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FDA Orders New Label for Powerful Painkiller After Several Reports of Overdose

By January 14, 2011July 18th, 2019Dangerous Drugs

As a defective drug attorney, I was displeased to see reports of death and serious illness from a prescription painkiller. As MedPage Today reported Jan. 11, the FDA has ordered new labels for an oral morphine sulfate drug sold by Roxane Laboratories. The drug had been labeled as 100 mg per mL, which apparently confused some users. That confusion led to drug overdoses with as much as 20 times the ordered amount of the drug, causing deaths and serious illnesses, the FDA said. The 100 mg/mL drug may also have been mistaken for a less concentrated version, also leading to overdose. The agency ordered a new label for the morphine sulfate distinguishing the 100 mg/mL version from less potent versions. An oral syringe will come with the drug to make correct administration easier.
Morphine was sold throughout the 20th century, but the morphine sulfate preparation sold by Roxane was approved by the FDA only in 2010, because drugmakers had never applied for FDA approval. That approval was important, because morphine is a powerful opioid painkiller with potential for both addiction and overdose. At high doses, morphine can cause breathing problems leading to death or brain damage. The 100 mg/mL morphine sulfate solution that got the label change is already a high dose. It is intended for people who are known to have an opioid tolerance, and thus need a higher dose, and for people who are receiving hospice or palliative care. The old label reportedly made that problem worse by giving the strength in mg/mL even though dosages are ordered in mg. As a result, people unfamiliar with the drug gave the doses in mL, increasing its already strong potency considerably.
The FDA’s order for a new label takes several steps to ensure that the high-potency morphine sulfate is hard to confuse for lower doses, and includes an oral syringe so that users have the tools to give the correct dose. As a pharmaceutical liability lawyer, I’m pleased that the FDA is taking these steps — but I’m surprised it was necessary. Most Americans don’t use the metric system, so it’s not a surprise that some users were confused by the dosage instructions for this morphine. Furthermore, calculating a dosage in mg from a drug measured in mg/mL requires math that most people won’t have memorized. It’s not hard to predict that busy or distracted users could miss the distinction and simply measure out a dose. Unfortunately, with such a powerful drug, the consequences of this kind of casual mistake can be deadly.

If you or someone in your family was hurt by a prescription drugs with defects or labeling errors, you should call Carey, Danis & Lowe right away. We represent clients who were sickened, injured or lost a loved one because of the negligence of a pharmaceutical company. Frequently, evidence shows the company knew there was a serious safety problem with the product — but kept selling it anyway, to protect its profits. Nonetheless, all manufacturers have a legal obligation to warn patients — and are legally liable for injuries caused when they fail in that duty. Our defective medication attorneys help clients collect damages for injuries caused by a drug company’s irresponsible failure to warn about serious safety defects. That includes payment of all past and future medical bills, lost income and compensation for pain, suffering, disabilities and more.
Carey, Danis & Lowe offers free, confidential case evaluations, so you can talk to us at no further risk or obligation. To set up a meeting, send us a message online or call 1-877-678-3400.