On April 1, 2020, the FDA requested manufacturers of ranitidine (Zantaxc) to immediately withdraw all prescription and over-the-counter ranitidine products from the U.S. market due to a contaminant known as N-Nitrosodimethylamine (NDMA) found in the medicines. The FDA determined that… Read More
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FDA Strengthens Warning Regarding Clozapine And Untreated Constipation
In a January 28, 2020 Drug Safety Communication entitled “FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems,” the FDA stated that it is “strengthening an existing warning that constipation caused… Read More
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Alabama Supreme Court Affirms Dismissal Of Untimely Drug Claim
The Supreme Court of Alabama (“Alabama Supreme Court”), in its decision released on September 27, 2019, affirmed the trial court’s dismissal of the plaintiffs’ amended complaint that alleged that the plaintiff husband developed demyelinating polyneuropathy as a result of being… Read More
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Zantac OTC Recalled By Sanofi Due To Possible Contamination Concerns
Ranitidine is the active ingredient in Zantac®, which prevents or relieves heartburn by reducing the production of stomach acid. On October 18, 2019, Sanofi, which manufactures Zantac OTC, announced: “As a precautionary measure, Sanofi will conduct a voluntary recall of… Read More
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$8 Billion Risperdal Punitive Damages Award
A Philadelphia jury awarded a Maryland man $1.75 million in compensatory damages (which was later reduced to $680,000) against Johnson & Johnson’s subsidiary unit, Janssen Pharmaceuticals Inc. (“Janssen”), in 2015 but the jury was not permitted at that time to… Read More
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Maryland School Board Sues Pharmaceutical Company For Drug That Used To Cost $40 And Now Costs $40,000
The Washington County (Maryland) Board of Education has filed a lawsuit against pharmaceutical company Mallinckrodt ARD Inc. (“Mallinckrodt”), alleging that Mallinckrodt engaged in an unjust, unfair, and deceptive scheme and conspiracy along with its exclusive distributor, Express Scripts, to artificially… Read More
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At Least 34,000 Deaths Associated With Biologic Drugs Since 2004
The Milwaukee Journal Sentinel conducted an analysis of data from the FDA and found “at least 34,000 reports to the U.S. Food and Drug Administration of people who died while using biologic drugs since 2004.” The analysis further found, “More… Read More
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Drug Manufacturers Will Be Required To Disclose Drug Prices In TV Advertisements
The Secretary of the U.S. Department of Health and Human Services announced on May 8, 2019 a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare… Read More
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Maryland’s Opioid Operational Command Center Reports Increase In Opioid-Related Deaths In 2018
The Maryland Opioid Operational Command Center issued its “Opioid Operational Command Center Annual Report January 1, 2018 – December 31, 2018” on May 9, 2019, stating, “We have found that the rate of increase in the overall number of opioid-related… Read More
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FDA Warns About Aortic Tears/Ruptures Associated With Fluoroquinolone Antibiotics
The FDA issued a drug safety announcement on December 20, 2018 entitled, “FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients,” warning that fluoroquinolone antibiotics can increase the occurrence… Read More
