Category Archives: Dangerous Drugs

Freya-28 Birth Control Recall Raises Alarm Abroad

freya-28 birth controlA Freya-28 recall has recently been issued in Canada for the popular birth control medication. The recent birth control recall is the third one in six months. The recall has alarmed Canadian women and has raised questions about the quality of the drug plants that produce the birth control products.

Why was the Freya-28 recall issued?

The Freya-28 recall was issued because some of the pills contained placebo instead of actual birth control medication. This extra placebo can lead to unwanted pregnancies by women who use this product. The plethora of problems with birth control pills, the newness of Freya-28 to the market, and the delays in communicating the birth control recalls are a cause for concern. Approximately 430,000 birth control products had been prescribed to Canadian women as of June.

Other Birth Control Recalls Issued

Along with Freya-28, another generic birth control product was recalled because of placebo pills found inside the package. Esme-28 is one of the generic birth control products that were recalled. The Esme-28 and Freya-28 recall were issued a week apart. Esme-28 and Freya-28 are both produced in the same Indian plant overseas. Health Canada has yet to deny the possibility that the mistake occurred during the packaging process. There has yet to be an explanation as to why both birth control products have not been removed from shelves as soon as the Freya-28 recall was issued.

Just last April, another recall was issued for Alysena birth control products because of a placebo pill found inside the bottle. It took several days before a public announcement was made about the recall. The federal health minister is looking into the delay of the public announcement of the recall.

Alysena, Esme, and Freya have all been in the market for a few months. According to IMS Brogan, a health-tracker, there have been approximately 3,600 prescriptions made for Esme birth control products, 6,200 prescriptions for Freya, and 419,800 prescriptions for Alysena, all of which are in Canada.

Rona Ambrose, Canada’s Health Minister has issued a statement stating that she is waiting for the results of the reviews conducted by government agencies. She is also expecting Health Canada and drug producers to inform the Canadian public about the risk of using such products.

 

Four Deaths Blamed on Drugs from Compounding Pharmacy Recall

pharmacy mortar pestleVarious reports are claiming that Specialty Compounding, a Cedar Park-based pharmaceutical company, has manufactured certain products which claimed the lives of four individuals.

The Federal Food and Drug Administration (FDA) issued an announcement last week about a nationwide recall of all Specialty Compounding products. The said move came after several reports leaked involving 17 patients who found to have been infected by bacteria from the same products. These patients were all admitted in Corpus Christi Hospital.

According to a spokesperson from the Department of State Health Services in Texas, at least four of those patients died. However, investigation is still under way and so far, no direct link has been found between the death and the products.

Furthermore, nineteen individuals already expressed public support to various claims regarding the infections which were allegedly caused by calcium gluconate treatments. In fact, Thomas J. Henry, the legal representative from Corpus Christi Hospital, made an explicit statement regarding this claim in the hospital’s official website.

In addition, the Corpus Christi Medical Center also made a commitment to inform 114 patients who got infected by the said product, according to Corpus Christi Caller Times.

The Center for Disease Control and Prevention (CDCP), together with various Texas officials, strengthen its efforts to come up with a comprehensive analysis of the patient’s condition. The tests results will most likely be released next week.

According to some health experts in Texas, they have informed CDCP that all patients were all infected after they had been injected with calcium gluconate, a product manufactured by Specialty Compounding. In turn, CDCP officials claimed that they have studied a sample of calcium gluconate and discovered that the same bacteria were also present in the patient’s blood samples.

After this incident, Specialty Compounding has volunteered to recall all of its products including those that were already released and distributed since May 9 this year. In a written statement that was announced in Hill County News, the company’s representative informs everyone that the management of Specialty Compounding will fully cooperate with the authorities who are tasked to investigate this problem. According to the statement, Specialty Compounding gives high priority to “patient safety” and that they will ensure “that all recalled products” will be safely returned to their respective laboratories.

The company also adds that “the source of the bacteria still remains unknown and that all laboratory results will be made public once the investigation is already over.”

 

Ranbaxy Lawsuit: More Trouble for Leader in Generic Drug Manufacturing

Ranbaxy logoIndian firm Ranbaxy seemed to be at the top of its game when Japanese company Daiichi Sankyo bought 64% of the firm’s stake in 2008. But this large investment did little to remove the firm’s problems of regulator run-ins and safety scares. Now Ranbaxy is among the companies known for selling cheaper reproductions of expired popular medicines. The latest mishap from the company involves American regulators banning the factory’s imports.

The company hopes to settle the Ranbaxy lawsuit with the $500m settlement made with the US Department of Justice. The firm has also complied to producing safety data for its medicines, which Ranbaxy’s chief executive Arun Sawhney sees as the resolution to the previous problems. Yet the problems just keep coming for the firm.

Ranbaxy will have experienced its third ban imposed by the Food and Drug Administration: any medicines manufactured from the Mohali, Punjab plant are not allowed entry to the United States. This will be Ranbaxy’s third ban in the last five years.

The company suffered a 30% fall on sales when the ban was announced. Investors now have to problematize the delayed launch of Ranbaxy’s new generic drugs. Some of the latest generics that would have been released include the company’s own version of Diovan, a high blood pressure drug whose patent expired last year.

Prior to the Ranbaxy lawsuit and bans, Ranbaxy was enjoying over $1 billion sales in America. This number was half of the company’s total revenues. But the successful sale of patents placed the company under more scrutiny with the FDA.

When Dinesh Thakur joined Ranbaxy in 2003, he experienced several disapproving practices within the firm that led him to resign in 2005. He ended up charging the Ranbaxy lawsuit in 2007 for the data they invented just to get approval for manufacturing HIV treatment. It wasn’t until the $500m settlement was agreed upon that Thakur’s charge was made public.

Ranbaxy has experienced some success despite the charges, as the firm was given the approval to challenge the Lipitor patent and became the only generic Lipitor seller in 2011. But the ban issued by the FDA to the firm’s plants prevented Ranbaxy from distributing Lipitor generic exclusively to the American market. The firm has recently had to recall its pills as well since glass pieces were found inside.

Ranbaxy has been taking the FDA’s scruinty well, with Indian Pharmaceutical Alliance representative Dilip Shah welcoming the attention. The FDA’s action assures regulators and the public from other countries that Ranbaxy will meet international standards.

FDA Recalls Antiobiotic Cubin After Glass Bits Found In Vials

cubicinThe Food and Drug Administration (FDA) posted a Medication Safety Alert last August 29, 2013 warning patients and consumers of the recall issued by Cubist Pharmaceuticals of their antibiotic, Cubicin (Daptinomycin).

Reasons for recall

The recall was issued after glass particulates were found in some of the vials from the four lots of Cubicin shipped from May 2011 to March 2013.

The affected products, according to the report, include vials with lot numbers 950453F, 090203F, 201703F, and 201653F, and with expiration dates ranging from Dec. 6, 2013, to Sept. 1, 2015.

Supplier fault

Cubist Pharmaceutical report that the contamination of the Cubicin vials is due to manufacturing errors from the third-party supplier. And after finding out the presence of glass particulates in the vials, Cubist Pharmaceuticals have already suspended manufacturing with the third-party supplier until needed corrective and preventive measures have been implemented.

Danger to patients

Although no injuries have been reported so far because of the contaminated Cubicin vials, administration of intravenous drugs contaminated with glass particles can potentially cause serious health hazards to patients.

Glass particulates can potentially obstruct blood vessels causing thromboembolism. It can also cause blockage of capillaries, arterioles and veins. This is especially dangerous if major blood vessels and arteries are blocked like the major arteries in the lungs, leading to life-threatening pulmonary embolism.

The blockage of capillaries, arterioles and veins can further result to the activation of the body’s natural inflammatory responses including platelet activation, inflammation and granuloma formation.

Patients with pre-existing medical conditions that affect the body’s microvascular blood supply or patients with trauma are at higher risk of developing life-threatening conditions due to blood supply blockage of glass particulates.

Immediate action

Cubist Pharmaceuticals is already notifying its customers of the recall through letters and telephone calls. The company is also advising hospitals and clinics that use daptinomycin to check their inventories for Cubicin vials with the reported lot numbers and expiration dates.

The said contaminated vials should be quarantined and no longer be administered to patients. They can contact Cubicin Pharmaceuticals for the return and replacement of the contaminated daptinomycin vials.

Healthcare provider responsibility

Daptinomycin vials are already labeled with directions specifically for healthcare providers to check the vials for the presence of visible particles before administering the drug to patients. And vials that do contain visible particulates should not be used and discarded right away.

Daptinomycin Use

Daptinomycin (Cubicin) was approved by the FDA in September 12, 2003 for treatment of complicated skin infections and Staphylococcus aureus bloodstream infections (bacteremia).

What You Need to Know About Actos: Side Effects, Lawsuits and Recall Info

actosActos is one of the leading drugs when it comes to diabetes treatment and recently, a heightened interest on this drug has been brought to light because of Actos side effects which imply being the cause of bladder cancer incidences for patients who are taking the drug. The manufacturers are now facing federal Actos lawsuit cases.

What Consumers Have to Say about Actos Side Effects

According to various consumer reports, Actos is now being avoided as a diabetes drug because of its side effects. While a generic version of Actos has just been recently released in March and although the FDA or Federal Drug Administration has approved it, consumers avoid taking both branded and generic versions of Actos.

Product reviews and comments from diabetic patients mention how they would prefer to avoid taking Actos as their diabetic drug unless their other options have already failed. The also mention their preference of treating Actos as a kind of “last resort” only.

Recent Studies and Findings about Actos Side Effects

Also known as Pioglitazone, Actos belongs to the thiazolidinedione class of medicines. Its main use is for the treatment of diabetes mellitus and it works by increasing the insulin sensitivity of cells. Although the exact mechanism on how the drug increases bladder cancer risk is still unknown, here are some of the postulations and most recent study findings about the side effects of Actos:

  • Since cancer cells also happen to be affected by levels of insulin in the body, how Actos increases the insulin sensitivity of cells may be one of the factors that lead to increased cancer risks.
  • From animal studies, pioglitazone showed indications that it may lead to the development of solidification of particles that lead to crystal formation in the bladder.
  • Irritation caused by crystals formed inside the bladder may be one of the factors that lead to the development of bladder cancer.
  • A study conducted by the researchers from the University of Pennsylvania discovered that bladder cancer risks increased in conjunction with the increased intake and duration of Actos use.

In 2011, France had to implement an Actos recall after finding about its side effects. A year later, the University of Alberta School of Public Health also conducted a study on the side effects of this drug and found results which are in line with the findings of the study done by University of Pennsylvania researchers.

Bellwhether trials are being conducted in order for the courts to efficiently manage cases related to Actos side effects, specifically about its possible contributions to heightened bladder cancer risks in diabetic patients.

 

Voluntary Sandoz Recall Issued for Methotrexate Due to Quality Concerns

sandoz pharmaceuticals Sandoz, the generic pharmaceutical division of the company Norvartis, has been the second largest manufacturer of high-quality generic drugs in the world. But as with other well-known companies, Sandoz is not immune to lapses in quality and safety during the manufacturing process.

And the pharmaceutical company has recently conducted a voluntary recall of methotrexate sodium injectable products.

About the Methotrexate Recall

The Sandoz recall includes two lots of the methotrexate 25mg/mL 40mL vials. The said affected lots are CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013), reported to have been nationally distributed in the US and in Poland. Although there also have been reports that almost 24 lots of the said injectable drug was voluntarily recalled by Sandoz.

Glass Particulates Found Upon Inspection Leads to Sandoz Recall

The methotrexate recall was conducted after an inspection by the manufacturer showed the presence of glass particulates inside the vials. These tiny, glass particulate also known as reflective flakes, is due to the delamination of the glass inside the vials.

Glass delamination or the separation of the glass layers may be due to the chemicals from the drug solution itself or those used during the manufacturing process. And this can occur at any point in the vial’s life: during manufacturing, sterilization, heat treatment or during stability testing.

Potential Health Consequences of the Contamination

While there have not been reports of injuries regarding Sandoz’s methotrexate products, the presence of glass particulates in injectable drugs can have dire consequences in patients. These tiny glass particulates can cause the mechanical blockage of capillaries and arteries. This may lead to the release and activation of platelets. And subsequently the generation of microthrombi, which may ultimately lead to thromboembolism.

The blockage of capillaries and arteries is especially dangerous to patients with pre-existing conditions such as trauma, since this may lead to a further decrease in the much needed blood supply. Administration of drugs with glass particulates may also lead to granuloma formation, the body’s natural inflammatory response to the presence of foreign materials.

Company Action

Sandoz has already notified the US Food and Drug Administration of the voluntary recall. It has already contacted and notified health care providers, retailers, wholesalers, pharmacies, doctors and patients. It is also advising all hospitals and other health care institutions to stop the administration of methotrexate products that are part of the affected lots.

Despite the methotrexate recall, health care specialists are advising patients not to worry. The Sandoz recall only includes methotrexate products manufactured as 40mL vials and there are other methotrexate products that come in smaller vials.

If other similar drug products are not available, another option the patient can do is take the methotrexate orally since the said drug is also available in oral forms.

FDA Expands Safety Alert to All Sterile Drug Products from NuVision

nuvision-pharmacyThe US Food and Drug Administration or FDA has issued an announcement alerting health care providers of concerns regarding the lack of sterility assurance on all sterile products manufactured and distributed by NuVision Pharmacy.

The FDA has expanded this alert warning to encompass all of the sterile products manufactured by NuVision, following a recent site inspection of a Dallas-based NuVision facility. During the said inspection, FDA investigators noted below standard sterile production practices that have raised concerns of the possible unsterility of all the products produced in the facility.

Previous Nuvision recall

Prior to the expanded alert status issued by the FDA, NuVision has already issued a Nuvision recall on their methycobalamin parenteral products. This was after investigations made by the FDA, showed lack of quality control precautions and lack of sterility assurance during the production of these methycobalamin products.

In connection to this, the FDA has also received adverse drug reaction reports of soreness at the injection site, fever and flu-like symptoms with the NuVision’s methycobalamin products.  There have not been, however, other adverse reaction reports concerning other NuVision products.

Serious health concerns

The US FDA as well as the World Health Organization or WHO, has set standards for good manufacturing practices which should be strictly followed by all pharmaceutical manufacturing companies, with emphasis on companies which produce parenteral products. These standards help assure the production and safe, effective and quality drug products.

The lack of proper sterile procedures might lead to the contamination of drug products. This is especially dangerous if parenteral products, similar to the products with NuVision recall, become contaminated by microorganisms. The harmful toxins, which most microorganisms produce, specifically those which are pathogenic, can lead to serious microbial infections in patients.

Some of these toxin related illnesses include fever or flu-like symptoms, gastroenteritis, diarrhea and abdominal discomfort.  And symptoms will vary depending on an individual’s susceptibility with the toxins from acute diarrhea to even death. But for immuno-compromised patients, AIDS and ICU patients for example, microbial contamination will potentially lead to death.

Immediate action required

Following the NuVision recall and FDA alert, the agency is asking hospital staff and health care providers to immediately check their current drug supplies for any sterile products from NuVision Pharmacy.

These products should no longer be administered to patients and should be quarantined until NuVision issues further public notifications and instructions on what to do with these NuVision recall products.

Moreover, patients who are aware of having been treated with NuVision Pharmacy products should immediately contact their physicians and other health care providers.