Yourlawyer.com (Reminyl News) http://www.yourlawyer.com/topics/overview/reminyl Sat, 21 Nov 2009 08:48:27 -0800 pixel-app en Pharmacies Ignore Pullout Order, Sell Harmful Ophthalmic Solution http://www.yourlawyer.com/articles/read/11919 Mon, 26 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11919
Bausch & Lomb, the manufacturers of the contact lens clearing solution ReNu with MoistureLoc, announced their decision to call back the product from markets worldwide due to a high rate of eye infection associated with it. The Saudi Ministry of Health also issued a precautionary note around the same time.

Pharmacies visited by Arab News said they were not aware of the circular or of the harm the product might cause to the eye until last week. Although many pharmacies have removed the product from their shelves, some continue to sell it.

According to a statement issued by the US Food and Drug Administration (FDA) on May 15, the multinational eye care company Bausch & Lomb, which has its headquarters in Rochester, New York, decided to permanently withdraw ReNu with MoistureLoc due to data suggesting that the liquid may increase susceptibility to Fusarium Keratitis, a fungus that causes an eye infection affecting the cornea and which can lead to total blindness.

The Centers for Disease Control and Prevention (CDCP) is investigating the multi-state outbreak of Fusarium Keratitis that may be associated with contact lens use.

However, the risk of getting the fungus from contact lenses remains extremely low. Contact lens wearers who experience unusual redness, pain, tearing, light sensitivity, blurry vision, discharge or swelling should consult their doctor immediately. The CDCP is continuing its investigation to identify specific factors that may have placed people at risk for developing the infection, including hygiene practices, overnight usage and specific solutions used.

The Saudi Ministry of Health issued warnings in the local papers a month ago about possible infections associated with the use of ReNu with MositureLoc. Last week pharmacies began receiving a circular from the ministry ordering them to remove all ReNu brand products. They were also informed of the pullout by the distribution agent.

“I only found out about the circular a few days ago from my neighbor who is an optician,” said pharmacist Mohammed Fathi.

The optician, Osama Hussein, said many pharmacists he encountered have not read the reports in the papers nor have they received the circular. “There hasn’t been any follow-up from the ministry to check on whether the product has been removed from the shelves or whether it is still being sold,” he said.

ReNu products, especially ReNu Multiplus, are the most common brands bought by contact lens users, according to pharmacists.

Manal Ahmed, 36, has been using ReNu for the past seven years. She bought ReNu with MoistureLoc last week from a local supermarket and did not know that it was harmful and was supposed to be pulled out.

“This (Fusarium Keratitis) is a very rare type of fungus and we have not received any cases here until now,” said Dr. Ihab El-Hawary, ophthalmology consultant at El-Maghrabi Eye Center on Madinah Road. “Although it might affect contact lens wearers, especially those who use distilled water to clean their lens, it mainly affects people who work in agriculture or have low immunity due to diseases such as cancer, uncontrolled diabetes or have some kind of organ transplant,” he explained.

Even if there were some cases in the Kingdom, they might not have been reported or diagnosed correctly, said Dr. El-Hawary.]]> Reminyl (galantamine) Precautions due to Deaths Reported in Clinical Trials http://www.yourlawyer.com/articles/read/9543 Fri, 01 Apr 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9543
March 31, 2005

Dear Healthcare Professional:

The REMINYL(galantamine hydrobromide) Prescribing Information has been updated with the addition of the following information regarding the results of two investigational studies of REMINYL in individuals with mild cognitive impairment. REMINYL is approved only for the treatment of mild to moderate Alzheimers Disease. No indication is being sought for the treatment of individuals with mild cognitive impairment.

PRECAUTION

Deaths in Subjects with Mild Cognitive Impairment (MCI)

In two randomized, placebo-controlled trials of 2 years duration in subjects with mild cognitive impairment (MCI), a total of 13 subjects on REMINYL(n=1026) and 1 subject on placebo (n=1022) died. The deaths were due to various causes which could be expected in an elderly population; about half of the REMINYL deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death).

Although the difference in mortality between REMINYL and placebo-treated groups in these two studies was significant, the results are highly discrepant with other studies of REMINYL. Specifically, in these two MCI studies, the mortality rate in the placebo-treated subjects was markedly lower than the rate in placebo-treated patients in trials of REMINYL in Alzheimers disease or other dementias (0.7 per 1000 person years compared to 22-61 per 1000 person years, respectively). Although the mortality rate in the REMINYL-treated MCI subjects was also lower than that observed in REMINYL- treated patients in Alzheimers disease and other dementia trials (10.2 per 1000 person years compared to 23-31 per 1000 person years, respectively), the relative difference was much less. When the Alzheimers disease and other dementia studies were pooled (n=6000), the mortality rate in the placebo group numerically exceeded that in the REMINYL group. Furthermore, in the MCI studies, no subjects in the placebo group died after 6 months, a highly unexpected finding in this population.

Individuals with mild cognitive impairment demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimers disease.

IMPORTANT PRESCRIBING INFORMATION

These investigational trial results have been presented at international scientific meetings as well as in a press release, and also have appeared on Health Authority web sites in many countries of the world. Ortho-McNeil Neurologics, Inc.,* remains committed to providing you with the most current product information available for the management of your patients. Please refer to the enclosed package insert for full Prescribing Information.

Sincerely,
Joseph Hulihan, MD
Vice President, Medical Affairs
Ortho-McNeil Neurologics, Inc.]]> Trials Show Higher Death Rate Among Some Test Subjects Using Reminyl http://www.yourlawyer.com/articles/read/9250 Sat, 22 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9250
The patients had mild cognitive impairment, and the J&J company is no longer pursuing Reminyl as a treatment for the condition and has not submitted any applications for such use, spokeswoman Carol Goodrich said.

Reminyl was approved in 2001 as a treatment for mild to moderate Alzheimer's disease. The higher death rate was not observed in Alzheimer's trials, Goodrich said.

While mild cognitive impairment can be a precursor to Alzheimer's disease, it does not always progress to dementia or Alzheimer's, she said.

"The health authorities that are reviewing this data ... are still supporting its use for the approved indication, which is mild to moderate Alzheimer's disease," Goodrich said. It is approved in 69 nations for that use. The number of users was not available, she said.

The company is analyzing the data and is discussing it with regulators.

The Raritan-based company said it presented the information to authorities worldwide over the summer, and at two medical conferences. Friday's announcement was made as authorities in Canada and Europe were to disclose the information, she said.

The investigational studies involved 2,000 patients in 16 countries over two years. Mortality rates were low in both the Reminyl and placebo groups, compared to expected rates in this population or in patients with Alzheimer's disease. Of 20 deaths, 15 were among the group taking Reminyl, the company said.

J&JPRD developed Reminyl with Shire Pharmaceuticals Group PLC. Janssen Pharmaceutica Products LP manufactures and markets it in the United States. ]]> Reminyl Increased Date Rate Side Effects Attorney http://www.yourlawyer.com/topics/overview/reminyl Sat, 22 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/reminyl DOWNLOAD OUR REMINYL INFORMATION PACKAGE

Injured by Reminyl?

Data from two clinical trials indicated that people taking Reminyl (Generic: Galantamine) have a much higher death rate than those taking a placebo. Reminyl is an Alzheimer's disease drug. The review was announced on 1/21/05 by Johnson & Johnson, which said it's in discussions with the Food and Drug Administration and regulators in Europe and Canada.

The trials, involved approximately 2,000 patients in 16 countries. were looking if Reminyl could be used to treat mild cognitive impairment, a form of memory loss that is often associated with Alzheimer's. Reminyl is approved in 69 countries as a treatment for mild to moderate Alzheimer's but not for mild cognitive impairment. In the trials, which lasted two years, 15 patients taking Reminyl died compared with 5 taking the placebo.

The announcement comes at a time of heightened concern over the safety of widely used drugs after the withdrawal from the market of Merck's pain reliever, Vioxx, which studies indicated posed an increased risk of heart attacks and strokes. Johnson & Johnson responded by saying that the overall number of deaths in the trials was low for the elderly population in the trial and that the incidence of serious side effects was the same for patients getting the drug and the placebo. Also, it said, the investigators in the trials had not thought the drug caused any of the deaths.

Reminyl was approved on the basis of six-month studies but the mild cognitive impairment trials lasted two years, increasing their chances of detecting side effects. Nevertheless, the Johnson & Johnson analysis said the excess of deaths in the mild cognitive impairment trials was evident by six months, while no such excess was seen in the Alzheimer's trials.

Reminyl was developed with Shire Pharmaceuticals of Britain. Sales for Johnson & Johnson are estimated at about $200 million a year. Public Citizen, the watchdog group, recommends against using Reminyl or other drugs in its class, saying they have minimal benefit and the effectiveness and safety of taking them longer than six months is not known, according to Sidney Wolfe, director of health research.

If you or a loved one took Reminyl and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>