Articles Posted in Drugs

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Sandoz is recalling 10 lots of its generic oral contraceptive Introvale in the US, because of a packaging flaw.

The possibility that the packaging flaw will cause serious adverse health consequences are remote, and there are no reports to date of any adverse event. The recall is being made as a precautionary measure to minimize any potential of patients being impacted.

The lots were distributed only in the United States and were distributed between January 2011 and May 2012.

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A New Jersey judge in the Aredia/Zometa state court cases found that a Zometa plaintiff’s lawsuit had been dismissed, applying Virginia’s statute of limitations.

The case’s facts are, like many others in the Aredia/Zometa cases, sad. Plaintiff, a Virginia resident, developed osteonecrosis of the jaw after allegedly receiving infusions of Zometa.

Everyone agreed that Virginia’s substantive law applied. The court found that, if the substantive law of Virginia governs plaintiff’s damage claims, the defendant may assert applicable affirmative defenses under Virginia law.

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Last month brought changes to forty-three (43) medical product labels (slightly up from 39 changes in March), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary, which will identify the safety labeling section, the revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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Last month brought changes to thirty-nine (39) medical product labels (way down from 65 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary which will identify the safety labeling section, the revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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The FDA has announced that there is a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab) that has been obtained by some medical practices. Lab tests have confirmed that the Altuzan, an injectable cancer medication, contains no active ingredient. Altuzan, the brand name for Avastin in Turkey.

The FDA first warned in February that a counterfeit supply of the widely used Avastin had turned up in the U.S. The Wall Street Journal has traced that supply through a network of firms in Canada, Barbados, the United Kingdom, Denmark, Switzerland, Egypt, and Turkey.

Read more: http://www.foxnews.com/health/2012/04/04/fda-finds-new-batch-counterfeit-avastin/#ixzz1r527ZHxg

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Like most lawyers writing about mass tort drug injury cases, our firm is looking to attract potential hip replacement recall cases.

One means of accomplishing this goal – as opposed to providing real information that is of use to victims which attracts attention from the search engines – is to buy pay-per-click advertising. I’m philosophically opposed to pay-per-click because I feel like 90% of the clicks are other lawyers snooping around to see who is buying the placement.

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Last month brought changes to sixty-five (65) medical product labels (up from 63 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will view the detailed summary which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

Published on:

Last month brought changes to sixty-three (63) medical product labels (up from 40 changes in December), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will view the detailed summary which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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Pfizer Inc. has recalled 14 lots of Lo/Ovral-28 (norgestrel and Ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic), as an investigation found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.

These products are oral contraceptives indicated for the prevention of pregnancy. These tablets were manufactured and packaged by Pfizer Inc. and labeled under the Akrimax Pharmaceuticals brand.

As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product should notify their physician and return the product to the pharmacy.

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Cephalon has issued a recall for Treanda (bendamustine HCL). The recall affects the 25mg/8mL, and is marked as lot TB30111 with an expiration date of 12/2012. The recall was made after the presence of particulate matter found was found in a single vial which has since been identified as glass fragments.

Indicated for the treatment of chronic lymphocytic leukemia (CLL), the affected Treanda lot is packaged in 8 mL vials and was distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011.

The recall has been made in consideration of the potential safety issue and risk associated with the administration of this product lot. Potential adverse effects after the administration of solutions containing particulates may present as an embolus and result in disruption of blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly, as well as patients with micro- or macrovascular disease, such as cardiac and renal disease, who may be more at risk since their vasculature and end organs are already compromised. Treanda provides a reduced treatment time, as the infusion takes about an hour and can be done on an outpatient basis. Side effects of Treanda have been linked to potentially fatal skin reactions known as Stevens-Johnson Syndrome and toxic epidermal necrolysis. At least one death has been reported after a user experienced severe skin conditions from Treanda.