Subscribe to RSS

Posts tagged as: FDA back to homepage

Aegerion Pharmaceuticals Has Drug Approved Aegerion Pharmaceuticals Has Drug Approved

The U.S. Food and Drug Administration announced it had approved an Aegerion Pharmaceutical drug for a cholesterol disease that is very rare, but the drug will require safety precautions due to its potential liver toxicity.

Juxtapid, the approved drug, is the first drug approved for Aegerion. Now investors will watch to see if the company will be able to navigate the commercializing challenges for the newly approved drug for the rare disease.

Juxtapid will have a warning label that is prominent and other requirements will be needed that could cause a four month delay before new patients can receive the treatment.

Marc Beer, the CEO of Aegerion, said the requirements consistent with those that the company had proposed to the regulatory agency. The warnings will ensure the patient’s safety and long term adoption to the product. Beer said he believed the FDA was right about the drug and understood the disease.

The drug will be utilized to help patients who have homozygous familial hypercholesterolemia or HoFH. This is a rare genetic disorder causing potentially fatal buildups of bad cholesterol known as LDL-C.

Estimates are that more than 3,000 patients in the U.S. are eligible to start using the drug. The cost annually for the therapy is thought to be up to $300,000. Aegerion will have to train and then certify physicians, pharmacies and patients, while insurers must have payments pre-authorized for reimbursement prior to the drug being distributed to patients. The entire process could take up to four months before the patient actually has the medication to take, said Aegerion officials.

In January, the sales process will start for Juxtapid. Aegerion said more details would be provided about the launch of the drug, the sales force and financial guidance for the company for 2013. The company also said it was expecting a decision by regulators in the European Union sometime in mid-2013.

On Monday, shares of Aegerion stock fell to $25.25.

Gattex Approved by FDA for Short Bowel Syndrome Gattex Approved by FDA for Short Bowel Syndrome

Gattex (teduglutide) has been approved by the U.S. Food and Drug Administration to be used in patients that have short bowel syndrome and require parenteral nutrition.

The drug, once it is in the market, will compete against two others that have been approved by the FDA for this type of patient population. Those two medications are Nutrestore (glutamine) and Zorbtive (Somatropin).

Short bowel syndrome comes on following the removal surgically of part of the large or small intestine or part of both. Patients who are affected must have parenteral nutrition due to the poor absorption they have of nutrients and fluids. Teduglutide is injected one time each day and improves the absorption making it less important to have nutrition assistance.

The advisory committee for the FDA voted unanimously in October to recommend the drug’s approval after seeing the results from a pair of clinical trials that showed the advantage teduglutide had over just a placebo in at least a reduction of 20% in the amount of parenteral nutrition at 6 months.

During the first clinical trial, 46% of the patients that took the drug saw a level of reduction, which was compared to only 6% who had taken only a placebo. In the other study, the figure increased to 63%, while the placebo rated was up to 30%

The side effects most common found in those who use teduglutide during the trials included nausea, reactions around the injection site, abdominal pain abdominal distension and headaches.

Doctors Say Birth Control Bills Should be Over the Counter Doctors Say Birth Control Bills Should be Over the Counter

November 25, 2012- The largest group in the country of gynecologists and obstetricians says that birth control pills, like condoms, should be available over the counter. The group said doctors should not have to perform an exam and write a prescription for the female. The opinion by the group came as a big surprise for many.

Women’s advocates praised the announcement as they have been fighting of a longtime to make the pill easier to get. However, a change will not be very quick in coming, as the manufacturer of the pill would have to request government approval to sell it without a prescription. It is unclear whether any of the companies that manufacture the pill are even asking the FDA to approve them without a prescription.

In addition, a new set of questions exist about what that type of move would mean for women’s wallets, if insurance no longer covered the cost of birth control. Nevertheless, it seems momentum to change the pill’s availability is building.

Currently anyone who is 17 or older does not need to visit a doctor before they can purchase the morning after pill. That pill is a higher dosage that the normal birth control pill and can prevent a female from getting pregnant if taken just a short time after having unprotected sex.

A meeting was held earlier in the year by the U.S. Food and Drug Administration to receive ideas about the sale of oral contraceptives that do not require a prescription.

Questions have been asked why doctors, who are the ones making money from yearly visits from women on the pill, are advocating changing the process.

Fifty percent of the pregnancies in the nation are unintended each year and that rate has remained the same the past 20 years. Doctors say that having easier access to the pill could help to lower that rate.

FDA: Monster Drink Cited in at least Five Deaths FDA: Monster Drink Cited in at least Five Deaths

October 23, 2012- The U.S. Food and Drug Administration recently released incident reports that said at least five people might have died over the last 36 months after drinking the popular energy drink Monster Energy that is laced with caffeine.

The reports, like other filings in cases that involve medical devices or drugs, does not prove any links between the deaths and Monster Energy or possible health problems. The mother of a girl in Maryland, who was 14 years old when she died last December, obtained the records. The Maryland girl died due to a heart arrhythmia after she drank Monster drink in large cans for two consecutive days.

The teenager’s mother, Wendy Crossland, filled a lawsuit last week against the company Monster Beverage, which is based in Corona, California. The lawsuit alleges that Monster did not warn about risks its energy drinks have. A company spokesperson last week said that company products were safe and did not cause the death of the teenager.

That same spokesperson, Judy Lin Sfetcu said that Monster did not know of any fatalities that had been caused by the Monster beverages. On Monday, the stock was down over 14% following the report in the New York Times about the filings at the FDA.

Shelly Burgess, a spokesperson at the FDA said the regulatory agency had been given reports about five deaths that are possibly tied to the energy drink and a report of a heart attack that was nonfatal.

Other incident reports contained information referring to different adverse effects like vomiting, abdominal pain, abnormal heart rates and tremors. The reports that were disclosed took place between 2004 and June of 2012. All five deaths took place in 2009 or later.

In the reports, there was nothing clear as to whether other factors were involved in the incidents such as drugs or alcohol. However, any incident reports the FDA receives regarding any product it has regulation authority of, usually understates the actual overall quantity of problems to a large degree.

FDA Warns against Online Pharmacies FDA Warns against Online Pharmacies

October 1, 2012 - On Monday, the U.S. Food and Drug Administration launched a campaign that warned consumers that the overwhelming majority of pharmacies online were offering many counterfeit drugs. According to the U.S. regulatory agency, only 3% of all pharmacies online that received a National Association of Boards of Pharmacy review complied with pharmacy laws and standards in the U.S.

The FDA said in a prepared statement that many pharmacies are using fake storefronts to make Internet users believe they are legitimate pharmacies. However, many of the products they provide the public are fake, have expired or for some other reason are unsafe.

The U.S. regulatory agency also said that many of the scams that take place on online pharmacies are very sophisticated and even members of the healthcare industry could have a hard time trying to detect if they are illegal or not.

In order to be safe says the agency, customers must make sure the pharmacy requires the purchaser to have a valid prescription before it dispenses medications and that is has a state license in the U.S. and a physical address.

The best result would be that customers received fake drugs that were not as strong and effective or had side effects that were unexpected. In addition, the agency said the online pharmacy sites could infect a person’s computer with a virus and could sell personal information to other website that are illegal.

Regardless of the warnings that have been issued previously by regulatory agencies in the U.S., close to 25% of Americans have purchased online prescription drugs due to the lower cost.

Mangos Recalled By Fruit Company Mangos Recalled By Fruit Company

1 September, 2012- The U.S. Food and Drug Administration is telling people in the U.S. to not eat Daniella mangos that have been distributed by a fruit distributor in Northern California. The health officials believe the mangos could be contaminated with salmonella, which has already stricken 100 people across 16 states.

The FDA issued its warning last Thursday after Splendid Products, based in Burlingame, California recalled five lots of imported mangos from Mexico. The mangos are marked with the brand sticker of Daniella. The health regulatory agency said that consumers should not consume the mangos and should throw them away if they have already purchased them.

The mangos in question were sold in a number of retailers in the U.S. from July 12 to August 29. The fruit distributor said it had voluntarily recalled the imported product under an abundance of caution following a meeting and consultation from the health agency.

Health officials continue to investigate what caused the salmonella Braenderup outbreak in the 103 cases. Both Canadian and U.S. authorities continue to try to identify which brands of mango or sources might have caused the outbreak of sicknesses. The Centers for Disease Control in the U.S. said that 78 of the people reported ill were in California. Thus far, the outbreak has not caused any deaths.

Canada’s Canadian Food Inspection Agency recently reported people falling sick from a strain of bacteria that was the same as in the recent outbreak in mangos in the U.S. Both Canadian and U.S. retailers said they would remove or recall all mangos that are Daniella-branded from their stores.

Headlines

Genocide Trial in Guatemalan Suspended Genocide Trial in Guatemalan Suspended
One Suspect in Boston Killed, one on the run One Suspect in Boston Killed, one on the run
Musharraf Flees as Bail is Revoked Musharraf Flees as Bail is Revoked
Some Say New Immigration Bill too Stringent Some Say New Immigration Bill too Stringent
read more