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In 1983, the FDA approved Depakote to treat certain issues with the central nervous system. It has successfully treated or controlled such disorders as epileptic seizures and episodes of manic or bipolar behavior. This medicine can also be prescribed for migraine headaches. It is primarily used as a mood stabilizer and anti-convulsant, which has also provided relief for certain off label conditions.

After years of tests and research, there have been recent studies that have identified issues with this medication. Unfortunately, this is a far too common, because even the vigorous tests that were run by the FDA can miss potentially fatal side effects. In 2009, the FDA warned pregnant mothers about certain congenital birth defects such as a cleft palate, spina bifida, malformed hands and autism.

Again, in 2011, the FDA notified consumers of other possible side effects. The results of studies by Emory University have given cognitive tests to children from 3 to 6 years old. The results have shown that children of mothers who took Depakote while pregnant tended to score lower on IQ tests than mothers who took other anti-seizure medications during pregnancy.

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Modafinil is a medication that was created to treat shift work sleep disorder, narcolepsy and excessive sleepiness during the day as created by sleep apnea. This drug is only approved by the FDA to treat those symptoms. It works in a similar manner as a stimulant but because its effects on the human bodies are different, it is often referred to as a “wakefulness promoting agent”.

Yet, there has been an alarming increase in the usage of Modafinil for off-label disorders such as multiple sclerosis and depression. This is according to a new study initiated by Dr. David Claman and other colleagues from the University of California in San Francisco. From 2002 to 2009, this team took data from national Modafinil prescriptions and came to certain conclusions.

The results were staggering as the amount of prescriptions grew from nearly 60,000 to over 550,000. People receiving this medication for off-label conditions caused 89% of the increase. The side effects of the medication include headaches, drowsiness, stomach issues and dizziness. There have also been some cases of serious allergic reactions to the liver.

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The Food and Drug Administration (FDA) recently announced a recall for one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, because these tablets may actually contain Meclizine HCl 25 mg tablets. Meclizine HCl is given for the treatment of nausea and vomiting. According to the FDA's press release, ingesting Meclizine HCl 25 mg as Ferrous Sulfate 325 mg “may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.”

The problem was discovered by a pharmacist, who complained to the manufacturer of the Ferrous Sulfate, Advance Pharmaceutical Inc. The company immediately issued a voluntary recall. The tablets were sold with the label Rugby Natural Iron Supplement Ferrous Sulfate in 100 count bottles. The lot of Rugby Ferrous Sulfate is 12G468 and expires on 7/14.

A patient who has been prescribed a daily dosage of three Ferrous Sulfate, but received the defective product, would be actually be taking 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Taking the medication three times per day instead of once per day could also lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose. Side-effects of meclizine toxicity include impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. The effects can even become life-threatening.

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The FDA is now requiring sleep aids such as Ambien, Ambien CR, Edluar and Zolpimist to lower their dosage. Zolpidem, an ingredient in these brands, may remain in the blood the next morning in high enough levels to impair certain activities that require alertness.

Zolpidem is eliminated slower from women's bloodstreams, so the FDA is notifying manufacturers to lower the recommended dose for women—and they suggest lowering it for men as well. Especially in the extended-release form, zolpidem can cause problems the following morning for some activities, such as driving.

The FDA says in this article from January 10 that dosage for women should be cut in half (from 10mg to 5mg in immediate release pills, and 12.5mg to 6.25mg in extended-release) and the lowest possible dosage should always be used, regardless of sex. In addition, any patient that has complex tasks in the morning should talk to their health care professional to see if a sleep aid is the best choice for their lifestyle.

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The Zoloft lawsuit currently has 250 claims that are now pending for the Zoloft Litigation that is underway in the Pennsylvania Federal Court.

In the Easter District of Pennsylvania, the Zoloft lawsuits continue to move forward in the multidistrict litigation that is currently underway in the U.S. District Court. There have been at least 250 cases filed in the Pennsylvania litigation by plaintiffs whose alleged use of Pfizer's antidepressants during pregnancy has caused birth defects in their children. Overseeing the federal Zoloft litigation is U.S. District Judge Cynthia Rufe, who issued Pretrial Order No. 15 on November 25, 2012. This order set forth a joint discovery of scheduling a plan for the proceedings.

The nationwide law firm that is representing these victims of defective drugs and medical devices said, “We are pleased to see the federal litigation moving forward, and expect more complaints to be filed in the coming months.” The firm is also offering help to those victims of birth defects that may be associated with Zoloft.

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