developing case law in the opposite direction, U.S. District Judge Malachy Mannion of the Middle District of Pennsylvania ruled that Ryan Bergstresser could bring a manufacturing-defect claim against Bristol-Myers Squibb over its antipsychotic drug, Abilify. Bergstresser alleges he suffered from dystonia, which is characterized by involuntary muscle contractions, after his psychiatrist increased his dosage of the drug.