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FDA proposes rule changes to hold generic drug manufacturers accountable for injuries
The FDA has proposed new rules that would improve generic drug manufacturer accountability. More than 80 percent of prescriptions are for generic drugs. However, a gap in the law prevents those injured by a generic prescription drug from holding the manufacturers accountable in court. The proposed change would close this loophole.
Under the current rules, generic drug safety warnings must mirror their name brand counterparts. Last year, the Supreme Court ruled that generic drug makers cannot be held liable for injuries caused by their drugs because they have no control over their labels.
The Today Show investigated drug makers’ accountability in a special report last Friday. Reporter Jeff Rossen tells the story of Viola Purcell who contracted a neurological illness from taking a generic drug. The current FDA rules prevented her from holding the generic manufacturer accountable.
Watch her story below or read it here.
The new rules are open for comment for the next 60 days.
You can help people like Viola by signing the Take Justice Back petition that
urges the FDA to act quickly to restore justice for everyone who takes generic
The petition is online here: https://www.change.org/petitions/keep-our-medicine-cabinets-safe
USPLabs, the manufacturer of the diet supplement called OxyELITE Pro, has halted distribution of the drug nationwide following multiple cases of liver failure linked to the supplement discovered by the Hawaii Department of Health. The Hawaii Department of Health requested a voluntary removal of the supplement from store shelves across the state of Hawaii. It also asked the public to stop any use of the diet supplement.
Dietary supplements have been directly linked to 29 cases of liver failure and acute hepatitis in Hawaii within the past six months. Of those 29 cases, at least 24 were among patients who reported taking the OxyELITE supplement. One case has resulted in death.
Even though OxyELITE Pro had been sold all over the United States, all of the known hospitalizations and deaths from the supplement have taken place in Hawaii. It is possible that a bad batch was sold in Hawaii. Another reason could be exposure to heat, which has been known to alter pills’ effects.
“No other supplement or medication has been identified in common among more than two patients,” said Dr. Sarah Park, Hawaii’s state epidemiologist, in a Huffington Post article.
The request by the Hawaii Department of Health to remove OxyELITE Pro from all store shelves in Hawaii resulted in almost unanimous compliance among retailers across the state. One store, however, said no.
“GNC uniformly informed us there were not going to remove it,” said Gary Gill, Hawaii Deputy Director of Environmental Health, in another news article.
The U.S. Food and Drug Administration issued a ban earlier this year against supplements containing dimethylamylamine (DMAA). This includes OxyELITE Pro. However, USPLabs has reported that the original version of OxyELITE Pro containing DMAA has not been manufactured and distributed since early 2013.
An investigation into the product by the Hawaii State Department of Health is ongoing. The department is working with the FDA and Centers for Disease Control and Prevention. If the results of the investigation prove that the supplement is a health risk because of its formula or as a result of an contamination, the Department of Health will “seize and destroy” the supplement.Comments (1)
The hepatitis B warnings on two blood cancer drugs were recently strengthened by the Food and Drug Administration (FDA), according to Fox News. The strengthened warnings were issued to reflect the risk of reactivating the hepatitis B virus in patients previously infected with the disease who are taking the cancer drugs.
The warnings were strengthened for GlaxoSmithKline Plc’s Arzerra and Roche Holding AG and Biogen Idec Inc.’s Rituxan. Arzerra was approved in the United States in 2009 and is used to treat chronic lymphocytic leukemia (CLL). Rituxan was approved to treat CLL, non-Hodgkin’s Lymphoma and rheumatoid arthritis.
More patient deaths and reactivations of hepatitis B in patients have led to the need for the strengthened warnings even after the original warnings were placed. The strengthened warnings will now be black box warnings. This is the sternest warning given by the FDA to a medication while still remaining on the market in the U.S.
The FDA requires a black box warning for one of two reasons: either the drug may cause serious, life-threatening side effects, or serious adverse reactions can be prevented or reduced through proper use of the drug.
All physicians are recommended to screen patients for hepatitis B before prescribing Arzerra or Rituxan. Patients with prior history of hepatitis B should be monitored for signs that the virus has been reactivated. The FDA recommends physicians monitor patients for several months after therapy has stopped, as well.
Hepatitis B is a serious liver infection that can lead to life-threatening consequences, including liver failure, liver cancer or cirrhosis ( a permanent scarring of the liver). Because Arzerra and Rituxan work by suppressing the body’s immune system, which is essential in fighting off infections, patients with a history of hepatitis B are more susceptible to its reoccurrence.
Hepatitis B can be spread through contact with body fluids or blood, and it is best prevented through vaccination.Comments (0)
Recently, the Food and Drug Administration (FDA) announced that the commonly used anti-malaria drug, called mefloquine hydrochloride (brand name Lariam) must have a “black box” warning on its label. The drug has been linked to serious neurological and psychiatric side effects with the potential to cause permanent damage.
A black box warning is the sternest warning from the FDA that a drug can have while remaining on the pharmaceutical market. The FDA can require a black box warning if the medication can cause serious, harmful side effects (such as life-threatening or permanently damaging reactions) in comparison to the potential benefits of using the drug, or if a serious, potentially life-threatening reaction can be prevented, reduced in frequency or reduced in severity with the proper use of the drug.
Mild to serious side effects associated with mefloquine include:
- Ringing in the ears
- Loss of balance
- Psychiatric symptoms
The drug was first used in the U.S. Army and in 1989 it entered the commercial market. The manufacturer of Lariam, Roche, no longer sells it in the United States. However, generic versions are still available.
Mefloquine was previously favored among travelers because of its effectiveness in protecting against malaria and because it only needed to be taken once per week instead of once per day. Warnings on its label have steadily increased over the last decade.
According to the New York Times, mefloquine is the third-most-prescribed anti-malaria medication in the United States. Approximately 119,000 prescriptions have been written for the drug between January and June of this year.
The most common anti-malaria drug, hydroxychloroquine, was prescribed approximately 2.4 million times during that same time period.
Read the full story about Lariam and its strengthened warning now.Comments (0)
Calcium-channel blockers (CCBs) may be associated with a higher risk of breast cancer, according to a new study. Published in the journal JAMA Internal Medicine, the study looked at the effects of the long-term use of CCBs.
What are Calcium-Channel Blockers? (CCBs)CCBs lower blood pressure by preventing calcium from entering the cells of the heart and blood vessel walls. As a result, they affect the muscle cells in the arterial walls by relaxing and widening them. Some CCBs may also slow heart rate, relieve chest pain (angina) and help control a heart arrhythmia. Common calcium-channel blockers include amlodipine (Norvasc), diltiazem (Cardizem LA, Tiazac), felodipine, isradipine (DynaCirc CR), nicardipine (Cardene SR), nifedipine (Procardia, Procardia XL, Adalat CC), nisoldipine (Sular), and verapamil (Calan, Verelan, Covera-HS).
C.R. Bard, a medical technologies developer, manufacturer and marketer commonly referred to simply as Bard, has reached a settlement in the second lawsuit trial of the multidistrict litigation for its transvaginal mesh product. The amount of this second settlement has not been made public.
Bard agreed to settle the claims made by Wanda Queen of North Carolina, who stated that Bard’s Avaulta-branded vaginal mesh device caused her severe pain and forced her to undergo six surgeries.
The announcement comes approximately one week after a federal jury found Bard had failed to warn consumers of the potential health hazards associated with its transvaginal mesh product and awarded $2 million in damages to a Georgia woman. According to court records, the product was also the Avaulta-branded vaginal mesh device.
Thousands of other similar transvaginal mesh claims against Bard are currently pending. Results of these trials could indicate positive potential for other claimants injured by Bard’s transvaginal mesh product.
Transvaginal mesh has been associated with many harmful health complications. The Food and Drug Administration (FDA) has issued Public Health Notifications about the serious complications and side effects linked to surgical mesh.
Specifically, the FDA has stated that serious complications associated with the use of transvaginal mesh for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common. The FDA has pointed out that it is not proven that using transvaginal mesh for POP is more effective than using non-mesh repair in patients with POP. For this reason, using transvaginal mesh may actually expose patients to greater risk of health problems.1
Serious complications linked to transvaginal mesh include:
- Erosion through vaginal epithelium
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Bowel, bladder and blood vessel perforation during insertion
- Vaginal scarring
- Mesh erosion causing discomfort, pain and/or dyspareunia
Swiss pharmaceutical giant Roche has stopped further development of its new diabetes drug called aleglitazar. This decision could increase safety concerns for drugs similar to aleglitazar, including the controversial medication called Avandia.