Selective Serotonin Reuptake Inhibitors (SSRIs) are types of antidepressants. Brand names of SSRIs include: Paxil, Zoloft, Celexa, Prozac, Lexapro, Symbyax, Wellbutrin and Effexor. These drugs inhibit neuronal serotonin and norepinephrine reuptake and slightly inhibit dopamine reuptake. SSRIs have been associated with serious, life-threatening birth defects. Research suggests that, if a mother took SSRI’s during pregnancy, [...]
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FDA Delay in Banning Propoxyphene (Darvon and Darvocet) May Have Caused Deaths
Edward F. Blizzard wrote in the Huffington Post (11/24), “When the FDA pulled from the market the sometimes-deadly prescription painkiller propoxyphene (sold under the brand names Darvon and Darvocet in the US), the agency was acting finally — if belatedly — in the public interest.”
Blizzard added, “So risky and dangerous is propoxyphene that the United Kingdom banned the drug in 2005 and the entire European Union followed suit in January of 2009.” Propoxyphene (Darvocet and Darvon) is associated with abnormal heart rhythms that can lead to death.
Xanodyne Pharmaceuticals, Inc. pulled the brand-name propoxyphene drugs, Darvon and Darvocet (as well as their generics), from the market on November 19, 2010. Blizzard continued, ”for thousands of Americans, the FDA’s action comes decades too late.”
FDA Pulls Darvon and Darvocet
Xanodyne, the pharmaceutical company that makes prescription pain medications Darvon and Darvocet (propoxyphene), agreed to withdraw the drugs from the U.S. market at the request of the FDA. According to the FDA, propoxyphene puts patients at risk of potentially serious or fatal heart rhythm abnormalities. Since 2009, 10 million people have been prescribed some form of the drug.
Xanodyne Pharmaceuticals, Inc. manufactures Darvon and Darvocet, two brand name versions of propoxyphene. The FDA also asked generic makers of the pain medicine to voluntarily remove their products. FDA Xanodyne Release
Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).
The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the FDA concluded that the risks of the medication outweigh the benefits.
Data from that study shows that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram, can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.
If you or a family member suffered serious adverse effects, including sudden death, from the use of propoxyphene (Darvon, Darvocet or a generic), please contact us. One of our experienced pharmaceutical attorneys would be pleased to assist you in seeking legal remedies. Please complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.
Novartis Accused of Hiding Risks of Bone-Strengthening Medications
Bloomberg News (11/19 Feeley, Adams) reported that lawyers for a North Carolina woman said that ”Novartis AG officials hid the health risks of the drugmaker’s bone-strengthening medicines Aredia (pamidronate disodium) and Zometa (zoledronate) to protect billions of dollars in sales.” A federal court jury in Winston-Salem, NC was told that Novartis “ignored studies showing that some cancer patients taking Aredia and Zometa may suffer irreplaceable jawbone damage.”
Lawyer Says Novartis Downplayed Risks of Bone-Strengthening Medicines
Bloomberg News (11/2, Feeley, Adams) reported that “Novartis AG officials downplayed risks that bone-strengthening medications Aredia (pamidronate injection) and Zometa (Zoledronic acid) could destroy patients’ jaws.” In opening statements, attorneys stated that officials of the drug company received reports from physicians as early as 2002 that cancer patients who took Aredia and Zometa to prevent bone loss had suffered irreplaceable jawbone damage.