Articles Posted in Drugs

Published on:

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.

Published on:

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.

Published on:

Last month brought changes to forty (40) medical product labels (down from 48 changes in November), 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:

The FDA Safety Information and Adverse Event and Reporting Program is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health.

Because of problems that occurred when certain products were packaged and labeled at their Lincoln, Nebraska site, tablets from one product may have carried over into the packaging of another product, resulting in the possibility of a stray pill of one medicine being placed in the bottle of another product. This is being done as a precautionary measure, as Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.

Affected products are as follows:

Published on:

Another Accutane lawsuit in New Jersey ended on Thursday, this time with a hung jury instead of the usual: a big plaintiffs’ verdict. The jury had been out for a week; the trial lasted three weeks.

Accutane’s manufacturer Hoffmann-La Roche said in a press statement that it is “pleased that the jury concluded that [plaintiff] Tanna could not prove her case.” It said it looks forward to a retrial. I guess if you are wearing rose-colored glasses, that is how you would see it. Hoffmann-La Roche is taking a beating in these Accutane lawsuits. So maybe a tie is a huge win for them.

Published on:

Johnson & Johnson, eager to pad its record recall year before 2011 closes out, is recalling certain lots of MOTRIN IB because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer-level recall, meaning consumers do not need to dispose of or return the product.

There is no safety concern if consumers continue taking the product in accordance with its label; there may just be a delay in experiencing relief. The recall is NOT being made on the basis of any adverse events.

The lot numbers for the recalled product can be found on the side of the carton label. The recalled lots are as follows:

Published on:

In September, Topamax lawsuits pending in federal courts throughout the country were consolidated in Pennsylvania. The lawsuits allege birth defects in children whose mothers took Topamax. This blog post discusses these suits. If you have an interest in discussing a potential Topamax lawsuit, call 800-553-8082 or get a free online consultation.

Topamax is an antiepileptic medication. It is often prescribed, off label, as a mood stabilizer for patients with bipolar disorder. Topamax lawsuits claim that birth defects such as cleft lip, cleft palate, genital malformations, and other birth defects in children were caused by their mothers taking Topamax (topiramate).

Topamax and topiramate (generic) are manufactured by several companies. The lawsuits allege that manufacturers failed to warn both the public and regulatory agencies about the potential for birth defects if used during pregnancy. To give you some idea of who the bad guys are in this story, consider this: Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals agreed to pay more than $81 million dollars in fines in 2010 for illegal promotion of Topamax related to off-label psychiatric use. History is replete with the choice of profits over patients.

Earlier this year, the FDA issued a warning and required label changes to list oral clefts as a possible side effect of its use during pregnancy. Risk is the highest if used during the first trimester of pregnancy. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry show that infants exposed to antiepileptic drugs have a 0.38 to 0.55% prevalence of oral clefts, however, those exposed to topiramate have a 1.4% prevalence of oral clefts, nearly 3-4 times higher than other anticonvulsants.

Cleft palate is a condition in which the infant has a gap on the roof of the mouth which interferes with the normal functioning of the mouth including chewing and talking. To correct the birth defect, surgery is required. Surgery is generally required between 6 and 12 months of age and can take several surgeries, and years, to correct.

Continue Reading

Published on:

Let’s face it: the bellwether Foxamax trials are going very poorly for Fosamax plaintiffs and their lawyers. Very poorly.

Merck won another jury trial, this time in New York, which blamed osteoporosis drug Fosamax for jaw and dental injuries. This is Merck’s fourth Fosamax victory in five tries. The other: an $8 million verdict (reduced to $1.5 million).

There is no question that these cases have value. Even assuming this abysmal 20% rate is indicia of what we can expect in the future, do the math. These cases have meaningful value. That being said, if there is a global settlement of the remaining 2,000 cases, every loss chips away at the value of plaintiffs’ claims.

Published on:

A new study from Canada suggests that women who use relatively benign painkillers like ibuprofen and naproxen early in pregnancy may have an increased risk of miscarriage.

Researchers found that of nearly 52,000 Quebec women who had been pregnant, those who had taken these commonly used painkillers with a favorable safety profile were more than twice as likely to suffer a miscarriage. The study included all non-aspirin NSAIDs such as Advil, Motrin, Aleve, Naprosyn, and Celebrex.

Is there a cause-and-effect relationship? No one really knows. But pregnant women are already advised to avoid using any medication if they can. What should you do? I think that is something you want to address with your doctor. Everyone is different. But is it worth mentioning this study to your doctor? I think it is.